The U.S. Government program is now accepting submissions to develop diagnostics to detect SARS-CoV-2 acute infection as part of a new “COVID-19 At Home Diagnostics” program.
The Biomedical Advanced Research and Development Authority (BARDA) has opened a new area of interest under the EZ Broad Agency Announcement (EZ-BAA) solicitation to develop rapid and affordable home-based diagnostics to detect SARS-CoV-2 acute infection and supportive technologies which help enable more widespread, decentralized testing.
At-home diagnostics can empower individuals with better knowledge about their infection status, and ultimately reduce community transmission.
Through this opportunity, BARDA aims to advance the maturity of simpler tests that are inexpensive and easy to use. For more advanced tests, BARDA anticipates achievement of U.S. Food and Drug Administration (FDA) Emergency Use Authorization within six months. The ideal candidates would leverage existing manufacturing capabilities and be available to the public through the over-the-counter market.
BARDA is also seeking technologies that enable more convenient, widespread, and decentralized COVID-19 testing, or that improve on the current limitations of at-home diagnostic sensitivity, specificity and performance.
Early on during the pandemic, BARDA accepted applications through the EZ-BAA for COVID-19 antigen and molecular tests, which led to approximately 30 partnerships, 26 EUAs, and 140 million tests shipped. Reducing the barrier to testing is critical to equipping individuals with actionable health information when COVID-19 symptoms first occur so that they can self-isolate and seek medical care, thus helping to suppress the pandemic curve.
The initiative is sponsored by BARDA’s Divisions of Research, Innovation, and Ventures (DRIVe) and Detection, Diagnostics, and Devices Infrastructure (DDDI).
For additional information, see solicitation AOIs 11A: Home-based, Over-the-Counter Diagnostics for the Detection of SARS CoV-2 and 11B: Enabling Technologies to Support Home-Based Diagnostics for SARS-CoV-2 Acute Infection in the Special Instructions 014 Issuance of the EZ-BAA (BAA-20-100-SOL-0002). Abstracts may be submitted until 5:00PM ET on January 15, 2022.
