Cepheid says FDA approves test for a gene linked to resistance to the antibiotic vancomycin

FDA clears Cepheid molecular test for vanA gene

SUNNYVALE, Calif. — Cepheid said Wednesday it received regulatory clearance to sell a test that detects a gene associated with resistance to a powerful antibiotic.

The molecular diagnostics company said the Food and Drug Administration approved its Xpert vanA test, which is designed to detect a gene connected with resistance to the antibiotic vancomycin, which is often used to treat hospital-acquired infections. The vanA gene is the gene most commonly associated with vancomycin resistance.

The test runs on Cepheid’s GeneXpert System and can detect the vanA gene in 45 minutes, the company said.