Danaher Corp. (NYSE:DHR) subsidiary Cepheid announced that it received emergency use authorization from the FDA for its bedside Xpert Xpress SARS-CoV-2 test for detecting the virus causing the COVID-19 outbreak.
The rapid molecular diagnostic test is designed to detect the SARS-CoV-2 virus causing coronavirus while operating on any of Cepheid’s GeneXpert systems worldwide, with a detection time of approximately 45 minutes, according to a news release.
Cepheid chief medical & technology officer Dr. David Persing said in the release that, in developing the COVID-19 test, the company used the design of its Xpert Xpress flue/RSV cartridge technology to target the viral genome and provide rapid detection of current and potential variants of SARS-CoV-2. The outcome is a test that offers results in multiple settings where actionable treatment information is required in a timely manner.
A Bloomberg report stated that Sunnyvale, Calif.-based Cepheid’s test is the 13th one allowed on the market by the FDA and the first that clinicians can use at the bedside. The report also said that Cepheid plans to begin shipping tests next week. The company is joining in on the trend of companies lending a hand in the search for effective testing for the disease.
“Cepheid currently has nearly 5,000 GeneXpert systems in the U.S. capable of point-of-care testing and for use in hospitals,” Cepheid resident Warren Kocmond said in the news release. “Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today.”