The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, a 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 healthcare visit.
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.
