Cepheid announces development of combination test for four viral infections
These four viral infections have similar patient presentations, making accurate detection and differentiation critical during next flu season
17 Jun 2020
Cepheid has announced the development of a next-generation test to assist global efforts in the fight against the spread of COVID-19 during the upcoming respiratory virus season. 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 test is designed for use on any of Cepheid's more than 25,000 GeneXpert® Systems placed worldwide, with results expected in as little as 35 minutes.
"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."
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."
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GeneXpert System
CepheidThe GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.