New rapid test expected to play key role in eliminating hepatitis C in the U.S.

Today’s announcement by the U.S. Food and Drug Administration (FDA) of market authorization for the first rapid, point-of-care (POC) diagnostic test for the hepatitis C virus (HCV) is due in part to the ingenuity of NIBIB’s special partnership with the FDA, the RADx® Tech Independent Test Assessment Program (ITAP). We celebrate that the RADx Tech model, designed to speed COVID-19 tests to the public during the pandemic, has successfully delivered a much-needed test for the millions who could benefit from treatment for this deadly and debilitating disease. The FDA authorization comes less than five months from the start of the clinical trial, testament to the accelerating power of the FDA/RADx Tech collaboration. 

The authorization of a POC test for HCV is a potential game changer, both for patients and the taxpayer. As many as four million Americans are infected with HCV, a disease with slow progression that can lead to liver failure, liver cancer, and death. These outcomes are devastating to patients and costly to the U.S. healthcare system, with untreated HCV estimated to cost over $4 billion in the next 10 years. Remarkably, safe antiviral drugs have been available since 2014 that are 95 percent effective in curing hepatitis C. The paradox is that only a fraction of people with HCV have access to treatment because 1) one in three people with active HCV do not know they are infected and 2) even when diagnosed, the cost of treatment is out of reach for the under- and uninsured. 

The Biden-Harris administration has proposed a program to resolve this paradox and eliminate hepatitis C in the U.S. over a five-year period.^1,2 The availability of a POC HCV test is a necessary first step. This test addresses the currently impractical reality that getting treatment requires three visits to the doctor’s office: 1) screening for exposure to HCV, 2) drawing blood and sending it to a lab for testing, and 3) returning to learn the results of the test and receive treatment. Because hepatitis C disproportionately affects people who have limited access to healthcare, many who undergo screening or testing are lost to follow-up and never receive a final diagnosis or treatment. This new POC test allows the possibility for anyone to walk into a clinic or physician’s office to get tested, get results in under an hour, and start a simple 8- to 12-week, daily oral treatment at the same visit. This test-to-treat model is the basis for the proposed federal program, with the goal of eradicating hepatitis C nationwide. 

The RADx Tech program launched in 2020, when our imperative was to produce millions of COVID-19 tests and test products for the American public during the height of the pandemic.³ In 2021, RADx Tech established the ITAP collaboration with the FDA, to accelerate authorization of tests from outside the U.S. and rapidly increase testing capacity during the Omicron variant surge. Based on the successes with COVID-19 tests, we envisioned that the RADx Tech model could be the key to generating diagnostics and health innovations for other urgent health needs. 

To efficiently produce the data that the FDA used in the HCV test authorization, RADx Tech/ITAP drew upon existing research cores for validation and clinical trials. By tapping into existing HCV clinical trial networks, many located in areas with high concentrations of HCV infection, our team could proceed quickly to conduct the studies and generate the data needed for authorization. Those clinical trial sites had previously been established and supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), and the National Institute on Aging. Funding for the RADx/ITAP effort came from multiple NIH institutes and offices, and HHS agencies. Including NIBIB, contributions totaling $9.1 million were made by NIH’s Office of AIDS Research, Office of the NIH Director, NIAID, National Institute on Drug Abuse, NCI, and the Centers for Disease Control and Prevention. 

NIH Director Dr. Monica Bertagnolli has said that our research is not done until we get devices, technologies and treatments to the patients who need them. The FDA authorization of the HCV POC test is one example of achieving this goal through interagency partnership. 

During the pandemic our singular focus was on producing COVID-19 tests so people could get treatment and to reduce transmission of the virus. We now have a well-tested model for development, validation, and commercialization of POC and at-home technologies that was unimaginable before the pandemic. RADx Tech is eager to continue our partnerships and collaborations to bring forward more needed technologies for infectious disease, chronic disease and disease prevention. Current projects include POC platforms for HIV, POC tests for mpox and other lesion-presenting diseases, technologies for women’s health and fetal monitoring, and medical technologies to treat nervous system disorders, among others. Looking forward, we see limitless potential for RADx Tech to accelerate new technologies to market, to the point-of-care, and into people’s homes.

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1. Fleurence RL, Collins FS. A National Hepatitis C Elimination Program in the United States: A Historic Opportunity. JAMA. Apr 18 2023;329(15):1251-1252. doi:10.1001/jama.2023.3692
2. Launching a National Hepatitis C Elimination Program in the United States
3. Tromberg BJ, Schwetz TA, Perez-Stable EJ, et al. Rapid Scaling Up of Covid-19 Diagnostic Testing in the United States - The NIH RADx Initiative. N Engl J Med. Sep 10 2020;383(11):1071-1077. doi:10.1056/NEJMsr2022263