FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test

The U.S. Food and Drug Administration has granted marketing authorization for the Xpert HCV test and GeneXpert Xpress System, agency announced on June 27.

This is first hepatitis C virus (HCV) test that can be used to diagnose HCV in point-of-care settings that operate under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, including some substance use disorder treatment facilities; correctional facilities; syringe service programs; doctor’s offices; emergency departments; and urgent care clinics.

The test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip. To date, HCV testing has involved a multistep process that could require follow-up appointments for more testing and to convey results.

“The authorization of this test enables a test-and-treat approach where a person can be tested for HCV, and if positive for HCV RNA, be linked to care and potentially receive treatment during the same health care visit,” FDA stated in its release.

It is estimated that more than 2.4 million people – and perhaps as many as 4 million people – in the United States have HCV, the most common cause of liver cancer today. The infection contributed to more than 12,000 deaths in 2022 alone. As many as one-third of people infected with HCV do not know they have the infection.

The test is indicated for adults with signs or symptoms of, or at risk for, hepatitis C and is not intended for use in monitoring patients undergoing treatment or for use in screening blood, plasma or tissue donors. The risks associated with the test include the possibility of false positive and false negative test results.

Reference:

FDA permits marketing of first point-of-care hepatitis C RNA test. Press release. US Food and Drug Administration; June 27, 2024. Accessed June 28, 2024. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test