FDA grants marketing authorization for point-of-care hepatitis C test

Last week, the United States FDA granted Cepheid, a molecular diagnostic testing company, marketing authorization for the Xpert HCV test and the GeneXpert Xpress system. Xpert HCV is a molecular test that detects HCV RNA from a whole blood fingerstick using the GeneXpert Xpress System.

These products offer the first tools to test for hepatitis C virus (HCV) in certified point-of-care settings. For example, the test can be used in any setting with a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, including substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments, and urgent care clinics. It delivers results within an hour instead of the traditional HCV testing, which requires results to be sent to a central lab.

“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 FDA press release. “Equipping healthcare 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.” 

Having tools for diagnosing hepatitis C is critical for ensuring public health, as undiagnosed HCV results in untreated cases and further disease spread.

In April 2024, the World Health Organization (WHO) released the 2024 Global Hepatitis Report, which noted 1.2 million global viral hepatitis deaths in 2022, indicating an increase from 2019. According to the report, approximately 17% of those cases were associated with hepatitis C.

The FDA notes that roughly 2.4 million people in the US have hepatitis C; however, many individuals who have the condition go undiagnosed, so the prevalence may be as high as 4 million.

Approximately 25% of individuals who get hepatitis C clear the virus on their own and do not require additional interventions; however, the remaining 75% of cases turn into chronic hepatitis. Chronic hepatitis can remain asymptomatic for a long time, but it eventually results in liver damage and severe side effects such as cirrhosis and liver cancer.

Luckily, there is an effective antiviral treatment course that cures hepatitis within 8–12 weeks in approximately 95% of cases. However, since many patients do not know their HCV status, they cannot be treated.

“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. “This new test provides hope that more people will be cured, but it will only succeed if it is affordable and available.”

The availability of a point-of-care diagnostic tool could improve public health and healthcare spending.

In June 2024, the US Congressional Budget Office report analyzing the impacts of increasing access to hepatitis C treatment revealed that doubling hepatitis C treatment among Medicaid enrollees could yield $7 billion in healthcare savings.