FDA approves first rapid Point-of-Care test for Hepatitis C

USA — The U.S. Food and Drug Administration has granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System.

This is the first hepatitis C virus (HCV) test designed for use in appropriately certified point-of-care settings for individuals at risk for hepatitis C.

The FDA reviewed the Xpert HCV test and GeneXpert Xpress System under its De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

Along with this De Novo authorization, the FDA is establishing special controls defining the labeling and performance testing requirements.

When met, these special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.

This action creates a new regulatory classification, meaning that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process.

Through this process, devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save developers time and expense compared to other review pathways.

The authorization of this test enables a test-and-treat approach where a person can be tested for HCV and, if positive for HCV RNA, be linked to care and potentially receive treatment during the same healthcare visit.

Prior to the availability of a rapid, point-of-care test, HCV testing was a multi-step process.

This often resulted in patients needing follow-up appointments for test results and additional testing, which could lead to patients not receiving a diagnosis and necessary treatment.

Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip.

Validation data for the Xpert HCV test and GeneXpert Xpress System were 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.

 ITAP was launched in 2021 to accelerate test evaluation, support the FDA’s regulatory review, and ensure the availability of high-quality, accurate, and reliable diagnostic tests to the public.

Commenting on this authorization, Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, noted that despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease, partly due to the lack of convenient, widespread testing options.

He hinted that equipping healthcare providers with tools to diagnose and treat patients during the same visit could result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and the spread of additional viruses.

On his part, Jonathan Mermin, M.D., M.P.H., director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, noted that a third of people with hepatitis C in the United States don’t even know they have a deadly, yet curable, infection.

He emphasized that this new test provides hope that more people will be cured, but it will only succeed if it is affordable and available.

Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), stated that the FDA marketing authorization for a rapid diagnostic to detect hepatitis C RNA exemplifies the power of the RADx Tech model to deliver a much-needed test to millions of people in record time.

He added that although their ITAP partnership with the FDA was originally designed to accelerate regulatory authorization of reliable home and point-of-care tests for COVID-19, they have successfully expanded the program across HHS to include tests for hepatitis C and several other innovative diagnostics.

According to the U.S. Centers for Disease Control and Prevention, hepatitis C is a liver infection caused by the hepatitis C virus, with an estimated 2.4 million to 4 million people affected in the United States.

If left untreated, these cases often lead to serious and sometimes deadly outcomes such as liver cancer and liver failure, with the infection contributing to more than 12,000 deaths in 2022 alone. 

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