November 19, 2021


Josh Berkowitz: (703) 939-7056

WASHINGTON, D.C. – The National Viral Hepatitis Roundtable (NVHR), a national coalition working to eliminate viral hepatitis, today released the following statement from Director of Programs Adrienne Simmons on the Food and Drug Administration (FDA) announcement that the agency will reclassify hepatitis C virus (HCV) ribonucleic acid (RNA) tests and certain HCV antibody tests from class III to II, simplifying the pathway to FDA approval:

“NVHR applauds the FDA for reclassifying HCV RNA tests and certain HCV antibody tests. We are optimistic that reclassification will encourage manufacturers to seek approval for point-of-care HCV RNA tests in the US to reduce the time, cost, and barriers to diagnosing HCV.

“In countries where HCV RNA tests are already approved, HCV diagnosis can happen in as little as an hour and doesn’t require a lab. But in the US, the available testing requires a blood draw, a lab, and often takes more than a day to determine HCV infection status. These unnecessary inefficiencies limit the ability to deploy tests in places such as harm reduction settings and delay diagnosis among those most at risk of continued transmission. This decision is a crucial step in stemming the spread of disease and eliminating viral hepatitis by 2030.

“The FDA decision today around HCV testing is a beacon of hope amid rising infection rates and declining treatment rates. We look forward to working with manufacturers, regulators, patient advocates, and other stakeholders to make rapid HCV diagnostics a reality in the United States.”

Today, the FDA issued two final orders, reclassifying certain HCV diagnostic tests from class III to II. These orders allow these HCV tests to use FDA’s 510(k) pathway rather than submitting a premarket approval application. The two types of HCV diagnostic tests being reclassified are nucleic acid-based HCV ribonucleic acid devices intended for the qualitative or quantitative detection or genotyping of HCV RNA and certain HCV antibody devices intended for the qualitative detection of HCV.


About the National Viral Hepatitis Roundtable (NVHR)

The National Viral Hepatitis Roundtable, an initiative of HEP, is a national coalition fighting for an equitable world free of viral hepatitis. NVHR seeks to eliminate viral hepatitis in the United States and improve the lives of those affected through advocacy, education, and support to national, state and local partners. For more information, visit