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BARDA and JPEO-CBRND Back Cepheid’s Multiplex Test for Influenza, SARS-CoV2 and RSV

During the upcoming flu season, public health and medical professionals will require diagnostic tools to determine if a patient with fever and respiratory symptoms has COVID-19 or influenza, to better enable proper patient management and treatment.

A single test intended to detect COVID-19, influenza and respiratory syncytial virus (RSV) will receive advanced development support through a new collaboration between the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), the U.S. Army Medical Materiel Development Activity (USAMMDA), and Cepheid, Inc., of Sunnyvale, California.

Cepheid’s Xpert Xpress SARS-CoV-2/Flu/RSV test is being designed to provide rapid, qualitative detection of SARS-CoV-2, Influenza A, Influenza B, and RSV; as well as distinguish between these diseases in a single-patient sample. The test will operate on Cepheid’s GeneXpert systems, in both laboratory and point-of-care settings.

“Things may get complicated this respiratory season as clinicians encounter a range of viral infections with symptoms overlapping with COVID-19, including Flu A, Flu B, and respiratory syncytial virus,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. “The ability to run a single, highly sensitive test that detects all four viruses in a syndromic panel provides actionable results and helps to alleviate pressure on our healthcare system.”

Development of the test will leverage Cepheid’s FDA-cleared Xpert Xpress Flu/RSV test and their Xpert Xpress SARS-CoV-2 test; the latter developed through a partnership between the BARDA, the JPEO-CBRND, and Cepheid, Inc. and granted EUA by the FDA on March 20, 2020.

An Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) was granted to the company at the end of September.

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