FDA Authorizes Marketing of First-Ever Point-of-Care Hepatitis C RNA Test


Through a test-and-treat approach, patients who test positive for HCV RNA with the Xpert HCV test and GeneXpert Xpress System can be connected to care as soon as the same health care visit.

The FDA has granted marketing authorization to Cepheid for the first-ever point-of-care hepatitis C virus (HCV) test, the agency announced in a release.1 It is indicated for adults with signs, symptoms, or risk factors for HCV. It is not intended for treatment monitoring or blood screening.

Blood sample positive with hepatitis C / jarun011 - stock.adobe.com

Blood sample positive with hepatitis C / jarun011 - stock.adobe.com

Used in conjunction with the Gene Xpert Xpress System, the Xpert HVC test allows appropriately certified point-of-care settings to diagnose HCV on-site, providing a convenient alternative to outsourcing blood samples to a central lab for testing. It may be performed in settings operating under a 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, and delivers results in about an hour.

Key Takeaways

  • The FDA has approved a new point-of-care test for diagnosing HCV infection. This means health care providers can now diagnose HCV on-site, providing faster results and potentially leading to earlier treatment.
  • The new HCV test utilizes a test-and-treat approach, where patients can be connected to treatment resources immediately after a positive test result.
  • The authorization of this new test aligns with the Department of Health and Human Services' plan to eliminate HCV in the US in a 5-year plan. Increased access to testing is a key part of this plan.

The test utilizes a test-and-treat approach that further streamlines care. Upon a positive test result for HCV RNA, patients can be connected to treatment resources as soon as the same health care visit. Previously, patients often required follow-up appointments for test results and additional testing, which could delay diagnoses and 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, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the news release.1 “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.”

READ MORE: Examining Immune Response of Hepatitis B Vaccines in Patients With HCV

Authorization from the FDA was supported by validation data through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program, in partnership with the FDA.

“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 Bruce J. Tromberg, PhD, director of the National Institute of Biomedical Imaging and Bioengineering, in the same release.1 “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.”

Millions of Americans have hepatitis C,2 which if left untreated, can cause serious health problems such as liver cancer and failure. In 2022 alone, HCV contributed to over 12,000 deaths. Although it can be a short-term illness for some, hepatitis C becomes chronic for over half of infected individuals. However, when caught early, it is curable.

Recognizing this urgency, the Department of Health and Human Services proposed in their 2025 budget a 5-year plan to eliminate HCV in the US.3 The program aims to increase testing, treatment, prevention, and monitoring efforts. The authorization of the Xpert HCV test directly supports this goal by expanding the accessibility of detection resources.

“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, MD, MPH, director of CDC’s National Center for HIV, Viral Hepatitis, STD and TB Prevention.1 “This new test provides hope that more people will be cured, but it will only succeed if it is affordable and available.

READ MORE: Infectious Diseases Resource Center

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1. FDA permits marketing of first point-of-care hepatitis C RNA test. News release. FDA. June 27, 2024. Accessed June 28, 2024. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test?utm_medium=email&utm_source=govdelivery
2. Gnanapandithan K, Ghali MP. Self-awareness of hepatitis C infection in the United States: A cross-sectional study based on the National Health Nutrition and Examination Survey. PLoS One. 2023;18(10):e0293315. doi:10.1371/journal.pone.0293315
3. Launching a national hepatitis C elimination program in the United States. Fact sheet. HHS. Accessed June 28, 2024. https://www.hhs.gov/sites/default/files/hep-c-elimination-program-1-pager-508.pdf
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