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Cepheid Receives Health Canada License for SARS-CoV-2, Flu A, Flu B and RSV Combination Test


Cepheid announced that Health Canada has issued Cepheid a medical device license for Xpert® Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The test is now available in Canada and can be used in laboratories and at the point of care. The four-in-one test is designed for use on any of Cepheid's almost 30,000 GeneXpert® Systems placed worldwide, with results delivered in approximately 36 minutes.

"The ability to run a single, highly-sensitive test that detects SARS-CoV-2, Flu A, Flu B, and respiratory syncytial virus provides actionable results and helps to alleviate pressure on the healthcare system," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "Xpert® Xpress SARS-CoV-2/Flu/RSV delivers reference lab quality testing in a cartridge that can be run near-patient, often providing results while patients are being seen or admitted. Rapid results help healthcare workers make real-time patient management decisions including qualification for antiviral therapy and triage for emergency procedures."

Cepheid's previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for Xpert Xpress SARS-CoV-2/Flu/RSV.

"The dramatic impact of SARS-CoV-2 has been felt by us all, and we understand that a reliable supply of SARS-CoV-2 tests is critical to the communities our healthcare institutions serve — for the coming Flu season and beyond," said Cepheid President Warren Kocmond. "Another goal of the capacity expansion program is to ensure supply continuity of not only our 4-Plex combination test for SARS-CoV-2, Flu A&B and RSV, but the entire portfolio of critical tests Cepheid supplies — including tests for tuberculosis, MRSA, C. difficile, CT/NG, Strep A, and many more."

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