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.” 

According to the U.S. Centers for Disease Control and Prevention, 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 more than 2.4 million people – and as many as 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 alone.

The proposed fiscal year 2025 budget for the Department of Health and Human Services includes a proposed five-year program to eliminate hepatitis C in the U.S. The program aims to significantly expand testing, treatment, prevention and monitoring of hepatitis C infections in the U.S. With hepatitis C being the most common cause of liver cancer today, this initiative is an important contribution to President Biden’s Cancer Moonshot.

“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.”

Validation data for the Xpert HCV test and GeneXpert Xpress System was gathered through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program, in collaboration with the FDA. ITAP was 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,” 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 test is indicated for adults with signs or symptoms of, or at risk for hepatitis C and is not intended for use in monitoring patients undergoing treatment or for use in screening blood, plasma or tissue donors. 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.   

The FDA reviewed the Xpert HCV test and GeneXpert Xpress System under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.

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