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FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test
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Test Enables Single-Visit Testing and Treatment for Hepatitis C
For Immediate Release:
June 27, 2024
https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test
Today, the U.S. Food and Drug Administration 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, M.D., J.D., 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."
"A third of people with hepatitis C in the United States don't even know they have a deadly, yet curable, infection," said Jonathan Mermin, M.D., M.P.H., director of CDC's National Center for HIV, Viral Hepatitis, STD and TB Prevention. "This new test provides hope that more people will be cured, but it will only succeed if it is affordable and available."
"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," said National Institute of Biomedical Imaging and Bioengineering (NIBIB) director Bruce J. Tromberg, Ph.D. "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."
The risks associated with the test include the possibility of false positive and false negative test results. False negative test results can delay effective treatment and potentially increase spread of infection to other persons throughout the community. False positive results could lead to an inappropriate diagnosis of, and unnecessary treatment for hepatitis C. This could cause psychological distress and delay receiving a correct diagnosis, in addition to the expense and risk of side effects from unnecessary treatment.
"This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care. This enables diagnosis of HCV and facilitates timely linkage to care within a single clinic visit — and with this, the potential for treating more people with HCV," said Vitor Rocha, President of Cepheid.
https://cepheid.mediaroom.com/2024-06-27-Cepheid-Receives-FDA-Authorization-with-CLIA-Waiver-for-Xpert-R-HCV
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