Cepheid has received emergency use authorization for a molecular test that can detect viruses causing COVID-19, flu, and RSV infections.
The Sunnyvale, CA-based company is designed for use on the GeneXpert system, with results delivered in about 36 minutes. The combination test is set to begin shipping the U.S. this week. However, Europe will see availability of the molecular test in November.
The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patients 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.
"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 David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid, in a release. "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."
Cepheid’s parent company Danaher has been deep in the fight for COVID-19 detection. Beckman Coulter, another Danaher company, obtained EUA for an antibody test in late June.