Down-Classification of Hepatitis C Virus Diagnostics: Implications for Screening and Diagnosis.

In November 2021, the U.S. Food and Drug Administration (FDA) reclassified two types of hepatitis C diagnostic tests (HCV antibody and HCV nucleic acid) from Class III to Class II, providing a less burdensome pathway to market for diagnostic companies. This down-classification is anticipated to facilitate innovation in HCV diagnostics, particularly for new point-of-care viral detection assays, and ultimately support HCV elimination efforts by increasing the ease of screening as well as test-and-treat models of HCV care.