Cepheid Developing Combination Test for SARS-CoV-2, Flu A/B, and RSV
By PR Newswire | 06.09.20
Four viral infections have similar patient presentations; accurate detection and differentiation critical next flu season.
"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."
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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.
"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."