Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C. The test may be performed in settings operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments and urgent care clinics. Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip, The authorization of this test enables a test-and-treat approach where a person can be tested for HCV, and if positive for HCV RNA, be linked to care and potentially receive treatment during the same health care visit. Prior to the availability of a rapid, point-of-care test, HCV testing has been a multi-step process which often results in patients needing follow-up appointments for test results and additional testing, which can lead to patients not receiving a diagnosis and not receiving necessary treatment.
According to the U.S. Centers for Disease Control and Prevention, hepatitis C is a liver infection caused by the hepatitis C virus. Hepatitis C is spread through contact with blood from a person with hepatitis C. For some people, hepatitis C is a short-term illness, but for more than half of people with HCV infection, it becomes a long-term, chronic infection, It is estimated more than 2.4 million people – and as many as 4 million people – in the United States have hepatitis C, which if left untreated, often leads to serious and sometimes deadly outcomes such as liver cancer and liver failure. The infection contributed to more than 12,000 deaths in 2022 alone.
Validation data for the Xpert HCV test and GeneXpert Xpress System was gathered through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program, in collaboration with the FDA. ITAP was launched in 2021 to accelerate test evaluation to support the FDA’s regulatory review and the availability of high-quality, accurate and reliable diagnostic tests to the public.
The test is indicated for adults with signs or symptoms of, or at risk for hepatitis C and is not intended for use in monitoring patients undergoing treatment or for use in screening blood, plasma or tissue donors. The risks associated with the test include the possibility of false positive and false negative test results. False negative test results can delay effective treatment and potentially increase spread of infection to other persons throughout the community. False positive results could lead to an inappropriate diagnosis of, and unnecessary treatment for hepatitis C. This could cause psychological distress and delay receiving a correct diagnosis, in addition to the expense and risk of side effects from unnecessary treatment.
The FDA reviewed the Xpert HCV test and GeneXpert Xpress System under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.
Learn more at: FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test | FDA
