Needle

Covid 19 at home diagostics

Rapid and widely available access to COVID-19
testing in the home setting.

OVERVIEW

With COVID-19 At-Home Diagnostics, DRIVe and BARDA’s Detection, Diagnostics, & Devices Infrastructure (DDDI) division are seeking disruptive platform technologies to serve as reliable alternatives to centralized laboratory testing. This program focuses on providing a suite of fast, accurate, and affordable diagnostic tools that individuals can use at home, reducing the need for travel, thereby reducing the potential for contagion.

PARTNERS

Companies we have partnered with on this program to date

APPROACH

To support the development and validation of novel pathogen sensing technologies for rapid, affordable, and highly accurate COVID-19 tests, this program is taking two approaches:

1

Supporting validation and EUA submission of mature technologies to accelerate market availability of tests,

2

Supporting development of transformational technologies that significantly advance the state of the art and enable future at-home testing capabilities.

Program Goals

The aim of the COVID-19 At Home Diagnostics program is to advance the field across multiple technology areas, including:

Development of tests that use noninvasive specimens

Sample to answer in less than 30 minutes

Entire test process performed at home

Development of small, easy-to-use devices

Novel assay reagents, formats/designs, and detection modalities that can provide superior sensitivity, and specificity, with shorter time to result

Innovative use of communication technology to assist in assay interpretation and HIPAA-compliant transmission of results

Completion of clinical trial and submission of EUA application to FDA within 6 months

Development of systems that are cheap enough to make them affordable to the average American and robust enough for home use

Needed

covid at home diagnostics

Funding
Opened

8/25/21

Special
Instructions

#14

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Revised description
and extended
deadline

1/7/22

Special
Instructions

#18

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Funding
Closed

4/29/22

Program Faq

Is this Funding Opportunity 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 the EZ-BAA and the special instructions.

Can large companies apply to this funding program?

Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov.

can companies/universities outside of the United States apply for DRIVe funding?

Yes. Applicants from outside of the United States are eligible to apply for funding.

Do academic institutions also need to provide a 30% cost share?

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.

What are the data sharing requirements of this program?

Projects funded under this program 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 use consistent with the regulation.

The EZ-BAA application is so short. Can I include links to figures or references?

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.

COVID at Home Diagnostics program is closed