WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has granted 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 may be performed in settings operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor's offices, emergency departments and urgent care clinics.
Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip.
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. Prior to the availability of a rapid, point-of-care test, HCV testing has been a multi-step process which often results in patients needing follow-up appointments for test results and additional testing, which can lead to patients not receiving a diagnosis and not receiving necessary treatment.
'Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options,' said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. 'Equipping health care providers with tools to diagnose and treat patients in the same visit can result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and additional spread of the virus.'
Hepatitis C is a liver infection caused by the hepatitis C virus. Hepatitis C is spread through contact with blood from a person with hepatitis C. For some people, hepatitis C is a short-term illness, but for more than half of people with HCV infection, it becomes a long-term, chronic infection.
It is estimated that 4 million people in the United States have hepatitis C, which if left untreated, often leads to serious and sometimes deadly outcomes such as liver cancer and liver failure. The infection contributed to more than 12,000 deaths in 2022, according to FDA.
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