FDA Approves First Point-of-Care RNA Test for Hepatitis C

The U.S. Food and Drug Administration has approved Cepheid's Xpert HCV test and GeneXpert Xpress System, the first point-of-care test for hepatitis C virus (HCV). This test can now be used in various settings, including certain clinics, substance use treatment centers, correctional facilities, and emergency departments, as long as they have a CLIA Certificate of Waiver. Unlike traditional methods that require sending samples to a central lab, this test uses a fingertip blood sample to detect HCV RNA, delivering results in about an hour.

This new test supports a streamlined approach where patients can be tested and, if positive, quickly connected to care and potentially receive treatment during the same visit. Previously, HCV testing required multiple steps and follow-up visits, which often resulted in delays or missed diagnoses and treatments. This advancement aims to simplify the process, making it easier for patients to receive timely and necessary care.  

SOURCE: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test 

CREDITS: U.S. FOOD AND DRUG ADMINISTRATION