Today, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in hepatitis C virus (HCV) diagnosis. This approval introduces the first HCV test capable of delivering results at point-of-care settings, providing a faster and more accessible diagnostic option for individuals at risk.
Revolutionary Diagnostic Tool
Point-of-Care Testing
The newly authorized Xpert HCV test allows for rapid HCV RNA detection using a fingertip blood sample, delivering results in approximately one hour. This innovation means that settings operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, such as substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments, and urgent care clinics, can now perform HCV testing on-site. This eliminates the need to send samples to a central lab, streamlining the diagnostic process significantly.
Test-and-Treat Approach
The authorization of this test facilitates a test-and-treat approach, enabling healthcare providers to test for HCV and, if positive, link patients to care and potentially initiate treatment during the same visit. Prior to this, HCV testing was a multi-step process requiring follow-up appointments, which often led to patients not receiving timely diagnosis or treatment.
Addressing the Hepatitis C Epidemic
The Prevalence of Hepatitis C
Hepatitis C, a liver infection caused by the hepatitis C virus, is spread through contact with blood from an infected person. While some individuals experience a short-term illness, more than half of those infected develop a long-term, chronic infection. The Centers for Disease Control and Prevention (CDC) estimate that over 2.4 million people in the United States are living with hepatitis C, with some estimates as high as 4 million. Left untreated, HCV can lead to severe outcomes such as liver cancer and liver failure, contributing to over 12,000 deaths in 2022 alone.
Bridging the Diagnosis Gap
Image Source FDA
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, highlighted the importance of the new test: “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. 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.”
The Road to Approval
Independent Test Assessment Program (ITAP)
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. Launched in 2021, ITAP aims to accelerate test evaluation to support the FDA’s regulatory review, ensuring high-quality, accurate, and reliable diagnostic tests reach the public swiftly.
Expanding Beyond COVID-19
Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), noted the broader implications of the ITAP program: “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. 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.”
Addressing Risks and Regulatory Pathways
Risks and Limitations
While the Xpert HCV test offers numerous benefits, it is not without risks. Potential false positive and false negative results can lead to inappropriate diagnoses and unnecessary treatments, or delayed treatments and increased spread of infection, respectively. The test is intended for adults showing signs or symptoms of HCV or those at risk, but it is not suitable for monitoring treatment or screening blood, plasma, or tissue donors.
Regulatory Approval Process
The FDA reviewed the Xpert HCV test and GeneXpert Xpress System under the De Novo premarket review pathway, a regulatory route for low- to moderate-risk devices of a new type. Along with the De Novo authorization, the FDA established special controls regarding labeling and performance testing. These controls, combined with general controls, provide reasonable assurance of the test’s safety and effectiveness. This action also creates a new regulatory classification, allowing subsequent devices of the same type to go through the FDA’s 510(k) premarket process, potentially saving developers time and expense.
Future Implications
National Hepatitis C Elimination Initiative
The proposed fiscal year 2025 budget for the Department of Health and Human Services includes a five-year program aimed at eliminating hepatitis C in the U.S. This initiative plans to expand testing, treatment, prevention, and monitoring efforts, aligning with President Biden’s Cancer Moonshot to combat liver cancer, a common consequence of untreated HCV.
Increased Accessibility and Affordability
Jonathan Mermin, M.D., M.P.H., director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, emphasized the importance of accessibility: “A third of people with hepatitis C in the United States don’t even know they have a deadly, yet curable, infection. This new test provides hope that more people will be cured, but it will only succeed if it is affordable and available.”
The FDA’s approval of the Xpert HCV test and GeneXpert Xpress System represents a significant milestone in the fight against hepatitis C, promising to enhance early detection and treatment, ultimately improving patient outcomes and public health.
Join TISHHA.
