DRIVe Funding Opportunity #10

NGS-based Agnostic Diagnostic


health data

About


An agnostic test to detect any respiratory RNA virus, including new and emerging viruses, that can be implemented rapidly and without the need for additional regulatory approvals in future pandemic situations.


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Overview

Next-generation sequencing diagnostics have been established for oncology and some genetic disorders, and such technology  is also needed for infectious diseases due to  health security threats.  In a viral outbreak or pandemic, having agnostic tests – which can detect any respiratory RNA virus and can be implemented rapidly without the need for additional regulatory approvals – is crucial.

NGS technology can detect and analyze viral genomes from any existing or emerging viruses in an unbiased manner compared to targeted polymerase chain reaction (PCR) and antigen assays. PCR and antigen assays require a significant effort to develop, verify, validate, as well as earn regulatory approval. In pandemic situations,  next-generation sequencing assays could provide the capability for agnostic detection ability, especially with emerging respiratory pathogens and can be used  on day one with appropriate regulatory approval. These tests also provide information  crucial to timely and actionable patient care.

Despite the promise of next-generation sequencing, the commercialization of such platforms has not yet occurred, and no U.S. Food and Drug Administration (FDA)-cleared agnostic diagnostic currently exists for use in pandemic situations.

Our focus is to further verify and validate the existing NGS-based assays for detection of respiratory RNA viruses, and support them through FDA approval. We expect that this approach will help to prepare the U.S. and potentially the world for future pandemics involving respiratory RNA pathogens. Expanding on this technology eventually could open up other opportunities for agnostic infectious disease diagnostics.



Program FAQ

Learn about our NGS-based Agnostic Diagnostics program by checking out our frequently asked questions




Is the NGS-based agnosic diagnostic open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in EZ-BAA.


Yes. Applicants from outside of the United States are eligible to apply for funding. Please note though that U.S.-based manufacturing of the proposed solution device/diagnostic will be prioritized.


Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50% minimum ,unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners under the DRIVe EZ-BAA have been awarded a contract that does not include a cost-share component below range, including all universities and non-profit organizations. Cost-share may be in-kind or cash contributions. It may also come from a third-party investor/sponsor, however, it is up to you to ensure you receive their contribution toward the proposed project. Many organizations offer to cover Overhead or Fringe Benefits. Some also offer pro-bono labor hours or sponsored equipment, materials, or subcontractor costs. A combination of all of the above could be acceptable. It would need to be indicated on a submission what is being cost-shared. To qualify for no cost-share under an EZ-BAA award, a respondent must show that there is "no probability that the respondent will receive present or future benefits from participation as described in Federal Acquisition Regulation (FAR) 16.303." Examples of present or future benefits include increased technical know-how, training for employees, acquisition of goods or services, development of a commercially viable product that can be sold in the commercial market, and use of background knowledge in future contracts.


NGS-based agnostic diagnostic projects have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government’s use consistent with the regulation.


While you can include links to figures or references, it is not mandated that reviewers view that outside information. At this time, the abstract format does not accept any figures, only text.




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For more information, please contact us at NGS@hhs.gov

Submit your EZ BAA Abstract