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May 20, 2025
COMMUNITY AND GLOBAL HEALTH
Whitepaper
A Breakthrough in HCV Elimination: How HCV Point-of-Care RNA Testing Came to the United States
Jennifer Rakeman-Cagno, Senior Director of Medical and Scientific Affairs at Cepheid, was one of five presenters who shared their perspectives and lessons learned in bringing point-of-care HCV RNA testing to the U.S.
Executive Summary
Hosted by the U.S. Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Coalition for Global Hepatitis Elimination, the latest webinar in the NIH “Moving from Hepatitis Discovery to Elimination” series provided a detailed account of how HCV point-of-care RNA testing came to the United States: the new test received authorization on June 24, 2024, by the Food and Drug Administration (FDA).
Though point-of-care HCV RNA tests have been available internationally for several years, the story of their approval for use in the US begins and ends with partnerships—across government, academia, industry, and more. The newly approved fingerstick test could improve HCV testing and treatment rates nationwide, particularly among hard-to-reach populations.
Traditional two-step processes for diagnosing and treating HCV can take substantial time and multiple visits, from the initial screening to follow-up testing and provision of medication. Along the way, multiple challenges confront care providers—incomplete testing, loss to follow up, or the potential to miss early HCV infection, among other obstacles. Now, having a rapid RNA diagnostic test makes same day “test-and-treat” possible. It means that a patient can learn her infection status in one visit and, if infected, receive medication and/or linkage to care moving forward. With the June 24, 2024, authorization of the point-of-care Xpert HCV test by the FDA, a significant step toward eliminating HCV has been achieved.
Dr. Nate Furukawa (CDC) served as host and moderator of the webinar. Dr. Francis Collins (NIH) provided welcome remarks by video recording. Previously serving as lead for the United States National Hepatitis C Elimination Initiative, Collins noted that HCV is estimated to affect 4 million Americans nationwide, though many individuals do not know they are infected until they present with serious symptoms such as liver damage. Curative therapies are available, but access to these medications remains a challenge. Only 1 in 3 adults diagnosed with the disease in the US has been cured.
Read the paper presented by The Coalition for Global Hepatitis Elimination.
US-IVD. In Vitro Diagnostic Medical Device.
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