NEW YORK – The US Food and Drug Administration announced Thursday that it has granted de novo authorization to Danaher subsidiary Cepheid for a point-of-care molecular test for detecting hepatitis C virus.
The Xpert HCV test, which runs on the firm's GeneXpert Xpress platform, detects hepatitis C RNA from a fingerstick blood sample and delivers results in about an hour, the FDA said in a statement. It is the first point-of-care RNA test cleared for marketing by the FDA for the disease.
The test is indicated for adults with signs and symptoms of hepatitis C or who are at risk for hepatitis C. It is not intended for use in monitoring patients undergoing treatment or for screening of blood, plasma, or tissue donors.
The test can be performed in CLIA-waived settings such as correctional facilities, doctors' offices, emergency departments, urgent care clinics, and syringe service programs, the FDA noted.
"Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "Equipping healthcare providers with tools to diagnose and treat patients in the same visit can result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and additional spread of the virus."