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Cepheid Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 28 Sep 2020
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Image: GeneXpert System (Photo courtesy of Cepheid)
Image: GeneXpert System (Photo courtesy of Cepheid)
Cepheid (Sunnyvale, CA, USA) has been issued an emergency use authorization (EUA) by the US Food and Drug Administration for its four-in-one combination test for SARS-CoV-2, Flu A, Flu B and RSV.

The Xpert Xpress SARS-CoV-2/Flu/RSV four-in-one test is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a single patient sample. The regulatory authorization will make the test available globally on its cartridge-based GeneXpert Systems, which features instruments that can be configured for both near patient point-of-care and high volume laboratory testing needs.

The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine. Cepheid’s line of GeneXpert Systems can be configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with two or four modules, meaning up to four different tests can be run at one time. The company’s largest GeneXpert System is configured with up to 80 modules, meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day.

“Leveraging the quality design of Xpert Xpress SARS-CoV-2 and our widely utilized Xpert Xpress Flu/RSV tests, we're combining two world-class products in a single, rapid solution ahead of the upcoming flu season,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. “This will enable our customers to have increased testing throughput on their current GeneXpert System and increase our ability to provide supply continuity for the market.”

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