Cepheid Develops Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV

In the coming weeks, Cepheid intends to pursue the FDA's Emergency Use Authorization (EUA) pathway for regulatory authorization and 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.

"Patients infected by SARS-CoV-2, Flu A, Flu B, and RSV have overlapping clinical presentations, but fundamentally different treatment and management pathways," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "Unlike the common cold viruses, infection with these four viruses is often associated with fever and other systemic manifestations that may be coupled with severe outcomes, especially in the elderly."

"On March 20th, Cepheid was granted the first-ever EUA by the FDA for use in point-of-care settings for our Xpert Xpress SARS-CoV-2 test," said Cepheid President Warren Kocmond. "Since then, we have experienced unprecedented demand for this technology. 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. 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."