BARDA and OraSure Technology, Inc. are working together on the development of a point-of-care (POC) test for SARS-CoV-2 that could bring testing closer to the patient. OraSure’s rapid, point-of-care test will be available for use both in clinical settings and at home. This test could become the first for use at home in the United States.

No instruments or trained personnel are needed to administer the test or read the results. Test results are available to the user in approximately 20 minutes. Currently there are no rapid POC tests available for large volumes of testing that can be used during times of quarantine and social distancing.

This test is a quick, non-invasive antigen detection test that has the potential to be deployed quickly to and assess symptomatic and asymptomatic acute infections shortly after the patient becomes infected. Availability of a POC test will allow people to be screened and triaged within minutes rather than waiting several days for test results.

This test, which is built on OraSure’s OraQuick platform, will allow healthcare providers and agencies to distribute tests directly to an individual for testing, with the goal of minimizing exposure risks to others and reduce the threat of infecting others. Regardless if a POC or self-administered test, these early results would allow for faster diagnoses to enhance patient and community outcomes and quickly identify patients needing isolation. A rapid test would not only be a major step towards controlling this outbreak, but also benefit in preventing further spread of the virus by those infected.

BARDA’s support for this project include funding of approximately $710,000 of the $1.2 million project costs and technical support in order for OraSure to request Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).

About the Company

The following information is provided by OraSure and does not indicate endorsement by the federal government of the company or its products.

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries (DNA Genotek, CoreBiome, Diversigen and Novosanis), OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

BARDA has partnered again with Luminex Corporation, this time on the development of a COVID-19 sample-to-answer diagnostic. The test detects the presence of COVID-19 in nasal and throat swabs and can be performed in community hospitals and other facilities with access to medium-complexity laboratories, thereby greatly increasing the number of tests that can be run. BARDA will contribute approximately $642,000 of the total $1.7 million estimated project cost, and Luminex will fund the remaining development costs.

Luminex has designed an assay that runs on its FDA-cleared ARIES^® molecular diagnostic system for presence of COVID-19 by detecting the virus in respiratory swabs. The ARIES System is Luminex’s sample-to-answer, six-color, real-time PCR instrument. ARIES assays require little training, take less than five minutes of hands-on time, and produce results in about two hours.

The Luminex solution consists of the ARIES^® System and up to six cassettes. Each assay cassette contains all the reagents needed for nucleic acid extraction, amplification and detection for one sample. An operator adds the sample, in this case, a respiratory swab, to the cassette’s sample chamber, scans the sample ID and cassette, puts up to six cassettes in a magazine, and loads the magazine into the ARIES^® System. The system starts automatically and reports results without further operator intervention. The Luminex ARIES^® SARS-CoV-2 assay detects via PCR, two SARS-CoV-2 targets within the “N” gene, for improved accuracy.

This is the second Luminex diagnostic to be supported by BARDA. The first was Luminex’s NxTAG^® CoV Extended Panel which received FDA Emergency Use Authorization on March 27, 2020.

About the Company

The following information is provided by Luminex and does not indicate endorsement by the federal government of the company or its products.

Luminex Corporation, Austin, TX, develops, manufactures, and markets biological testing technologies in the clinical diagnostic and life science industries. The company has developed the ARIES^® System, a sample-to-answer, 6-color, real-time PCR instrument for use in moderate-complexity laboratories. ARIES^® assays require little training, take less than 5 minutes of hands-on time, and produce results in ~2 hrs. ARIES Systems are installed in nearly 200 US healthcare facilities.

BARDA is partnering with GenMark DX to develop an accurate, rapid coronavirus diagnostic for use in clinical and hospital labs. BARDA’s support follows a March 19 decision by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the GenMark’s ePlex SARS-CoV-2 test to detect SARS-CoV-2 in samples collected from people suspected of being infected with COVID-19.

Development undertaken with BARDA support should allow the company to complete the necessary studies to request FDA clearance of the ePlex^® Respiratory Pathogen v2 Panel to detect SARS-CoV-2 and other pathogens. This fifth BARDA-supported test increases domestic capacity in the current pandemic and any future outbreaks. Early, accurate diagnoses are essential to treating the infection and curbing the spread of disease.

BARDA will provide up to $749,000 of the total $1.4 million estimated development cost; GenMark will fund the remaining development costs.

About the Company

The following information is provided by GenMark Diagnostics and does not indicate endorsement by the federal government of the company or its products.

GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. Utilizing GenMark's proprietary eSensor^® detection technology, GenMark's eSensor XT-8^® and ePlex^® systems are designed to support a broad range of molecular diagnostic tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution^™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream, and gastrointestinal infections in a rapid, actionable timeframe.

BARDA and Luminex Corporation are collaborating on rapid development of the diagnostic test called the NxTAG CoV Extended Panel for COVID-19.

The test uses RNA to detect the presence of the SARS-COV-2 virus and is intended for use with the company’s IVD MAGPIX^® molecular diagnostic system. This high-throughput option will add test capacity in the U.S. on equipment currently installed in U.S. healthcare facilities. Test results are available in less than four hours.

Luminex already has begun shipping of the NxTAG^® CoV Extended Panel under Research Use Only (RUO) in North America, Europe and the Far East and has received FDA Emergency Use Authorization on March 27, 2020.

In this cost-sharing partnership, BARDA will contribute expertise and approximately 36 percent of the funding necessary to develop the test. Luminex will provide the remaining development costs.

About the Company

The following information is provided by Luminex and does not indicate endorsement by the federal government of the company or its products.

At Luminex, Austin, TX, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit luminexcorp.com.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide Mesa Biotech with technical expertise and up to $561,330 in immediate funding in support of its novel coronavirus disease (COVID-19) diagnostic test.

This funding from BARDA will support the development efforts required for Mesa Biotech to submit a request to the U.S. Food and Drug Administration (FDA) for potential Emergency Use Authorization (EUA) of the Accula COVID-19 point-of-care test.

The Accula COVID-19 test will leverage Mesa Biotech’s Accula Dock instrument that has been 510(k)-cleared and Clinical Laboratory Improvement Amendments (CLIA)-waived by the FDA for influenza point-of-care testing. Utilizing the Accula Dock, the new Accula COVID-19 test will provide molecular results for COVID-19 within 30 minutes from throat, nasal, or nasopharyngeal swab samples. The diagnostic test is intended for use in clinical and hospital laboratories. BARDA continues to work with its industry partners to develop rapid diagnostic tests for COVID-19.

About the Company

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care. The company’s patented system enables healthcare professionals to access actionable, laboratory-quality results at the point-of-care with greater sensitivity and specificity than current infectious disease rapid immunoassay tests.

The U.S. Department of Health and Human Services (HHS) will partner with Qiagen LLC of Germantown, Maryland, to accelerate development of a diagnostic test for the 2019 novel coronavirus (SARS-CoV-2). This easy-to-use test can provide results in about one hour.

The Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response is providing technical assistance and $598,000 to accelerate the development of the QIAstat-Dx Respiratory SARS-CoV-2 Panel test. Qiagen will, under a costs share, provide the remaining funds for the development of this diagnostic test.

Qiagen will develop QIAstat-Dx RPS2, to be added to the QIAstat-Dx Respiratory Panel that is currently FDA-cleared to test for 21 respiratory pathogens. The test kit can differentiate the SARS-CoV-2 coronavirus from other serious respiratory infections in patients who may have similar symptoms in a single testing run. The device features easy-to-use molecular testing with novel workflows.

The COVID-19 test could be ready within weeks for Emergency Use Authorization (EUA) consideration by the U.S. Food and Drug Administration (FDA). As of March 18, 2020, Qiagen’s test kit obtained CE marking as an in vitro diagnostic (IVD) in the European Union and obtained approval in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

About the Company

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions. Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics).

The U.S. Department of Health and Human Services (HHS) is supporting the development of a novel coronavirus diagnostic test by DiaSorin Molecular, LLC of Cypress, California. DiaSorin received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 19 for their COVID-19 Direct kit. DiaSorin will begin shipping kits for immediate use in laboratories across the US this week.

The Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) provided technical assistance and $697,000 for the development of the Simplexa^TM COVID-19 Direct assay, a molecular test for qualitative identification of the novel coronavirus SARS-CoV-2 which causes COVID-19.

DiaSorin’s test will use a nasopharyngeal (back of the nose and throat) swab from patients and is designed for use with the company’s Simplexa^TM Direct technology, a diagnostic platform currently used for their influenza and Respiratory Syncytial Virus (RSV) tests that have been cleared by the FDA.

The COVID-19 test would run on DiaSorin’s LIAISON^® MDX instrument, which works in conjunction with LIAISON^® MDX Studio software not only in reference laboratories, but also in labs that are closer to the patient, such as hospital labs. This technology uses a sample-to-answer approach with minimal operator input, yielding results in about 90 minutes. Hundreds of the company’s diagnostic devices are in use in large commercial, hospital, and public health laboratories around the country.

About the Company

DiaSorin Molecular LLC manufactures and distributes innovative molecular diagnostic products for hospital and reference laboratories. The company’s products help laboratories consolidate their testing, streamline processes and increase efficiency. DiaSorin Molecular’s Simplexa^TM molecular diagnostic kits are designed for use on the company’s versatile LIAISON^® MDX platform.

HHS Seeks Abstract Submissions for 2019-nCoV Diagnostics Development

As part of the U.S. government's ongoing public health response to the 2019 novel coronavirus (2019-nCoV), the U.S. Department of Health and Human Services (HHS) today announced the opening of an Easy Broad Agency Announcement (EZ-BAA) for development of 2019-nCoV diagnostics and is now accepting abstract submissions for potential funding.

Under this EZ BAA, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, will review concise abstract submissions for development funding of 2019-nCoV molecular diagnostics. The diagnostics must utilize platforms already cleared by the U.S. Food and Drug Administration, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization (EUA) within 12 weeks of an award.

"Diagnostics in close proximity to the patient are essential to ensure appropriate, prompt care and to help curb the spread of infectious diseases such as 2019-nCoV," said BARDA Director Rick Bright, PhD. "The 2019-nCoV poses a serious global health challenge, and at BARDA we are working rapidly with our government and industry partners to accelerate development of medical products needed to help protect the health of the American people."

The EZ-BAA was created to provide a streamlined process through which BARDA and BARDA's Division of Research, Innovation, and Ventures (DRIVe) can review and accept applications for development funding of transformative products and technologies to protect Americans from health security threats. In response to the 2019-nCoV outbreak, it has been modified to support diagnostics products that fit the profile outlined above. The application process is both business-friendly and easy to follow.

Since its inception, BARDA DRIVe's EZ-BAA solicitation has averaged more than one abstract submission per day while active, with awards made in as few as 30 days. The EZ-BAA has helped transform the contracting process and provide innovators, entrepreneurs, and organizations with a simplified and rapid mechanism to partner with the U.S. government. BARDA will leverage this process to rapidly respond to the current outbreak that has been identified as a Public Health Emergency by the Secretary of HHS.

For additional details, see solicitation BAA-20-100-SOL-0002.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation's health security. To learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov, and for more on DRIVe, visit drive.hhs.gov.

Note: All HHS press releases, fact sheets and other news materials are available at https://www.hhs.gov/news.

Like HHS on Facebook, follow HHS on Twitter @HHSgov, and sign up for HHS Email Updates.

Last revised: February 5, 2020

BARDA DRIVe is pleased to announce a partnership with Rizlab Health of New Brunswick, New Jersey, to develop a transformative technology to help diagnose and differentiate viral or bacterial infections prior to symptom onset. . If successful, this device will help clinicians assess patients in their care while the patient is at home to determine the appropriateness of antibiotic or antiviral use by differentiating those suffering from a viral infection from those infected with bacteria. This technology will transform the way medicine is delivered particularly to enable greater speed, flexibility, and access to vulnerable populations. Elderly, pediatric, and immunocompromised individuals would know in advance if they have an impending bacterial infection.

RizLab Health, a spinout from Rutgers University, is developing a novel hand-held wireless health monitoring system that leverages its CytoTracker device. The Cytotracker is a pocket-size device that can perform complete blood counts (CBCs) from a drop of blood. This partnership will further develop the CytoTracker concept to enable patients suffering from cold symptoms to be assessed for the likelihood of a viral or bacterial infection.

The monitoring system proposed consists of a wireless, pocket-sized, complete blood count analyzer which measures and differentiates various cell types in the blood sample. A mobile phone application will collect CBC data, along with user symptom information from the patient, and use artificial intelligence to inform the patient of the likelihood of a bacterial vs. viral infection. The data then can be shared with their physician for improved diagnosis and appropriate treatment.

This research has the potential to pave the way for enhancing not only the diagnosis of colds and flu, but also to enhance monitoring of patients at home after release from the hospital for a myriad of conditions including sepsis.

This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing the spread of bacteria and viruses. Prompt attention to serious health issues can save lives and reduce overall healthcare costs. Innovative technologies hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

DRIVe catalyzes the development of innovative products and approaches to solve major health security challenges through transformative products and approaches. DRIVe is a division within BARDA (Biomedical Advanced Research and Development Authority), a part of the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services.

DRIVe and Rizlab Health are committed to a public-private partnership, with DRIVe contributing up to $741,000 of the total estimated $1,064,000 project cost. Rizlab will provide the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the ways BARDA partners with industry and entrepreneurs. We bring together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation’s health security.

About the Company (Provided by RizLab Health)

Rizlab Health, Inc. is a new company that was founded in late 2018 and is a spinout from Rutgers University New Brunswick, The State University of New Jersey. Rizlab is based in Princeton, NJ and is dedicated to building point-of-care diagnostics tools for improvement in patient care. The company’s key focus is to bring hematology analysis from bench to the patient’s fingertips.

BARDA DRIVe is pleased to announce a partnership with GE Research of Niskayuna, New York, and The Feinstein Institutes for Medical Research of Manhasset, New York, to detect pre-symptomatic exposure to viral or bacterial pathogens using ultrasound. As part of this program, members of the bioelectronic medicine team at GE Research and Feinstein will use an ultrasound stimulus to modulate a neuroimmune pathway, a process known as ultrasound neuromodulation. It is hoped that the response to the stimulus will activate easily detected responses and thus provide a more rapid assessment of exposure and pathways to appropriate treatments if patients are infected with either viral or bacterial pathogens presymptomatically.

The application of ultrasound neuromodulation in this program builds upon on-going Defense Advanced Research Projects Agency (DARPA) funded research to develop feedback controlled therapeutic ultrasound to stimulate organs, such as the liver and spleen, for treatment of conditions including rheumatoid arthritis and diabetes. DRIVe’s partnership will expand use of the GE technology to a diagnostic test. This project has the potential to pave the way for development of specific signatures that can identify incubating illness before symptoms ever appear.

This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing the spread of bacteria and viruses. Prompt attention to serious health issues can save lives and lower overall healthcare costs to both facilities and patients. Innovative technologies like wearable products also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

BARDA’s DRIVe (Division of Research, Innovation, and Ventures) catalyzes the development of innovative products and approaches, like the GE technology, that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

DRIVe and GE are committed to a public-private partnership, with DRIVe contributing up to $700,000 of the total estimated $1,019,617 project cost. GE will provide the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the ways BARDA partners with industry and entrepreneurs. We bring together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation’s health security.

Company Description (provided by GE)

GE Research is GE’s innovation powerhouse where research meets reality. With a team of 1,000+ scientific, engineering and marketing minds (600+ Ph. Ds), GE Research is working at the intersection of physics and markets, physical and digital technologies, and across a broad set of industries to deliver world-changing innovations and capabilities for our customers.

To advance the development of a test that may be able to diagnose sepsis in less than 10 minutes, the U.S Department of Health and Human Services (HHS) will partner with Cytovale of San Francisco.

Under the cost-sharing agreement, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide expertise and $3.4 million to develop design specifications for the system and potentially an additional $4.17 million over 2.5 years for additional work, including studies needed to pursue regulatory clearance through the U.S. Food and Drug Administration (FDA).

Cytovale’s system incorporates the latest developments in microfluidics, high-speed imaging, and machine learning to identify sepsis-specific biophysical signatures of immune cells from a small volume of blood. Most diagnostics focus on the molecular characteristics; instead, Cytovale’s system looks at biophysical properties of immune cells and measures the immune cell activity associated with body’s immune response.

“We need faster diagnostics to move the needle on sepsis and reduce its health burden in our country,” said BARDA Director, Rick Bright, Ph.D. “Like so many threats, speed of diagnosis is critical to improving outcomes of sepsis patients. Through this and other projects, our Solving Sepsis program continues to focus on catalyzing technology to address sepsis.”

Sepsis is a serious public health threat, killing approximately 270,000 Americans each year. The condition is the result of a dysregulated immune response to infection which causes serious tissue damage that may lead to organ failure and death. Sepsis could pose an even greater health security threat in a chemical, biological, radiological or nuclear emergency, or as a complication of an influenza pandemic or other emerging infectious disease outbreak.

The cost-sharing agreement announced today builds on work completed under a previous cost-sharing contract between Cytovale and BARDA’s Division of Research Innovation and Ventures (DRIVe). BARDA provided $749,000 under that agreement through an EZ-BAA, or easy broad agency announcement.

The BARDA DRIVe Solving Sepsis program is supporting development of several technologies that aim to increase our nation’s ability to respond to sepsis, including advanced development of sepsis diagnostics. DRIVe is also working closely with federal partners to address sepsis at every stage of patient care. These efforts are part of the HHS commitment to fully address sepsis as a medical emergency and potential disaster threat.

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 51 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA accepts proposals for the advanced development of medical countermeasures through the Broad Agency Announcement, BARDA-BAA-18-100-SOL-00003, at https://www.fbo.gov.

Learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov.

Identifying patients with sepsis in hospital emergency departments, intensive care units and other hospital settings could be done earlier with diagnostic tests based on machine-learning algorithms, and now the U.S. Department of Health and Human Services (HHS) will work with Beckman Coulter Diagnostics of Brea, California, to develop such tools.

To develop the machine-learning algorithm, the Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research Innovation and Ventures (DRIVe), part of the HHS Office of the Assistant Secretary for Preparedness and Response, will provide an initial $1.25 million under a cost-sharing contract with Beckman Coulter.

BARDA DRIVe could provide an additional $6.5 million over four years under the cost-sharing agreement to support advanced research and development, validation and regulatory approval of the novel algorithm-based diagnostic. Beckman Coulter will work with Dascena, Inc. of Oakland, California, to develop the algorithm.

“The ability to improve specificity for rapid detection of sepsis and expand this capability to all hospital units and the emergency department through use of electronic health record data and blood clinical chemistry will greatly change the field,” said BARDA Director Rick Bright, Ph.D. “With sepsis, every minute counts and is critical for a full recovery. We want to make sure we can identify sepsis in all patients as rapidly as possible.”

The digital diagnostic solution combines “wet” and “dry” data together in a predictive algorithm expected to accurately detect sepsis early and improve patient outcomes. Wet data includes information from laboratory tests; dry data includes electronic health record information. This solution builds on Beckman Coulter’s existing Early Sepsis Indicator which received FDA 510K clearance in April 2019 and integration with Dascena’s InSight predictive algorithm for sepsis.

Sepsis kills approximately 270,000 Americans each year. The condition results from a dysregulated immune response to infection and causes serious tissue damage that may lead to organ failure and death.

Sepsis represents a serious public health threat and could amplify many health security threats in a chemical, biological, radiological or nuclear emergency, or as a complication of influenza or other infectious diseases. Sepsis is difficult to diagnose due to the heterogeneity of the disease and the difficulty of predicting the progression from infection to sepsis.

This project is part of BARDA DRIVe’s Solving Sepsis program which aims to reduce the incidence, morbidity, mortality and cost associated with sepsis by taking a systems approach in key strategic areas for sepsis, which includes developing diagnostics that address sepsis earlier along the patient continuum of care.

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 51 BARDA-supported products have achieved regulatory approval, licensure or clearance. BARDA accepts proposals for the advanced development of medical countermeasures through the Broad Agency Announcement, BARDA-BAA-18-100-SOL-00003, at https://www.fbo.gov.

Learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, by visiting the HHS public health emergency website, www.phe.gov. For more information on partnering with BARDA on developing medical countermeasures, visit www.medicalcountermeasures.gov.

BARDA DRIVe is teaming up with the Rory Staunton Foundation for Sepsis Prevention to help combat maternal sepsis, one of the leading causes of pregnancy-related deaths in the United States and of particular concern in a public health emergency. The program will identify and analyze the risk factors associated with maternal sepsis, including the demographic characteristics, co-morbidities, and obstetric procedures that place some women at higher risk of developing sepsis that can arise from any infection.

Maternal sepsis can occur when a severe infection develops during pregnancy or immediately after childbirth. In a public health emergency, illnesses and injuries caused by chemical, biological, radiological, nuclear agents can lead to secondary infections that, in turn, result in sepsis, putting individuals who are pregnant or who have recently been pregnant at risk of maternal sepsis.

Through this partnership, the Rory Staunton Foundation for Sepsis Prevention will work in collaboration with the NY State Department of Health to develop and analyze a maternal sepsis dataset that will be made publicly available. This analysis will inform the development of high quality, evidence-based education and training on the early recognition, treatment and management of sepsis for patients and health care providers, helping save lives in a public health emergency. A series of audience-specific tools and materials designed to educate providers, patients, policymakers and other key stakeholders will be developed. Although initial launch of these materials will be in collaboration with NY State Department of Health, this model can be replicated and amplified in other states.

DRIVe (Division of Research, Innovation, and Ventures) catalyzes the development of innovative products and approaches that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Sepsis kills approximately 270,000 Americans each year. The condition is the result of a dysregulated immune response to infection which causes serious tissue damage that may lead to organ failure and death. Sepsis is a serious public health threat, but could pose an even greater health security threat in the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication of influenza or other infectious disease outbreak.

This Powered by DRIVe project is part of DRIVe’s Solving Sepsis portfolio. Solving Sepsis supports the development of transformational technologies, including preventive and mitigation measures to reduce sepsis incidence, morbidity and mortality. The goal is to drive innovation and develop technologies and approaches that will enhance the nation’s ability to protect Americans from 21st century health security threats.

DRIVe and The Rory Staunton Foundation are committed to a public-private partnership, with DRIVe contributing $254,662 of the total $374,776 estimated project cost. The Foundation will fund the remaining costs.

DRIVe is transforming the speed in which BARDA partners with industry and entrepreneurs. To streamline its funding mechanism, DRIVe implemented a new EZ-BAA application, a business-friendly simple abstract.

Company Description (provided by the Rory Staunton Foundation for Sepsis Prevention)

The Rory Staunton Foundation for Sepsis Prevention was established following the preventable death of 12-year-old Rory Staunton from sepsis. As one of the leading sepsis organizations in the United States, the Foundation works to end the hundreds of thousands of preventable deaths and devastating disabilities caused by sepsis each year and to support those affected by the condition. Through its education and awareness programs, the Foundation increases understanding of the dangers and signs of sepsis, promotes rapid treatment, and encourages self-advocacy in the medical environment. The Foundation actively supports the establishment of mandatory sepsis protocols in each state to ensure rapid diagnosis and treatment of sepsis in hospitals and other medical settings.

BARDA DRIVe is partnering with Seattle-based 98point6 to leverage its on-demand primary care smartphone application, connecting patients nationwide to doctors, each of which is board-certified in all 50 states and DC in order to provide real-time respiratory and influenza diagnosis leveraging AI and machine learning assisted doctor evaluations of patients.

Through the DRIVe partnership, 98point6 will develop a robust, real-time respiratory disease-reporting technology; integration of data, application and devices, and a comprehensive program for prevention, treatment, social distancing of influenza and respiratory illness, during influenza season. 98point6 will deploy a pilot treatment program for registered users in the Greater Seattle area for antivirals to be delivered to patients at home within a few hours.

BARDA DRIVe (Division of Research, Innovation, and Ventures) catalyzes the development of innovative products and approaches, like the 98point6 technology, that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing the spread of bacteria and viruses. Prompt attention to serious health issues can save lives. Innovative technologies like this novel smart phone interface product also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

DRIVe and 98point6 are committed to a public-private partnership, with DRIVe contributing $257,670 of the total $368,100 project cost. 98point6 will provide the remaining development costs. DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the way BARDA partners with industry and entrepreneurs.

Company Description (Provided by 98point6)

Founded in 2015, 98point6 is headquartered in Seattle. By pairing deep technology with board-certified physicians, the vision of 98point6 is to make primary care more accessible and affordable—leading to better health and reducing the cost of care. 98point6 meets consumers where they are by offering private, text-based diagnosis and treatment via a mobile app.

BARDA DRIVe is pleased to announce a partnership with Sound Life Sciences (SLS) of Seattle, Washington. The startup company will deploy a contactless motion and respiratory monitoring technology in smart speakers in a cohort of patients with chronic obstructive pulmonary disease (COPD) to identify early illness onset during the influenza season. Individuals with chronic illnesses such as COPD are at increased risk for developing severe respiratory infections and novel ways to detect exposure early can improve treatment and outcomes. The smart speakers can be positioned up to about 2 meters away and monitor individuals while they sleep. Significant changes from baseline breathing patterns result in smartphone or telehealth notifications.

This smart speaker is designed to monitor breathing at frequencies that people do not hear and which does not harm pets. By using SLS’s technology, respiratory changes - which could serve as an early indicator of acute respiratory infection - could be detected earlier. This project has the potential to result in a low cost means of detecting respiratory illness using commodity devices already present in over 90 million homes.

DRIVe (Division of Research, Innovation, and Ventures) catalyzes the development of innovative products and approaches that aim to solve major health security challenges. DRIVe is a division of BARDA, part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing the spread of infections. Prompt attention to serious health issues can save lives. Innovative technologies like wearable products also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives. DRIVe and Sound Life Sciences are committed to a public-private partnership, with DRIVe contributing $746,815 of the total estimated $1,066,880 project cost. Sound Life Sciences will provide the remaining development costs.

BARDA DRIVe was launched in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the ways BARDA partners with industry and entrepreneurs.

Company Description (provided by Sound Life Sciences)

Sound Life Sciences is an early stage digital therapeutics company that builds clinically validated software for mobile phones and smart speakers. Their software converts a smart device into a short-range active sonar system that emits an inaudible high frequency sound that reflects off of the user’s chest and is analyzed by proprietary algorithms to identify respiratory patterns. This innovative technology enables contactless home respiratory monitoring using existing hardware, which could benefit millions of people with chronic medical conditions who are at risk for respiratory infection.

Five accelerators will join a unique innovation accelerator network that provides small and start-up biotechnology innovators with technical and entrepreneurial support they need to accelerate the development of products that could transform the nation’s approach to health security threats. The network was established by the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, in 2018 with eight accelerators.

The new accelerators expand the existing network, providing geographic coverage into areas of the country previously under-represented in the network. The five recently selected accelerators are:

• Emory University & Georgia Institute of Technology (Coulter Translational Program) in Atlanta, Georgia;
• Plug and Play Tech Center in San Francisco;
• University of Missouri Midwest BioAccelerator (MU-MBAr) in Columbia, Missouri;
• University Enterprise Labs in partnership with gener8tor in St. Paul-Minneapolis; and
• Purdue University in West Lafayette, Indiana.

“In the first year, our accelerator network reached audiences outside of normal government channels, fostering innovative solutions to improve national health security and to provide business expertise and laboratory space for startups and small businesses,” said Rick Bright, Ph.D., deputy assistant secretary for preparedness and response and director of BARDA. “By expanding the network into new geographic locations, we will connect with even more companies and entrepreneurs to solve systemic health challenges. The network is helping to revolutionize the way we do business and catalyze innovation across the country.”

To build a pipeline of products for BARDA’s Division of Research, Innovation and Ventures, these accelerators identify innovative products and solutions developed by entrepreneurs, innovators, start-ups, and academics around the United States to meet biodefense and other health security needs, and then provide these innovators with business and other services, such as regulatory support. Accelerators also introduce innovators to BARDA solicitations for funding consideration.

Currently, accelerators focus on sourcing products or solutions in three areas of interest to BARDA’s Division of Research, Innovation and Ventures:

• Early Notification to Act, Control, and Treat (ENACT), which funds technologies and platforms that provide early, actionable information to detect illnesses before people even know they are sick;
• the Solving Sepsis initiative, which focuses on reducing the incidence, morbidity, mortality and cost of sepsis; and
• other disruptive innovations, which seeks radically novel technologies that can transform health security.

The accelerator network began with eight accelerators located in regional hubs across the country where health security products and technologies in biotechnology, life science research, and medical innovations are heavily concentrated. These foundational accelerators are:

• The Center for Biotechnology at Stonybrook in Long Island, New York;
• First Flight Venture Center in Raleigh, North Carolina;
• Life Science Washington Institute in Seattle;
• MedTech Innovator in Los Angeles;
• Massachusetts Medical Device Development Center at UMass in Lowell, Massachusetts;
• New Orleans BioInnovation Center in New Orleans;
• Texas Medical Center Innovation Institute in Houston; and
• University City Science Center in Philadelphia.

BARDA DRIVe is pleased to announce a partnership with Sonica Health of Evanston, IL to assess cardiopulmonary health. Sonica’s bio-integrated, wireless sensor technology comprises a thin, soft, electronic system that gently adheres to the skin.

The advanced acoustomechanic (ADAM) system builds on previous translational R&D out of the John Rogers Research Group and the Center of Bio-Integrated Electronic at Northwestern University. This platform technology already has been deployed and tested in a wide range of medical applications and indications including pediatrics, sleep medicine, stroke rehabilitation, and gerontology.

Commercialized through Sonica Health, ADAM sensors will be adapted to offer 7-day battery life and a new, user-centric mobile application. A clinical study will examine user compliance and establish ADAM’s ability to identify early respiratory infections in a high-risk clinical population. With DRIVe support, Sonica Heath will assess ADAM’s full suite of respiratory digital biomarkers and ability to predict impending respiratory infection, warn of continued infectiousness, and identify treatment non-responders.

DRIVe (Division of Research, Innovation, and Ventures) catalyzes the development of innovative products and approaches, like the Sonica Health technology, that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing the spread of bacteria and viruses. Prompt attention to serious health issues can save lives. Innovative technologies like wearable products also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

DRIVe and Sonica Health are committed to a public-private partnership, with DRIVe contributing up to $656,420 of the total estimated $979,030 project cost. Sonica Health will provide the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the way BARDA partners with industry and entrepreneurs.

Company Description (provided by Sonica Health)

Sonica Health is a digital medicine company commercializing a breakthrough, body-integrated sensor technology for respiratory health.

BARDA DRIVe is teaming up with Inflammatix, Inc. to advance development of a host-response-based diagnostic (HostDx™-Sepsis) that can assess patients suspected of sepsis, separately determining presence of an infection as bacterial or viral and 30-day risk stratifying, to predict sepsis outcome.

Sepsis is notoriously difficult to identify as the symptoms are common to several other illnesses. Having a diagnostic that can accurately diagnose sepsis can save lives and help facilitate appropriate treatment intervention. Inflammatix has developed machine learning algorithms that examine a locked 29-mRNA signature from whole blood and can inform on whether an infection is present and its source as bacterial or viral. This distinction is important as it allows clinicians to start the appropriate treatment as well as support appropriate use of antibiotics. Inflammatix’s HostDx-Sepsis will also simultaneously output a risk stratification score to help determine whether a patient has or will develop sepsis and to guide clinical management and intervention.

Under this award, the HostDx Sepsis test will be implemented on the NanoString® nCounter® platform to assess potential applicability of the multi-RNA panel for the diagnosis of acute infections and sepsis in a clinical study of surgical ICU patients in which test results will be used to guide patient care.

DRIVe (Division of Research, Innovation, and Ventures) catalyzes the development of innovative products and approaches, like the Inflammatix technology, that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Sepsis kills approximately 270,000 Americans each year, many of them in hospital settings. The disease occurs when the body produces a dysregulated immune response to infection and causes serious tissue damage that may lead to organ failure and death. Sepsis is currently a serious public health threat, but could pose an even greater health security threat in the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication of influenza or other infectious diseases.

This Powered by DRIVe project is part of DRIVe’s Solving Sepsis portfolio. Solving Sepsis supports the development of transformational technologies, including preventive and mitigation measures to reduce sepsis incidence, morbidity and mortality. The goal is to drive innovation and develop technologies and approaches that will enhance the nation’s ability to protect Americans from 21st century health security threats.

DRIVe and Inflammatix are committed to a public-private partnership, with DRIVe contributing $749,000 of the total $2,114,410 estimated project cost. Inflammatix will fund the remaining development costs.

DRIVe is transforming the speed in which BARDA partners with industry and entrepreneurs. To streamline its funding mechanism, DRIVe implemented a new EZ-BAA application, a business-friendly simple abstract.

Company Description (provided by Inflammatix)

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in 20-30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford-StartX Fund and Think.Health Ventures.

BARDA DRIVe is pleased to announce it is partnering with UC San Diego to develop a miniaturized Vagus Sentinel, Magnetometer (VS-M), a low-profile wearable that can provide continuous monitoring without need for consumables. VS-M will be developed to detect pathogen-specific, localized infections before symptoms emerge, thus improving situational awareness and potentially preventing a pandemic.

The DRIVe research will provide the ability to conduct preliminary testing and development to monitor vagus nerve firing as a way to monitor changes to the immune system which would potentially enable pre-symptomatic detection of infection. In addition, Dr. Imanuel Lerman will lead a team at UC San Diego with the support of Qualcomm Institute to continue fabrication and miniaturization activities and create a form factor device suitable for everyday use.

The goal of the DRIVe partnership is to leverage the UC San Diego vagal device to allow individuals to detect pre-symptomatic infections against a variety of pathogens. Eventually such a technology could provide real-time information to public health and emergency responders of pathogen spread and allow them to provide timely prophylactic and preventative treatment, thus improving situational awareness and quenching the pandemic curve.

BARDA DRIVe supports the development of innovative products and approaches, like UC San Diego’s VS-M, that aim to solve major health security challenges. DRIVe is a division of BARDA, part of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT aim to empower Americans by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing progression of disease and onward transmission of pathogens. Prompt attention to serious health issues can save lives. Innovative technologies like this novel product also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

DRIVe and UC San Diego are committed to a public-private partnership, with DRIVe contributing $557,340 of the total $ 796,200 project cost. UC San Diego will provide the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the way BARDA partners with industry.

BARDA DRIVe is pleased to announce a partnership with Evidation Health of San Mateo, California, to leverage de-identified, patient-generated health data from everyday devices, available off the shelf, with population-based computer models that could improve “real time” influenza incidence prediction and enhance current disease surveillance systems to detect respiratory infections prior to the onset of symptoms.

The project builds on Evidation’s previous research, which found a statistical change in behavior and sleep patterns preceding the onset of influenza symptoms and lasting up to seven days after symptoms have resolved. DRIVe funding will leverage a clinical cohort of volunteers being monitored for respiratory infections using molecular and antibody-based tests that will generate clinical-grade data to verify and corroborate the signals generated by the algorithms. This project has the potential to pave the way for an extensive clinical trial that will enable Americans to monitor their respiratory disease symptoms and take precautions against spread of such diseases--days before symptoms appear.

BARDA DRIVe supports the development of innovative products and approaches that aim to solve major health security challenges. DRIVe is a division of BARDA, part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing the spread of bacteria and viruses. Prompt attention to serious health issues can save lives. Innovative technologies like wearable products also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

DRIVe and Evidation are committed to a public-private partnership, with DRIVe contributing up to $749,898 of the total estimated $1,335,648 project cost. Evidation will provide the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the ways BARDA partners with industry.

Company Description (provided by Evidation)

Evidation Health is a new kind of health and measurement company that provides biopharma and health care companies technology and guidance to understand how everyday behavior and health interact.

BARDA DRIVe seeks to expand our network of innovation accelerators into new areas of the country to support new product development to improve National Health Security. Read more about the opportunity and review Funding Opportunity Number EP-IDS-19-003.

Biomedical Advanced Research and Development Authority (BARDA) and its Division of Research, Innovation, and Ventures (DRIVe) is partnering with Janus-I Science, Inc., of Vista, California, to develop a diagnostic assay that is capable of identifying unknown infectious disease pathogens in patient specimens. This transformative technology has the potential to provide test results within an hour, enabling clinicians to know exactly what disease pathogens have infected their patients and how their bodies are responding to the infection.

Janus-I Science will develop a sample-to-answer workflow that uses nanopore sequencing to accurately identify unknown pathogens in patient specimens, and importantly, would be available for use right where patients need it for fast answers. Integrating the steps involved will simplify the workflow of sequencing-based diagnostics and provide faster, actionable results.

The project leverages Janus-I Science’s end-to-end sample preparation techniques with nanopore sequencing and computational data analytics. Janus-I Science will integrate and automate the entire process, which includes analysis and interpretation of sequencing data to provide clear, actionable results for use in a healthcare setting where the information is needed. For this project, Janus-I Science is partnering with Oxford Nanopore Technologies in the UK and the Naval Health Research Center in San Diego to build the assay workflow and demonstrate its accuracy using real-world specimens.

BARDA DRIVe supports the development of innovative products and approaches, like Janus-I Science’s diagnostic assay that aim to solve major health security challenges through innovative products and approaches. DRIVe is a division of BARDA and is part of the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services.

This Powered by DRIVe project is part of DRIVe’s portfolio for radically transformative health security technologies. DRIVe is seeking bold and disruptive innovative solutions that have the ability to transform health security. Relevant projects in this portfolio may create entirely new technologies, or leverage existing technologies in a way that represent a dramatic improvement to existing approaches.

DRIVe and Janus-I Science, Inc. are committed to a public-private partnership, with DRIVe contributing $710,619 of the total $1,015,179 estimated project cost. Janus-I Science will fund the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the way government partners with industry.

Company Description (Provided by Janus-I Science Inc.)

Janus-I Science Inc. combines new analytical technologies with advances in biology and algorithmic learning to create high value assays for healthcare, biosecurity, intelligence and other national security needs. Janus-I Science’s processes are designed to be implemented on multiple automation platforms, including high throughput laboratory, near patient or field-forward systems. Leveraging over 100 years of combined experience in the biotechnology, diagnostics and drug discovery industries, the scientific leadership team have developed advanced technologies for multiple government agencies and global health organizations. Janus-I Science is committed to delivering enabling new technologies to support the missions of our government partners and will commercialize them in collaboration with industry-leading therapeutic, diagnostic and research product companies.

Biomedical Advanced Research and Development Authority (BARDA) and its Division of Research, Innovation, and Ventures (DRIVe) is partnering with Enesi Pharma, of Oxford, UK, to develop a transformative vaccine administrative technology. The ImplaVax® formulation and needle-free system enables solid dose implants containing vaccines to be delivered quickly and painlessly under the skin with ease. The vision of this technology would be for healthcare providers or potentially even for individuals themselves to administer vaccines using this simple, convenient and reusable needle-free device.

This public-private partnership aims to develop a cost-effective technological innovation to improve vaccination uptake, coverage, and rapid vaccine response to pandemic influenza and other emerging infectious diseases. For the pilot, Enesi will leverage its ImplaVax® platform, combining a known influenza vaccine with a needle-free vaccine delivery system, to test the vaccine’s immunogenicity, thermal stability and rapid administration. ImplaVax® could become a potentially disruptive technology not only for influenza, but also for a range of infectious diseases and biological threats.

This project will involve analytical and pre-clinical evaluation of novel ImplaVax®-enabled solid dose implant formulations of known influenza vaccines in standard animal models. In-vitro tests will include evaluation of mechanical strength and surety of implantation. In-vivo testing will assess comparative immunogenicity and dosing regimens. Performance of solid dose implants versus placebo and active control vaccine delivered by needle and syringe will also be measured. The overall aim is to generate evidence to support the further evaluation of solid dose presentations as a potential alternative method of vaccination in a future pandemic response.

DRIVe supports the development of innovative products and approaches to solve major health security challenges through transformative technologies and approaches. DRIVe is a division within BARDA and is part of the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services.

BARDA and Enesi are committed to a public-private partnership, with BARDA DRIVe contributing $689,863 of the total $984,090 estimated project cost. Enesi will fund the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ BAA application process streamlines the way government partners with industry.

Company Description (Provided by Enesi)

The BARDA DRIVe team is pleased to announce that the new, easy-to-use EZ BAA online Portal is now live. This Portal will replace our existing PDF-based process, helping to improve the user experience, data integrity, and data security. The system will also streamline internal processes, helping DRIVe’s program teams continue to make awards in as few as 30 days.

DRIVe encourages all qualified parties to submit EZ BAA abstracts via the Portal. However, during this transition period, the DRIVe team recognizes that some organizations may have begun drafting abstracts using the PDF form. To accommodate those organizations, DRIVe will continue to accept PDF forms sent to DRIVeContracting@hhs.gov until May 8th, 2019. After May 8th all abstract submissions must come via the Portal.

All of the data requested for abstract submission remains the same as the current process. First, you need to request a Portal Account, which will generally be granted within 1-3 business days. Then you will logon to the Portal and complete the requested information, including the technical and cost components. No attachments will be necessary or allowed. After submitting the abstract, you will receive an automated email confirmation. DRIVe program managers and subject-matter experts will then review the submission and notify you of the decision. You will be able to simply log back on to the system should you wish to submit additional proposals or resubmit a modified abstract.

BARDA is excited to implement this system for submission of innovative projects to DRIVe. We believe it will significantly improve your submission experience as well as the review process. That said, we know that with any system there can be challenges in transition. Should you experience technical issues, our helpdesk is available 24/7 by calling 800-334-8571 (x26600). For other comments or concerns, feel free to email the DRIVe Webmaster.

BARDA DRIVe is pleased to release “Special Instructions” to Broad Agency Announcement (BAA) Sol #: BAA-18-100-SOL-00003; BARDA’s rolling BAA. The DRIVe Special Instructions are open now and will close on May 28, 2019. Medical product developers, research teams, and companies offering disruptive solutions to health security threats are invited to review the solicitation and prepare a white paper submission today. DRIVe is anticipating funding opportunities of up to $8 million, though projects may ultimately differ depending on agreement structure and availability of funds.

As part of our approach to make partnering with the government easier, DRIVe continues to work to streamline the application process, though the larger award value necessitates greater details than our successful EZ BAA program. We strongly recommend that you contact our ENACT or Solving Sepsis teams prior to submission to talk about your technology and proposed approach. Initial submission will include a DRIVe Special Instructions Submission Form, Quad Chart (1 page), White Paper (5 pages max), and Addendum (rough order of magnitude cost estimate, not to exceed 4 pages max). These will be reviewed by DRIVe, and select respondents will be invited to submit full proposals.

DRIVe is seeking the most innovative products and technologies to protect from the most serious systemic, natural, and international health security threats. Unlike the EZ BAA, this solicitation focusses on just two impact areas and is intended for specific targeted focus areas. We anticipate awards under these special instructions to be for more mature technologies, compared with EZ BAA submissions. Please note that our EZ BAA program remains active, and we encourage all potential respondents to consider the expedited EZ BAA abstract if your proposal is in early stages of development and would require a DRIVe investment under $749K.

In-scope priority areas fall into DRIVe’s current main impact areas: Solving Sepsis (Area of Interest #15) and Early Notification to Act, Control, and Treat (ENACT) (Area of Interest #16). Each impact area has specific focus areas. Solving Sepsis's focus areas are Advanced Research and Development of Sepsis Diagnostics and Devices and Post-sepsis Monitoring. ENACT’s focus area is On-person, Wearable, and Biosensing Devices (Host Response and Direct Pathogen Detection). For further details please refer to (Modification #08) the solicitation on FedBizOpps.

DRIVe Special Instructions for BAA Stage 1 Submission Process:

1. Request meeting with the ENACT or Solving Sepsis team (strongly recommended)
2. Submit stage 1 package to DRIVeContracting@hhs.gov. This package should include:

• Email subject: “DRIVe Special Instructions: Area of Interest_Company Name_Project Title”, where Area of Interest, Company Name, and Project title are replaced as appropriate.
• DRIVe Special Instructions Submission Form
• Quad Chart
• White Paper
• Addendum (ROM)

The BARDA DRIVe Solving Sepsis initiative is partnering with Qvella Corporation of Carlsbad, California, to develop ground-breaking technology to diagnose infection in patients suspected of sepsis with assay results in 60 minutes. The new host response diagnostic system leverages Qvella’s FAST-ID™ pathogen identification platform based on revolutionary new approaches to rapid sample processing and nucleic acid isolation and amplification directly from whole blood.

The ability to diagnose underlying infection and septic patients rapidly and accurately is a critical factor in saving lives, improving patient outcomes and making better use of healthcare resources. Sepsis is a serious public health threat, killing an estimated 270,000 Americans each year and incurring high healthcare costs. Sepsis would pose an even greater health security threat in the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication of influenza or other infectious diseases.

Sepsis occurs when the body’s efforts to fight an infection results in a dysregulated immune response and inflammation that can cause tissue damage, organ failure and death. Sepsis is difficult to diagnose and distinguish from other inflammatory conditions and currently can take days to accurately diagnose.

The Qvella project combines the company’s diagnostics technology and expertise with Predigen Inc.’s gene signature analytical power to help develop the intended assay for the early diagnosis of sepsis.

DRIVe (Division of Research, Innovation, and Ventures) supports the development of innovative products and approaches that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority) within the U.S. Department of Health and Human Services.

DRIVe and Qvella are committed to a public-private partnership, with DRIVe contributing $692,236 of the total $988,909 estimated project cost. Qvella will fund the remaining development costs.

DRIVe is transforming the speed in which government partners with industry. To streamline its funding mechanism, DRIVe implemented a new EZ-BAA application, a business-friendly simple abstract.

Company Description (provided by Qvella)

Qvella is a molecular diagnostics company founded in 2009 by a group of scientists and engineers with the goal of dramatically reducing time to results in bacteriology. The company aims to revolutionize how sepsis management is practiced by significantly cutting costs and saving lives. Qvella's Field Activated Sample Treatment (FAST) technology utilizes a novel sample prep technique that enables rapid detection of infectious agents and host response biomarkers from whole blood. When implemented in concert with Antibiotic Stewardship programs, now being adopted by most major medical centers, timely clinical decisions can be made which lead to improved patient outcomes, reduced hospital stays, lower side effect profiles, and a significant reduction in treatment costs.

Company Description (provided by Predigen)

Predigen, Inc. develops host gene expression signatures for use as prognostic, diagnostic, and therapeutic monitoring tools. Predigen is devoted to advancing the diagnostics field in areas of high unmet need, including infectious disease, cardiovascular disease, autoimmune and inflammatory disease, cancer and drug response.

BARDA DRIVe is pleased to announce it is partnering with Empatica of Cambridge, Massachusetts, to apply Empatica's wearable biomonitoring device toward DRIVe goals of predicting respiratory infections and exposures before any symptoms present.

The project builds on Empatica’s Embrace2, a battery-powered wristband FDA-cleared as a medical device for use by people suffering from epilepsy. Embrace2 technology measures multiple indicators related to physiological parameters. Embrace has also been approved in Europe as a medical device to monitor seizures and alert since April 2017. Currently Embrace2 uses advanced machine learning to monitor physiological parameters, detect unusual patterns that may be associated with convulsive seizures, and immediately notify users and caregivers.

This Powered by DRIVe product is now part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. ENACT aims to empower people by letting them know they are sick before the first symptom appears, encouraging early treatment and potentially reducing the spread of bacteria and viruses. Prompt attention to serious health issues can save lives. Innovative technologies like wearable products also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

The Empatica device will be among those tested in the upcoming DARPA/BARDA Prometheus Influenza In-the-Home Clinical Studies to evaluate health signatures that can predict pathogen exposures prior to symptoms.

DRIVe and Empatica are committed to a public-private partnership, with DRIVe contributing $251,454 of the total $457,189 project cost. Empatica will provide the remaining development costs.

DRIVe was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the ways government partners with industry.

Company Description (provided by Empatica)

Empatica Inc. is an MIT Media Lab Spin off that develops wearable smartbands that utilize machine learning and an intricate combination of biosensors to unlock the physiology of your health. Their Embrace smartband is the first FDA-cleared, wrist-worn wearable to be cleared in the field of epilepsy for its seizure monitoring and alerting capabilities. Embrace detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers; these signals include electrodermal activity, rotational speed, skin temperature, and high sensitivity motion detection.

The DRIVe Solving Sepsis initiative has partnered with Immunexpress of Seattle, Washington, to develop ground-breaking technology that analyzes a patient’s immune system to diagnose sepsis rapidly, within 90 minutes. Immunexpress SeptiCyte™ technology is a precision diagnostic tool that evaluates a set of patented gene-expression biomarkers from the patient’s blood. The tool is being designed to use mathematical algorithms to differentiate sepsis and infection negative systemic inflammation and identify whether the sepsis infection is viral or bacterial.

The ability to diagnose sepsis rapidly and accurately can facilitate faster, appropriate medical intervention, which is a critical factor in saving lives, improving patient outcomes and making better use of hospital facilities.

Sepsis kills some 270,000 Americans each year and, according to the HHS Agency for Health Care Policy and Research, is the most expensive hospital condition to treat. Sepsis occurs when the body’s efforts to fight an infection result in a dysregulated immune response and inflammation that can cause serious tissue damage, organ failure and death. Sepsis is difficult to diagnose and distinguish from other inflammatory conditions and can take days to diagnose accurately, therefore impacting clinical decisions.

Sepsis is currently a serious public health threat, but it could pose an even greater health security threat in the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication of influenza or other infectious diseases.

DRIVe (Division of Research, Innovation, and Ventures) supports the development of innovative products and approaches, like the Immunexpress technology, that aim to solve major health security challenges through innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.

DRIVe and Immunexpress are committed to a public-private partnership, with DRIVe contributing $744,739 of the total $3.2 million estimated project cost, and Immunexpress funding the remaining development costs. Immunexpress will leverage its prior experience of developing its FDA-cleared product (SeptiCyte™ LAB) to develop this new sepsis diagnostic on the Biocartis Idylla™ platform.

DRIVe is transforming the speed in which government partners with industry. To streamline its funding mechanism, DRIVe implemented a new EZ-BAA application, a business-friendly simple abstract.

About Immunexpress

Immunexpress is a Seattle-based molecular diagnostic company committed to improving outcomes for patients suspected of sepsis. Immunexpress’ SeptiCyte™ technology rapidly quantifies, directly from whole blood, specific molecular RNA biomarkers from the patient's own immune system – the ‘host response’. SeptiCyte™ LAB, recently cleared by the FDA, is the first of its kind in using the host immune system to differentiate systemic inflammatory response syndrome (SIRS) and sepsis. Detecting the host’s response to infection has the potential to differentiate infection earlier, faster and more accurately than finding the invading pathogen because it is independent of whether or not the pathogen is present in the sample. Immunexpress’ pipeline includes several sample-to-answer assays for near-patient testing. For more information visit www.immunexpress.com. Follow Immunexpress on Twitter and LinkedIn.

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To educate healthcare providers on recognizing the signs of sepsis across the continuum of care, DRIVe and Sepsis Alliance, one of the nation’s leading sepsis organizations, launched a sepsis education and training initiative called the Sepsis Institute.

The Sepsis Institute will provide high quality, evidence-based education and training on the recognition, treatment and management of sepsis to healthcare professionals. The Institute will develop and house new webinars and training modules created for a range of healthcare providers including primary care and urgent care practitioners, nursing staff and emergency medical services personnel.

BARDA seeks to empower the healthcare professionals who are on the frontlines during a national health crisis to save lives, and in that effort early identification and prompt treatment of sepsis will be critical. Recognizing the earliest signs of sepsis is particularly challenging because many of the symptoms are shared with common infections.

According to the Sepsis Alliance, sepsis is being increasingly recognized as a medical emergency, a leading cause of death and a major public health concern.

Sepsis kills an estimated 270,000 Americans each year and occurs when the body’s overwhelming response to infection results in a dysregulated immune response that can cause serious tissue damage, organ failure and death. Sepsis is already a serious health issue, and in the event of a chemical, biological, radiological or nuclear attack or incident resulting in increased rates of infection, sepsis could pose an even greater health security threat.

DRIVe’s Solving Sepsis program supports the development of transformational technologies, including preventative and mitigation measures to reduce sepsis incidence, morbidity and mortality as well as economic burden. The program is part of DRIVe’s mission to support transformative innovation to protect Americans from 21st century health security threats.

DRIVe and Sepsis Alliance are committed to a establishing a public-non-profit organization partnership, with DRIVe contributing $427,248 of the total $622,248 estimated project cost to establish the Sepsis Institute and develop educational content. Sepsis Alliance will fund the remaining development costs.

About Sepsis Alliance

Sepsis Alliance is the leading sepsis organization in the U.S., with expertise in developing educational materials for professionals and for the public, reaching more than 3 million patients and providers each year. Sepsis Alliance is working in all 50 states to save lives and reduce suffering by raising awareness of sepsis as a medical emergency. In 2018, Sepsis Alliance launched It’s About TIME™ , a national initiative to create broader awareness of sepsis and the need for urgency in seeking treatment when there are signs and symptoms present.

In 2011, Sepsis Alliance designated September as Sepsis Awareness Month to bring healthcare professionals and community members together in the fight against sepsis. Sepsis Alliance gives a voice to the millions of people who have been touched by sepsis – to the survivors, and the friends and family members of those who have survived or who have died. Since 2007, sepsis awareness in the U.S. has risen from 19% to 65%. Sepsis Alliance is a GuideStar Gold Rated charity. For more information, please visit www.sepsis.org. Connect with us on Facebook and Twitter at @SepsisAlliance.

The BARDA DRIVe Solving Sepsis initiative is partnering with Emory University to further validate an interoperable machine learning software for early prediction of sepsis in hospital intensive care units that will provide physicians with actionable information. The project will leverage a multicenter consortium (Emory University School of Medicine, Massachusetts General Hospital, University of California San Diego School of Medicine, and Atlanta’s Grady Health System) for retrospective validation utilizing a secure cloud architecture and will also execute a prospective deployment of the real-time predictive algorithm.

DRIVe (Division of Research, Innovation, and Ventures) aims to achieve solutions to health security challenges through collaboration and supporting the development of innovative products and approaches. DRIVe is an initiative of BARDA (Biomedical Advanced Research and Development Authority), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.

The deep learning algorithm currently in use in the Emory Healthcare system processes high-resolution vital signs and laboratory measurements in real time to produce prediction scores and has the potential to warn health professionals of the impending development of sepsis in patients 4 to 6 hours in advance.

Leveraging the Google Cloud Healthcare API and the Google Cloud Platform, the Emory team will optimize the software platform and undertake a prospective cloud-based implementation study, for a multi-site evaluation and validation, with an eventual goal of seeking FDA clearance as software as a medical device (SaMD) for early prediction of sepsis. The device, which would allow for detection of early signs of sepsis and the corresponding leading causes via a deep learning-based multi-dimensional time-series analysis approach, could improve clinicians' situational awareness and potentially save lives.

Sepsis kills approximately 270,000 Americans each year, many of them in hospital settings. The disease occurs when the body’s overwhelming response to an infection produces a dysregulated immune response and causes serious tissue damage that may lead to organ failure and death. Sepsis is currently a serious public health threat, but could pose an even greater health security threat in the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication of influenza or other infectious diseases.

DRIVe and the research consortium will work in partnership, with DRIVe contributing $699,376 of the total $1.04 million estimated project cost. The consortium institutions will fund the remaining development costs.

DRIVe’s Solving Sepsis program supports the development of transformational technologies, including preventive and mitigation measures to reduce sepsis incidence, morbidity and mortality. The goal is to drive innovation and develop technologies and approaches that will enhance the nation’s ability to protect Americans from 21st century health security threats.

DRIVe is transforming the speed with which government partners with industry. To streamline its funding mechanism, DRIVe has implemented a new EZ-BAA application process.

About the Consortium

Drs. Shamim Nemati and Ashish Sharma from the Department of Biomedical Informatics at Emory University School of Medicine are leading the sepsis consortium in collaboration with Drs. Brandon Westover and Shawn Murphy at Massachusetts General Hospital, Drs. Lucila Ohno-Machado, Michael Hogarth, Christopher Longhurst, and Venktesh Ramnath at UC San Diego School of Medicine, and Drs. Andre Holder, Daniel Wu and Greg Martin from Emory University School of Medicine and the Grady Health System in Atlanta. The research team brings together in-depth expertise in Critical Care Medicine and Sepsis, Electronic Health Records (EHR) interoperability, Cloud Computing, Machine Learning and Artificial Intelligence.

About Emory University School of Medicine

Emory University School of Medicine is a leading institution for medical education, research, and patient care, with a diverse student body and a commitment to developing innovative leaders. The school has nearly 2,900 full- and part-time faculty, 556 medical students and 530 allied health students, 1,311 residents and fellows in 106 accredited programs, and 93 MD/PhD students. Faculty received $456.3 million in external research funding in fiscal year 2018.

http://med.emory.edu/index.html

DRIVe partners with Biobeat Technologies of Israel to develop a wearable monitoring device that diagnoses the flu and infections before any symptoms appear. The BARDA Division of Research, Innovation, and Ventures (DRIVe) is pleased to announce it is partnering with Biobeat Technologies Ltd. of Israel to develop a wearable early-warning device that monitors vital signs and alerts users they are getting sick before they feel symptoms. The project builds on Biobeat’s Wrist Watch, an FDA-cleared monitoring device that continuously measures blood pressure, heart rate, heart rate variability, oxygen saturation, respiratory rate, stroke volume, cardiac output and index, systemic vascular resistance, sweat, skin temperature, and more. With funding from DRIVe, Biobeat will further develop the technology to track bodily changes that signal the user has potentially been exposed to an influenza virus or other pathogen.

This Powered by DRIVe project is part of DRIVe’s Early Notification to Act, Control, and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are getting sick before the first symptom appears, encouraging early treatment of the disease and potentially reducing the spread of virus. Innovative technologies like wearable products also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

Biobeat’s technology is based on reflective photoplethysmography, a low-cost technique to detect blood volume changes in the smallest blood vessels of human tissue and often used non-invasively to make measurements at the skin surface. The data is recorded and analyzed to produce alerts and recommendations of clinical significance. This also potentially allows prediction and early warning before severe physiological emergencies occur. Information can be transmitted via the cloud to a cell phone application or data base. DRIVe and Biobeat are committed to a public-private partnership, with DRIVe contributing $599,000 of the total $954,800 project cost. Biobeat will provide the remaining development costs.

DRIVe, a division of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Assistant Secretary for Preparedness and Response (ASPR) was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the ways government partners with industry. This award was made in 85 days from submission to award. About Biobeat Technologies Ltd.

Biobeat is a technology company that has developed continuous, wireless, non-invasive, accurate medical-grade monitoring devices that measure and record vital signs and other physiologically relevant parameters. The Biobeat sensor platform can detect and monitor physiological parameters regarded as markers for health status. This could be used to identify those who are pre-exposed, pre-symptomatic; post-exposed, pre-symptomatic; and/or post-exposed, symptomatic and asymptomatic. Moreover, combining these parameters with laboratory results could help validate and predict symptom onset. Another aim would be to monitor close contacts of individuals diagnosed as having flu, follow their health, and look for signs of infection among them, thus allowing us to understand the natural history of flu infection, validated by the use of multiple parameter analysis, supported by blood tests conducted during the study to identify flu or other infectious agents. For more information visit http://www.biobeat.cloud/.

DRIVe is pleased to announce it is partnering with Cytovale, Inc. of San Francisco to develop new technology to diagnose sepsis in under 10 minutes. Using a simple blood test, Cytovale’s technology is intended to measure physical changes in immune cells that occur when someone is sick to indicate whether a patient has sepsis.

Support for the project is part of DRIVe’s ambitious Solving Sepsis initiative to accelerate the development of products that have potential to revolutionize the way sepsis is diagnosed and treated.

Sepsis kills an estimated 270,000 Americans each year, with a health care cost of over $24 billion annually. Sepsis occurs when an infection or other insult to the body produces a dysregulated immune response in a patient, which can cause serious tissue damage, organ failure, and even death. The disease is difficult to diagnose, and with current laboratory testing, can take a long time - sometimes days - to confirm.

Cytovale’s low-cost diagnostic holds the potential to provide the quick information emergency room healthcare providers need in the critical first hours and days of this often-deadly disease.

The Cytovale technology takes advantage of advances in microfluidics, ultra-high speed imaging, computer vision, and machine learning to rapidly quantify immune cell dysregulation from a blood sample in minutes. It uses deformability cytometry to measure immune cell changes, like inflammation and other changes that occur when a person is getting sick.

DRIVe’s Solving Sepsis initiative supports innovative technologies to prevent and reduce sepsis incidence, morbidity, and mortality. Sepsis is already a major public health threat, and it could pose an even bigger health security threat in the event of a chemical, biological, radiological, or nuclear attack or incident, or as a complication from influenza or other infectious diseases.

DRIVe and Cytovale are committed to a public-private partnership, with DRIVe contributing $749,000 of the total $1.397 million project cost. Cytovale will cover the remaining development costs for this phase of development as a part of a cost share.

DRIVe is transforming the speed in which government partners with industry. To streamline funding, DRIVe implemented a new business-friendly EZ-BAA application process enabling this award to be made in less than two months (55 days from submission to award).

About Cytovale

Cytovale is a venture backed, clinical-stage medical diagnostics company developing a novel platform that rapidly interrogates thousands of single cells to quantify the mechanical signatures of disease. The company’s lead product is focused on early sepsis detection in the Emergency Department setting to dramatically improve patient outcomes and reduce healthcare costs. With promising data in multiple studies across hundreds of patients, the system is currently under development with FDA clearance studies planned in the near future. Cytovale’s investors include Breakout Ventures, Blackhorn Ventures & other major healthcare oriented technology investors. For more information contact info@cytovale.com or visit Cytovale.com.

The Biomedical Advanced Research and Development Authority (BARDA) within the Assistant Secretary of Preparedness and Response (ASPR) at Health and Human Services (HHS) is seeking to recruit an exceptionally talented and forward-looking leader to serve as Director of its Division of Research, Innovation, and Ventures (DRIVe). DRIVe was launched in June 2018 to transform health security and support ASPR’s mission to Save Lives and Protect Americans from 21st century health security threats by investing in disruptive innovation.

The DRIVe Director will provide vision and strategic direction to identify and accelerate the development and availability of transformational technology and medical countermeasures. BARDA is looking for a dynamic executive, to lead an extraordinary team of restless innovators and industry experts who are building a portfolio of innovative products that transform the way we prevent, detect and respond to major health security threats. The Director will establish investment priorities, strategies and build novel partnerships to drive innovation that will solve critical and complex health care challenges and strengthen our nation’s health security. Initial DRIVe areas of focus include "Solving Sepsis" to reduce morbidity and mortality associated with sepsis, and "Early Notification to Act, Control, and Treat" (ENACT), to identify infections and exposures before people know they are ill.

Candidates must have a Ph.D., M.D. or other earned doctorate and have significant specialized experience leading, directing, and managing an innovative and dynamic organization focused on the development or use of medical countermeasures (e.g. vaccines, drugs, diagnostics tools, medical devices) or technologies that address public health threats. The DRIVe Director position will be based in Washington, DC.

Applications for this position are welcome until November 30, 2018 December 7, 2018. The time is now to serve and help Save Lives and Protect Americans from 21st century health security threats. Take the first step today by clicking here to learn more about the job and submit an application.

DRIVe’s Solving Sepsis program is excited to partner with InnaMed of Philadelphia. InnaMed is developing a point-of-care rapid blood testing device to help diagnose sepsis, determine risk stratification of patients and monitor the response to treatments. DRIVe is providing funding to InnaMed to develop a promising biomarker associated with sepsis to be integrated into this portable device.

InnaMed will develop its proprietary electrochemical proximity assay (ECPA) technology to rapidly test blood for the sepsis-associated biomarker, a recently identified peptide that has shown increased sensitivity, specificity and prognostic ability compared to currently used sepsis indicators. The ECPA platform will be combined with analytics to determine a “sepsis score” to triage and monitor patients.

Solving Sepsis accelerates the development of transformational technologies, including preventative and mitigation measures to reduce sepsis incidence, morbidity and mortality.

Sepsis is the body’s dysregulated immune response to infection that can cause serious tissue damage, organ failure, and death. Sepsis kills more than 270,000 Americans each year but is often difficult to diagnose. In the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication from influenza or other infectious diseases, sepsis could occur as a secondary confounder and is therefore a major health security threat.

DRIVe and InnaMed are committed to a true public private partnership, with DRIVe contributing $200,000 of the $285,750 estimated project costs. InnaMed will fund the remaining development costs.

DRIVe is committed to transforming the speed in which government partners with industry. This contract was awarded within 30 days of InnaMed’s DRIVe EZ BAA Solving Sepsis application.

About InnaMed

InnaMed is developing a comprehensive care management platform. Using InnaMed's products, patients can perform painless blood tests to quantify established biomarkers, answer condition specific symptom surveys, and report vitals like BP, HR and weight. These high-resolution data streams are then combined to measure disease activity at the biological level, identify meaningful changes in status to alert care teams and guide changes in treatment strategy. Founded in 2016, InnaMed is focused on improving the management of complex chronic conditions. The company is headquartered in Philadelphia. www.InnaMed.com

The BARDA DRIVe Solving Sepsis program welcomes its first partner, Prenosis of Chicago, IL. Prenosis is developing analytic systems that may help doctors predict the progression of sepsis in a patient. With DRIVe funding, Prenosis will develop a precision-medicine technology that could transform the clinical management of sepsis.

Prenosis’ ImmunoMatch™ technology uses machine learning algorithms trained by its proprietary dataset (NOSIS) which combines critical biological information with existing electronic medical record data, to perform intelligent patient matching. With technology to predict how a sepsis patient’s condition will progress, doctors can determine more quickly what is needed to improve outcomes over the continuum of sepsis care.

Solving Sepsis supports development of transformational technologies, including preventative and mitigation measures to reduce sepsis incidence, morbidity and mortality.

Sepsis kills more than 270,000 Americans each year and occurs when the body’s overwhelming response to infection results in a dysregulated immune response that can cause serious tissue damage, organ failure and death. In the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication from influenza or other infectious diseases, sepsis could potentially occur as a secondary confounder, and therefore poses a major health security threat.

DRIVe and Prenosis are committed to a true public-private partnership, with DRIVe contributing $749,000 of the total $1.07 million estimated project cost. Prenosis will fund the remaining development costs.

DRIVe is transforming the speed in which government partners with industry. To streamline its funding mechanism, DRIVe implemented a new EZ-BAA application, a business friendly simple abstract. The contract with Prenosis was awarded within 30 days of its EZ-BAA application submission.

About Prenosis

Prenosis develops predictive analytics clinical decision support tools to improve sepsis care in hospitals. Prenosis’s ImmunoMatch technology partners with physicians to treat patients with confidence by enabling a precision medicine approach to sepsis that utilizes the proprietary NOSIS dataset, machine learning algorithms, and a point-of-care device. For more information, please visit www.prenosis.com or contact us at info@prenosis.com

DRIVe welcomes partner Spire, Inc. of San Francisco. DRIVe, a division of the Biomedical Advanced Research and Development Authority in the HHS Office of the Assistant Secretary for Preparedness and Response, is providing research and development funding for the new Spire Health Tag, a wearable early-warning sensor that measures the body’s heart rate, breathing patterns, and even stress levels, and with the potential to alert users that they are about to get sick.

Currently the Spire Health Tag is available for consumer health and wellness use, including to help monitor sleep, stress and activity. Now with funding for DRIVe, Spire will further develop the product, aiming for U.S. Food and Drug Administration (FDA) 510K clearance. FDA clearance is required to ensure medical devices are safe and effective before they can be marketed for clinical applications.

This Powered by DRIVe project is part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT empower people by letting them know they are sick before the first symptom.

The Spire Health Tag is a small washable device that attaches to clothing to monitor and report activity and detect changes in the body. The device can send messages to the user’s cell phone to report findings and alert the wearer to real-time bio-signals, like heart-rate and breathing variability, changes in body heat, stress levels, and other changes in the unique health signature of the user. It is designed to be easy to use, can be worn while the person sleeps, and does not need to be recharged.

Innovative technologies like wearable ENACT products hold the potential to also strengthen the nation’s ability to protect Americans from health security threats and to save lives.

Spire and DRIVe, as a true public private partnership, are sharing costs to increase the chances of success. The total project cost is $88,860, with the DRIVe contributing approximately $62,200 and Spire funding the remaining costs.

DRIVe is committed to transforming the speed with which government partners with industry. This award was made within a month of Spire’s DRIVe EZ BAA application!

About Spire

Spire is dedicated to giving every person the power to control their own mental and physical health by capturing real-time bio-signals and making data useful and actionable. Founded in 2013, Spire has become the recognized market-leader in continuous respiration sensing, real-time interventions, and actionable feedback. Spire is based in San Francisco and has backing from Rock Health, Stanford StartX, and other leading medical device investors. Learn more at spire.io

DRIVe welcomes its first partner, EnLiSense of Allen, Texas! DRIVe is providing research and development funding to accelerate development of a wearable device from EnLiSense that detects infections from a person’s sweat.

This Powered by DRIVe award provides non-dilutive funding for up to 18 months and is part of DRIVe’s laser-like focus on transforming health security. DRIVe invests in disruptive innovation to protect Americans against 21st century health security threats.

The first Powered by DRIVe project falls under DRIVe’s Early Notification to Act Control and Treat (ENACT) program. Products developed under ENACT empower people by letting them know they’re sick before they even feel sick.

EnLiSense’s non-invasive SWEATSENSER diagnostics (Dx) Platform could become an easy-to-use wearable sensor to quickly detect or rule out infections. The sensor, which may resemble a wrist-watch, works by detecting and tracking multiple biomarkers, including cytokine levels in sweat; these levels may be an early warning of changes in the body.

The SWEATSENSER could be used in a hospital setting or in the community to identify an influenza infection or other illness related to chemical, biological, radiological, or nuclear disasters.

Innovative technologies like the EnLiSense platform have the potential to strengthen our ability to protect Americans from health security threats and to save lives.

This EnLiSense and DRIVe announcement is a true public private partnership with DRIVe providing just over $550,900 and EnLiSense picking up a share of the cost.

DRIVe is committed to transforming the speed in which government partners with industry. This award was made within one month of EnLiSense’s DRIVe EZ BAA application!

About EnLiSense

Since 2014, EnLiSense is committed to developing Point-of-Need technologies and solutions for enhancing the quality of human life. EnLiSense’s technologies and solutions enable tracking of WELLNESS to ILLNESS and Back to WELLNESS states of users, allowing users and care-givers to make informed and reliable early decisions on their health and lifestyle choices. For additional information, visit https://enlisense.com/. Contact: PR@enlisense.com +1 (972) 736-7059

Timothy G. Buchman, MD has four decades of bedside experience caring for septic patients. He is Professor of Surgery, Anesthesiology, and Biomedical Informatics at Emory University, where he founded the Emory Critical Care Center. Dr. Buchman is past president of the Shock Society, of the Society for Complex Acute Illness and of the Society of Critical Care Medicine. He is Editor-in-Chief of Critical Care Medicine. He is also a member of the External Faculty of the Santa Fe Institute and has served as the Edison Professor of Surgery and Director of Acute and Critical Care Surgery at Washington University in St. Louis. He directed the Surgical Intensive Care Unit and founded the Adult Trauma Service at Johns Hopkins Hospital. Dr. Buchman is widely published in the field of sepsis.

Steven Q. Simpson, MD is a prominent medical researcher and expert in sepsis. He is Professor of Medicine and Interim Director of the Division of Pulmonary and Critical Care Medicine at the University of Kansas. He is past Chair of Interdisciplinary Critical Care at the University of Kansas Hospital and Medical Director of three intensive care units. Dr. Simpson is the Chief Medical Officer for Sepsis Alliance, the country’s largest charitable advocacy organization dedicated to battling and raising awareness about sepsis. He has conducted research in all areas of severe sepsis from molecular and cellular mechanisms, to translational studies, to quality improvement studies. Dr. Simpson is widely published in the field of sepsis.

DRIVe's new application process, called an EZ-BAA, is now open for business! Medical product developers, research teams and companies offering disruptive solutions to health security threats are invited to submit abstracts beginning today using this simplified EZ-BAA process.

We're looking for the most innovative products and technologies to protect Americans from the most serious systemic, natural and intentional health security threats. Our goal is to build a portfolio of products representing disruptive innovative approaches that will transform health security.

Applications accepted through this streamlined process must offer transformative innovation, products and technologies to protect Americans from health security threats. This application process is a business friendly simple abstract.

In-scope priority areas include products and solutions to reduce illness and death from sepsis as part of DRIVe's Solving Sepsis initiative; technologies and processes to identify infections and exposures to biological and other health threats, as outlined in the Early Notification to Act, Control, and Treat (ENACT) initiative; and tools and techniques to mitigate the damages and loss of life associated with catastrophic events.

Applying is simple:
Download the application form.
Submit a technical abstract no longer than 2,000 words.
Submit a cost proposal of no more than 2,000 words.
Proposed costs should not exceed $749,000.

What happens next:
Once submitted, DRIVe's experts will review the application to ensure it's within scope and meets DRIVe criteria.
As the applicant, you'll be notified of the review results within 30 days of your submission.

Learn more about the DRIVe EZ-BAA review criteria.

Have questions? Looking more information? Contact DRIVeContracting@hhs.gov