Cepheid Gets Health Canada License For Four-in-one Rapid Molecular Diagnostic Test - Quick Facts

(RTTNews) - Cepheid, a unit of Danaher Corp. (DHR), said Thursday that it has received a medical device license from Health Canada 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.

Cepheid noted that the four-in-one test is designed for use on any of the company's almost 30,000 GeneXpert Systems placed worldwide, with results delivered in approximately 36 minutes.

"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," said Dr. David Persing, Chief Medical and Technology Officer at Cepheid.

Cepheid noted it'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.