FOR IMMEDIATE RELEASE
WASHINGTON, D.C. (June 28, 2024) – The National Viral Hepatitis Roundtable (NVHR) applauds the U.S. Food and Drug Administration’s (FDA) authorization of the Cepheid Xpert HCV test, the first-ever point-of-care test to diagnose hepatitis C infection in adults. This milestone represents a significant advancement, offering faster and more accessible testing that could expedite hepatitis C treatment initiation and improve health outcomes for millions living with this virus.
As we celebrate this win, NVHR remains committed to the broader goal of eliminating viral hepatitis in the United States. We envision a future where such technologies ensure equitable access to timely diagnosis and care for everyone, and through the collective advocacy of NVHR’s Viral Hepatitis Diagnostics Working Group, we strive to accelerate progress toward that future.
We commend the collaboration between FDA and the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), a Rapid Acceleration of Diagnostics (RADx) Tech program, for accelerating the validation and review of this test. As we await FDA action on down-classification of certain hepatitis B diagnostics, NVHR urges further collaboration between diagnostics manufacturers, FDA, and NIH to bring a hepatitis B point-of-care test to market in the near future.
“This is a historic moment for the viral hepatitis community,” said Adrienne Simmons, Director of Programs for NVHR. “While much work remains to ensure that testing is accessible to all people living with hepatitis C, a point-of-care test is a necessary tool to bring us closer to eliminating this deadly virus. NVHR looks forward to continued partnership with stakeholders across the healthcare ecosystem to harness this advancement and achieve our shared vision of viral hepatitis elimination.”
Previously, diagnosing hepatitis C was a multistep process requiring venous blood to be sent to a lab. In settings operating under a CLIA Certificate of Waiver, the Cepheid Xpert HCV test can be used to diagnose a hepatitis C infection in one hour using a blood sample from a fingertip. For more information about the test, see Cepheid’s website.
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About the National Viral Hepatitis Roundtable (NVHR)
An initiative of the Hepatitis Education Project, the National Viral Hepatitis Roundtable (NVHR) is the largest network of patients, providers, public health leaders, and community partners breaking down barriers to care across the United States. For over 20 years, NVHR has driven progress toward viral hepatitis elimination through knowledge sharing, advocacy, and policy change. To learn more and get involved, visit www.nvhr.org.
MEDIA CONTACTS
Jenni Todd: (206) 934-0711
jennit@hep.org