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

Today, the U.S. Food and Drug Administration (FDA) is granting marketing authorization to Cepheid for the Xpert HCV test performed on the GeneXpert Xpress System. This is the first hepatitis C virus (HCV) ribonucleic acid (RNA) test (a test that detects genetic material called RNA from the virus) for use in a point-of-care (POC) setting.

A few ways this new test is different than previous tests:

• Testing happens on-site. The tests can be used in appropriately certified point-of-care settings such as doctors’ offices, community-based clinics, urgent care centers, outpatient health care facilities, and emergency rooms, without needing to send a sample to a central laboratory

• Results as fast as one hour. Before rapid, point-of-care testing, HCV testing was a multi-step process.

• Immediately linked to care. Unlike current HCV testing, this test allows patients to be diagnosed and linked to care, including discussion of treatment options, all in the same visit.

Testing and Diagnosis of Hepatitis C

Many people do not know they have hepatitis C, partly due to the lack of availability of convenient, widespread testing options. The authorization of this test will help people to get the diagnosis and treatment they need, faster, which will save lives. This test has the potential to reduce rates of liver failure, cirrhosis, and liver cancer caused by hepatitis C infection. With quicker linkage to care, the spread of hepatitis C may also be reduced.

Questions?

If you have questions about the marketing authorization for the Cepheid Xpert HCV test and GeneXpert Xpress System contact the Division of Industry and Consumer Education.