Cepheid has earned U.S. Food and Drug Administration (FDA) de novo authorization and CLIA Waver approval for Xpert HCV, a molecular test to spot hepatitis C RNA from a fingerstick sample.
The test, which is performed on the GeneXpert Xpress system, detects the hepatitis C virus (HCV) in about an hour, according to the company. It can accurately spot active HCV infection from those at risk and/or with signs and symptoms of infection with or without antibodies to HCV from a capillary blood sample.
"This simple to use test detects the full range of known HCV genotypes in about an hour and can be performed on a small volume of blood collected via fingerstick," said David H. Persing, MD, Ph.D., Cepheid's chief medical and scientific officer.
"This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care. This enables diagnosis of HCV and facilitates timely linkage to care within a single clinic visit—and with this, the potential for treating more people with HCV," added Vitor Rocha, president of Cepheid.
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.
This test’s authorization of this test allows 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.
Before the availability of a rapid, point-of-care test, HCV testing has been a multi-step process where patients often need follow-up appointments for test results and additional testing, which can lead to not receiving a diagnosis and receiving necessary treatment.
“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,” said Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health. “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.”