FDA Authorizes Cepheid’s Molecular Test for Hepatitis C Detection from Fingerstick Blood Samples

Cepheid has received de novo authorization from the FDA for a molecular test that can detect hepatitis C virus RNA directly from fingerstick blood samples, revolutionizing the healthcare industry. The Xpert HCV test, running on Cepheid’s Genexpert Xpress System, provides rapid results within one hour, eliminating the need for samples to be sent to central labs. This game-changing approval enables same-visit diagnosis and treatment, potentially increasing the number of hepatitis C patients being diagnosed and treated promptly.