Cepheid Receives CE-IVD Registration for SARS-CoV-2, Flu A, Flu B and RSV Combination Test

Cepheid (Sunnyvale, CA, USA) has received the CE-IVD marking for its 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, which received Emergency Use Authorization from the US Food & Drug Administration in September 2020, is now available in the European Union and other markets that recognize CE-IVD marking. 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 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. GeneXpert Systems are configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with 2 or 4 modules - meaning up to four different tests can be run at one time. The 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.

"Things may get complicated this respiratory season as clinicians encounter a range of viral infections with symptoms overlapping with COVID-19, including Flu A, Flu B, and respiratory syncytial virus," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "The ability to run a single, highly sensitive test that detects all four viruses in a syndromic panel provides actionable results and helps to alleviate pressure on our healthcare system."

"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."