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BARDA Awards $12.7M to Chembio to Support FDA Submissions for Respiratory, SARS-CoV-2 Antigen Tests

NEW YORK ─ The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded Chembio Diagnostics $12.7 million, partly to develop a rapid, multiplex DPP Respiratory Antigen Panel point-of-care system for use during the upcoming flu season, Chembio said Wednesday.

The Hauppauge, New York-based firm said it is developing the test system to provide simultaneous, discrete, and differential detection of influenza A, influenza B, and SARS-CoV-2 antigens from a single patient respiratory specimen, such as a nasal or nasopharyngeal swab.

The panel is expected to provide results in approximately 20 minutes and run on the firm's DPP Micro Reader.

Chembio said that the BARDA funding will further support its pursuit of a US Food and Drug Administration Emergency Use Authorization for the system and its application for FDA 510(k) clearance and CLIA-waiver for a rapid DPP SARS-CoV-2 Antigen test system.

The company recently applied for FDA EUA for the SARS-CoV-2 antigen test, which consists of a test cartridge and a DPP Micro Reader analyzer and is designed to use a nasal swab to detect SARS-CoV-2 viral antigens in 20 minutes.