ANNOUNCEMENT 17 Sep 2021
In September 2021, BARDA announced collaborating with OraSure Technologies, Inc. for the advancement of a COVID-19 rapid antigen test.
NUMBER OF INTERVENTIONS
U.S. Medical Countermeasures, Newsroom, “BARDA renews collaboration with OraSure Technologies, Inc. on InteliSwab COVID-19 Rapid Test”. Available at: https://www.medicalcountermeasures.gov/newsroom/2021/Orasure
On 17 September 2021, Biomedical Advanced Research and Development Authority (BARDA) announced collaborating with OraSure Technologies, Inc. for the advancement of their COVID-19 rapid antigen test through 510(k) submission to U.S. Food and Drug Administration (FDA). For this purpose, BARDA provided USD 13.5 million.
OraSure IntelSwab tast is a single-use rapid COVID-19 test designed for untrained users to make tests and yield quick results within minutes, without any need for instruments or a diagnostic laboratory. In order to legally market a device in the US, several types of premarket submissions shall be made to the U.S. Food and Drug Authority (FDA). 510(k) submission is one of the submissions made to the FDA for those who want to market Class I/II/III devices in the U.S.
Part of the U.S. Department of Health and Human Services (HHS), BARDA supports the development of medical countermeasures such as vaccines, drugs, and diagnostics from research to advanced development through public-private partnerships. Support from BARDA to companies can be in various forms including funding, technical assistance, and other core services. The present announcement didn’t include the type of contribution from BARDA, “state aid, unspecified” is selected as the intervention type.