A single test intended to detect COVID-19, influenza and respiratory syncytial virus (RSV) will receive advanced development support through a collaboration between the BARDA, the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, the U.S. Army Medical Materiel Development Activity (USAMMDA), and Cepheid, Inc., of Sunnyvale, California. Cepheid has completed the development and studies required to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). EUA was granted in September 2020.
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. 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.
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.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation’s (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit https://www.cepheid.com/.