FDA clears first ‘rapid diagnostic’ hepatitis C RNA test for point-of-care settings
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The FDA granted marketing authorization for Cepheid’s Xpert HCV test and GeneXpert Xpress System, the first rapid test for hepatitis C virus intended for use in point-of-care settings.
According to the agency, the test detects HCV RNA using a fingertip blood sample, allowing results to be delivered within 1 hour. The FDA’s authorization “enables a test-and-treat approach,” in which an at-risk individual can be tested for HCV – and if positive – be linked to appropriate care, and possibly receive treatment, during the same health care visit.
“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,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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.”
Previously, HCV testing had been a multistep process in which patients required follow-up appointments to receive results and undergo additional testing, which led to patients not receiving diagnosis and proper treatment, the FDA stated.
This “rapid, point-of-care test” may be performed in settings that operate under a Clinical Laboratory Amendments Certificate of Waiver including certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments and urgent care clinics, the agency noted. However, the test should not be used to monitor patients undergoing treatment or for screening blood, plasma or tissue donors.
Further risks correlated with the test include the potential for false positive and false negative test results, which may respectively lead to “inappropriate diagnosis of, and unnecessary treatment” for HCV or a “delay in effective treatment.”
The Xpert HCV test and GeneXpert Xpress System were reviewed through the FDA’s de novo premarket review pathway. In partnership with the FDA, validation data were collected through the Independent Test Assessment Program (ITAP), a NIH Rapid Acceleration of Diagnostics (RADx) Tech program that launched in 2021 “to accelerate test evaluation to support the FDA’s regulatory review and the availability of high-quality, accurate and reliable diagnostic tests to the public.”
“Today’s announcement by the FDA of marketing authorization for a rapid diagnostic to detect hepatitis C RNA is an example of the power of the RADx Tech model to deliver a much-needed test to millions of people in record time,” Bruce J. Tromberg, PhD, director of the National Institute of Biomedical Imaging and Bioengineering director, said in the release. “Although our ITAP partnership with the FDA was originally designed to accelerate regulatory authorization of reliable home and point-of-care tests for COVID-19, we’ve successfully expanded the program across HHS to include tests for hepatitis C and several other innovative diagnostics.”
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