FDA Grants Marketing Authorization for Rapid Hepatitis C Test


The test can be performed in settings that operate under the Clinical Laboratory Improvement Amendments waiver, including community pharmacies.

The FDA has granted marketing authorization for Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used as a point-of-care option for patients to test for HCV. The test can detect HCV RNS and deliver results in approximately 1 hour from a blood sample.1

Hepatitis C | Image Credit:  bluebay2014 - stock.adobe.com

Image Credit: bluebay2014 - stock.adobe.com

The test can be performed in settings that operate under the Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, including physician’s offices, emergency departments, urgent care clinics, and community pharmacies.1

“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,” Jeff Shuren, MD, JD, director of the Center for Devices and Radiological Health at the FDA, said in a news release. “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.”1

HCV can be spread through contact with infected blood, due to the sharing of needles and syringes or through unsafe blood transfusions. In the first weeks of infection, most individuals do not experience symptoms and it could take approximately 2 to 6 months before symptoms appear. Because HCV can be asymptomatic, few individuals are diagnosed early when infected, causing it to be under diagnosed until liver damage is caused. According to the World Health Organization, early diagnosis can prevent health issues and prevent the transmission of the virus, and the agency recommends those who may be at increased risk of infection be tested.2

The test is indicated for adults with signs and symptoms of HCV or at risk for infection and is not intended to monitor patients undergoing treatment or for screening of blood donors. If positive, the patient can be linked to care and individuals could receive treatment during the same health care visit.1

In a study published in Viruses, the test was valid in approximately 87.8% of patients who were recruited. The study authors recruited 622 individuals for the study, with 5 individuals who were anti-HCV positive and 1 who was HCV-RNA positive. It was reported that 2 patients had false positive readings in the study. In a survey of physicians, 81% rated the test as good and 13% rated it as satisfactory.3

In a review published in Exploratory Research in Clinical and Social Pharmacy, the authors discussed the CLIA certificate of waver, which can allow pharmacies and pharmacists to handle and analyze human specimens as long as they meet prespecified criteria. Laboratories operating under CLIA waivers need to have a certificate of compliance, certificate for provider-performed microscopy, a certificate of accreditation, certificate of registration, and certification of waiver, according to the authors. CLIA plays an important role for pharmacies to offer clinical services to improve health and care for patients.4

The authors also stated that pharmacies in the United States are the fourth largest entity to hold certificates of waivers for CLIA testing, with approximately 17.94%of pharmacies holding certificates. However, regulations and legislation at the state level could complicate how many pharmacies operate under CLIA; therefore, pharmacists should be up to date with their state laws and regulations.4

1. FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test. News release. FDA. June 27, 2024. Accessed July 2, 2024. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test
2. World Health Organization. Hepatitis C. April 9, 2024. Accessed July 2, 2024. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
3. 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. Published 2021 Nov 22. doi:10.3390/v13112327
4. Doucette J, Lavino J. Ability of community pharmacists to independently perform CLIA-waived testing - A multistate legal review. Explor Res Clin Soc Pharm. 2021;2:100024. Published 2021 May 8. doi:10.1016/j.rcsop.2021.100024
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