FDA clears its first fingerstick hepatitis C diagnostic, enabling test-to-treat approach

The FDA has greenlit its first point-of-care diagnostic test for hepatitis C, capable of using only a fingerstick blood sample, in a bid to quickly connect patients with antiviral drugs.

“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,” the agency’s device center director, Jeff Shuren, said in a statement

“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,” Shuren added. 

Testmaker Cepheid received an FDA de novo clearance and a laboratory waiver for its Xpert HCV diagnostic, which runs on its GeneXpert Xpress tabletop PCR system—allowing it to be used not only in doctor’s offices, emergency rooms and urgent care clinics but also at substance use disorder treatment centers, syringe programs and correctional facilities.

Instead of sending a blood sample to a centralized lab for analysis and then requiring patient follow-up appointments, the system can detect the liver virus’ RNA and deliver results in about an hour, spanning all known genotypes. The test is not designed to screen blood donations.

“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, director of the 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 CDC estimates that between 2.4 million and 4 million people in the U.S. may have hepatitis C, which is a top cause of liver cancer and organ failure—with the virus contributing to more than 12,000 deaths in 2022. 

While some people may experience short-term illnesses, more than half will see infections develop into a chronic condition, according to the FDA while untreated cases are expected to cost the healthcare system more than $4 billion over the next 10 years.

Eliminating hepatitis C in the U.S. and its effect on liver cancer rates has been a goal of the Biden administration’s cancer moonshot program. At the same time, the Department of Health and Human Services previously set a target for more than 80% of people with hepatitis C to achieve viral clearance by 2030—while the proposed budget for HHS’ 2025 fiscal year includes a new five-year program to expand testing and prevention efforts.

“This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care,” said Cepheid President Vitor Rocha. “This enables diagnosis of HCV and facilitates timely linkage to care within a single clinic visit—and with this, the potential for treating more people with HCV.”

The test was validated through the National Institutes of Health’s Rapid Acceleration of Diagnostics program, known as RADx, in collaboration with the FDA—a partnership that has expanded beyond its original design of accelerating the authorization of COVID-19 tests. 

“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, director of the NIH’s National Institute of Biomedical Imaging and Bioengineering.