FDA Green Lights Cepheid’s Xpert HCV Test in Point of Care Settings

The FDA has given the marketing green light to Cepheid for its Xpert HCV test and GeneXpert Xpress System, making it the first hepatitis C virus (HCV) test that can be utilized in certified point-of-care settings for individuals at risk for HCV infection, according to an agency announcement.¹ The test is indicated for adults with signs or symptoms of, or are at risk for, HCV. The agency noted that is not intended for use in monitoring patients undergoing treatment or for use in screening blood, plasma, or tissue donors.

The test can be utilized in settings which operate under Clinical Laboratory Improvement Amendments certificate of waiver—including physician’s offices, emergency departments, and urgent care clinics, as well as substance use disorder treatment facilities, correctional facilities, and syringe service programs. The Xpert test and its GeneXpert Xpress System were validated via data gathered by the NIH’s Independent Test Assessment Program—part of the Rapid Acceleration of Diagnostics Tech program—in collaboration with the FDA.

Jeff Shuren, MD, JD, the director of the FDA’s Center for Devices and Radiological Health, said in a statement that, “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. 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.”

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There is a possibility of false-positive and false-negative test results with the Xpert test, the latter of which can delay the administration of treatment and possible increase spread of HCV infection to other persons, and the former of which can lead to inappropriate diagnosis and unnecessary treatment. According to data published in Viruses in 2021 by Petroff et al, the Xpert test results were interpreted as false positive at a rate of 0.4% (95% CI 0.1 to 1.3%) among a cohort of 546 valid-tested patients.²

The Xpert test offers the advantage of working around the logistical challenges when central lab sample testing is required, as the Cepheid product can detect HCV RNA from a fingertip blood sample and deliver results in approximately 60 minutes. The FDA noted that this authorization allows for a “test-and-treat” method, in which individual can be tested for HCV, and, if positive for HCV RNA, can then be linked to care and potentially receive treatment all in a single visit—rapidly increasing the standard time frame for testing and care.

“[One-]third of people with hepatitis C in the United States don’t even know they have a deadly, yet curable, infection,” Jonathan Mermin, MD, MPH, the director of CDC’s National Center for HIV, Viral Hepatitis, STD and TB Prevention, said in a statement.¹ “This new test provides hope that more people will be cured, but it will only succeed if it is affordable and available.”

REFERENCES

1. FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test. News release. FDA. June 27, 2024. Accessed June 27, 2024. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test
2. Petroff D, Bätz O, Jedrysiak K, Kramer J, Berg T, Wiegand J. The Practicability of the Xpert HCV Viral Load Fingerstick Point-of-Care Assay in Primary Care Settings. Viruses. 2021;13(11):2327. doi:10.3390/v13112327