Now accepting submissions to develop home-based, over-the-counter diagnostics for the detection of SARS-CoV-2 and technologies to support and improve at-home testing.
BARDA's Divisions of Research, Innovation, and Ventures (DRIVe) and Detection, Diagnostics, and Devices Infrastructure (DDDI) opened a new area of interest (AOI) 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.
Improving access to rapid, low-cost, at-home tests is a critical component of the Administration’s COVID-19 plan to get out of the pandemic. At-home diagnostics can empower individuals with better knowledge about their infection status, and ultimately reduce community transmission.
To meet this need, BARDA is seeking partners to develop home-based, over-the-counter technologies to detect SARS-CoV-2 acute infection as part of a new “COVID-19 At Home Diagnostics” program. This program seeks to identify and support diagnostics that include critical features such as low cost, high accuracy, ease of use for both the sampling and testing method, rapid output, and straightforward interpretation of results. 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.
Abstracts may be submitted until 5:00PM ET on January 15, 2022. 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 (PDF - 286KB) in the Special Instructions 014 Issuance of the EZ-BAA (BAA-20-100-SOL-0002), and visit drive.hhs.gov/partner.
BARDA's Division of Research, Innovation, and Ventures (DRIVe) established the EZ-BAA to streamline the application process for the review of transformative products and technologies to protect the U.S. from health security threats. Since its inception in 2018, BARDA DRIVe's EZ-BAA solicitation has received hundreds of abstract submissions annually, with awards made in as few as 30 days. The EZ-BAA has helped transform the solicitation process and provides innovators, entrepreneurs, and organizations with a simplified and rapid mechanism to propose ideas to the U.S. government. The application process is both business-friendly and easy to follow.