FDA Clears Marketing of First Point-of-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 diagnose individuals at appropriately certified points of care for hepatitis C. The test can be performed in facilities operating under a Clinical Laboratory Improvement Amendments (CLIA) waiver certificate, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, physician offices, emergency departments, and urgent care clinics. Rather than requiring a sample to be sent to a central laboratory for analysis, the test detects HCV RNA and provides results in about an hour using a fingerstick blood sample.

The authorization of this test enables a screen-and-treat approach in which a person can be tested for HCV and, if positive for HCV RNA, linked to care and potentially receive treatment during the same health care visit. Prior to the availability of rapid point-of-care testing, HCV testing was a multi-step process that often required patients to schedule follow-up appointments for test results and additional testing, which can lead to patients not receiving a diagnosis and receiving needed treatment.

“Despite the availability of safe and highly effective oral treatment for hepatitis C, many people are unaware they have the disease, in part because of the lack of availability of convenient and widespread testing options,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Equipping health care providers with tools to diagnose and treat patients in a single visit could lead to the diagnosis and treatment of hundreds of thousands more patients with hepatitis C, preventing individual disease progression and further 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 blood contact with someone who has hepatitis C. For some people, hepatitis C is a short-term illness, but for more than half of people infected with HCV, it becomes a long-term, chronic infection.

It is estimated that 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 even fatal consequences. such as liver cancer and liver failure. The infection has contributed to more than 12,000 deaths in 2022 alone.

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

“A third of people in the United States with hepatitis C don’t even know they have a deadly but treatable infection,” said Jonathan Mermin, MD, director of the National Hepatitis C Prevention Center. HIV, Viral Hepatitis, STDs and Tuberculosis from the CDC. “This new test offers hope that more people will be cured, but it will only be effective if it is affordable and available. »

Validation data for the Xpert HCV test and the GeneXpert NIH), in collaboration with the FDA. ITAP was launched in 2021 to accelerate test evaluation to support FDA regulatory review and public availability of high-quality, accurate and reliable diagnostic tests.

“Today’s FDA announcement of marketing authorization for a rapid hepatitis C RNA test is an example of the power of the RADx Tech model to deliver much-needed testing to millions of people in record time,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). “While our ITAP partnership with the FDA was initially designed to expedite regulatory authorization of reliable at-home and point-of-care tests for COVID-19, we have successfully expanded the program across HHS to include hepatitis C tests and several other innovative diagnostics.”

The test is indicated for use in adults with signs or symptoms of, or at risk for, hepatitis C. It is not intended to be used to monitor patients undergoing treatment or to screen blood, plasma, or tissue donors. Risks associated with this test include the possibility of false-positive and false-negative results. False-negative results may delay the effectiveness of treatment and potentially increase the spread of infection to others in the community. False-positive results may lead to inappropriate diagnosis and unnecessary treatment of hepatitis C. This may cause psychological distress and delay in obtaining a correct diagnosis, in addition to the expense and risk of side effects associated with unnecessary treatment.

The FDA reviewed the Xpert HCV Test and GeneXpert Xpress System under FDA’s De Novo premarket review process, a regulatory process for low-to-moderate risk devices of a new kind. Along with this De Novo authorization, the FDA establishes special controls that define requirements related to labeling and performance testing. When followed, special controls, combined with general controls, provide reasonable assurance of safety and effectiveness for testing of this type. This action creates a new regulatory classification, meaning that subsequent devices of the same type with the same intended use can go through the FDA’s 510(k) premarket process, through which devices can obtain marketing authorization. market by demonstrating substantial equivalence to a predicate device, which can save the developer time and money compared to other avenues of review.

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