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Cepheid to Launch FDA-Cleared Healthcare-Associated Infection Test Xpert vanA by End of Month


By Turna Ray 

Cepheid received 510(k) clearance from the US Food & Drug Administration this week for its Xpert vanA, a test that gauges the presence of an antimicrobial resistance gene commonly linked to vancomycin-resistant Enterococci (VRE), a serious healthcare-associated infection.

The test runs on Cepheid's GeneXpert RT-PCR system The FDA-cleared Xpert vanA test will be commercially available for shipment to customers this month.

"As encountered with other HAI-associated pathogens, the lack of a rapid and accurate test for vanA has impacted clinicians' efforts in the recognition, prevention, and control of VRE,” Cepheid CEO John Bishop said in a statement. The run time for the test is 45 minutes, which means turnaround time for results can be as quick as 24 hours, according to the firm.

According to the Centers for Disease Control and Prevention, approximately 30 percent of Enterococcal HAIs are due to VRE.

"Many patients in the areas of oncology, hematology, nephrology, transplant, and abdominal surgery units are at highest risk for contracting VRE. Therefore, it's imperative to prevent potential outbreaks by testing for vanA upon admission of high-risk patients," said David Persing, Cepheid's chief medical and technology officer, in a statement. "Several recent studies have demonstrated that a policy of recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in healthcare settings can lead to a reduction in transmission rates.”

Cepheid is touting the ability of its PCR test to allow hospital workers to control the spread of VRE by taking preventative action by quickly identifying and isolating patients at higher risk of contracting VRE or asymptomatic colonized patients who may spread VRE to other patients.

Xpert vanA is Cepheid's fifth HAI test to receive FDA clearance.

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