FDA Grants Marketing Authorization to Xpert HCV, First Point-of-Care Hepatitis C RNA Test

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Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test allowing for a more rapid test-and-treat approach compared to the standard multi-step HCV testing process.¹

According to a release from the FDA, the test is intended for adults at risk of or with signs or symptoms of HCV and may be performed in settings operating under a Clinical Laboratory Improvement Amendments (CLIA) 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 provides results in about an hour using a blood sample from the fingertip.¹

“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 a press 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.”

According to the World Health Organization, an estimated 50 million people have chronic HCV infection, with about 1 million new infections occurring per year. Although direct-acting antivirals can cure more than 95% of persons with hepatitis C infection, access to diagnosis and treatment is low. Additionally, because new HCV infections are often asymptomatic, diagnosis typically does not occur when the infection is recent. In those who develop chronic HCV infection, the infection is often undiagnosed until decades later when symptoms develop secondary to serious liver damage.²

Prior to the availability of a rapid, point-of-care test, HCV testing has been a multi-step process, often resulting in patients needing follow-up appointments for test results and additional testing and potentially leading to patients not receiving a diagnosis and/or necessary treatment.¹

“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 US Centers for Disease Control and Prevention’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.”

According to a press release from the FDA, the test is not intended for use in monitoring patients undergoing treatment or for use in screening blood, plasma, or tissue donors. Potential risks include the possibility of false positive and false negative test results. False negative test results can delay effective treatment and potentially increase the spread of infection, while false positive results could lead to an inappropriate diagnosis of and unnecessary treatment for hepatitis C.¹

The FDA reviewed the Xpert HCV test and GeneXpert Xpress System under the FDA’s De Novo premarket review pathway, a regulatory pathway for new types of low- to moderate-risk devices. 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 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 public availability of high-quality, accurate, and reliable diagnostic tests.¹

“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 Tromberg, PhD, director of the National Institute of Biomedical Imaging and Bioengineering.¹

References

1. ^{US Food and Drug Administration. FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test. June 27, 2024. Accessed June 27, 2024. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test}
2. ^{World Health Organization. Hepatitis C. Newsroom. April 9, 2024. Accessed June 27, 2024. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c}