Cepheid's test for vancomycin-resistant infections gets FDA OK
This article was originally published in Clinica
Executive Summary
Cepheid's Xpert vanA test has received 510(k) clearance from the US FDA. It is the first rapid and accurate test released in the US for vanA, the gene most commonly associated with vancomycin-resistant Enterococci (VRE), the company claims. The test provides results in 45 minutes and runs on Cepheid's GeneXpert system. VRE accounts for around 30% of healthcare-associated infections, according to the US Centers for Disease Control and Prevention. Sunnyvale, California-based Cepheid also markets tests in the Xpert brand for Clostridium difficile, methicillin-resistant and -sensitive Staphylococcus aureus, and H1N1 (under an FDA emergency use authorisation).