This article was updated on Feb 11 to reflect the naming of the virus from the provisional 2019-nCoV to SARS-CoV-2. The disease caused by SARS-CoV-2 is now called COVID-19.
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 Coronavirus Disease (COVID-19) rapid diagnostics and is now accepting abstract submissions for potential funding. COVID-19 is spread by the virus SARS-CoV-2, formerly known as 2019-nCoV.
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 COVID-19 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 announcement specifies the following requirements:
The development and Emergency Use Authorization (EUA) of an in vitro diagnostic assay for the detection of 2019-nCoV RNA in clinical specimens, including upper (e.g, nasopharyngeal and oropharyngeal swabs, nasopharyngeal wash/aspirate, or nasal aspirate) and lower (e.g., bronchoalveolar lavage, tracheal aspirate, or sputum) respiratory tract specimens. The assay must be developed for use with an existing FDA-cleared molecular platform that is currently widely placed in U.S. healthcare settings. Respondents should present a viable plan that achieves an EUA submission milestone within 12 weeks of award. As part of the abstract submission, respondents should describe the current development status of their 2019-nCoV assay, including in silico analysis of targets, access to validation materials to support EUA submission, and contacts with the FDA.
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. This area of interest will be open for abstract submissions until 1700 HRS ET on 18 March 2020, unless otherwise extended.