FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test Test Enables Single-Visit Testing and Treatment for Hepatitis C

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test Today, the U.S. FDA has approved the first rapid hepatitis C virus test for the U.S. market that can be used in patient care settings. The test, which was validated in part by the NIH RADx Tech program with funding from CDC, can provide results in about one hour, meaning patients with a positive test can begin treatment right away. Although a cure for hepatitis C is available, many people with the potentially deadly disease are not aware that they have it and do not receive treatment. This is partly because hepatitis C testing has been a lengthy process before results are available and requires follow-up appointments. But now, it will be possible to obtain a test result and start a course of treatment at the same health visit. https://www.nibib.nih.gov/about-nibib/directors-corner