FDA Grants Marketing Authorization to Point-of-Care Test for Hepatitis C

June 28, 2024
The test has the potential to allow patients to test for hepatitis C and receive treatment for the infection during the same clinic visit.

The FDA has announced that it is granting marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, “the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.”

The test “detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip.” This opens a pathway to patients who test positive being able to receive treatment during the same healthcare visit, when previously, HCV testing has been a multi-step process.

Hepatitis C is a liver infection spread through contact with blood from a person with hepatitis C. In more than half of people with HCV infection, the disease becomes a “long-term, chronic infection.” Somewhere between 2.4 and 4 million people in the U.S. have hepatitis C, which often leads to “serious and sometimes deadly outcomes such as liver cancer and liver failure” if left untreated. The infection accounted for more than 12,000 deaths in 2022.

The Department of Health and Human Services is aiming to implement a five-year program to eliminate hepatitis C in the U.S. Since that proposed program would require rapid expansion of testing, the use of a device like the Xpert HIV test and GeneXpert Xpress System would provide “hope that more people will be cured” due to affordable and available testing.

About the Author

Matt MacKenzie | Associate Editor

Matt is Associate Editor for Healthcare Purchasing News.