Cepheid, a molecular diagnostics company within Danaher, has received the US Food and Drug Administration (FDA) De Novo marketing authorisation for its Xpert HCV test.
Xpert HCV is a molecular diagnostic test that runs on the GeneXpert Xpress System to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample.
It is indicated for use in adults with symptoms of hepatitis C and is not intended for monitoring patients undergoing treatment or screening blood, plasma or tissue donors.
The molecular diagnostics company also received the Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for its hepatitis C test.
It allows the test to be performed in labs operating under a CLIA Certificate of Waiver, such as doctor’s offices, emergency departments and urgent care clinics, among others.
Also, the test doesn’t require a sample to be sent to a central lab for testing but detects HCV RNA and delivers results within an hour using a blood sample from the fingertip.
Cepheid chief medical and scientific officer David H Persing said: “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.”
Cepheid president Vitor Rocha said: “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.”
According to the company, the current clinical care pathway for detecting hepatitis C has many barriers, including complicated algorithms and RNA confirmation.
The algorithms need centralised testing technologies that may delay the treatment and discourage at-risk populations from accessing testing and receiving care.
Cepheid said its Xpert HCV test can accurately detect active HCV infection from at-risk individuals or those with signs and symptoms of HCV infection, regardless of antibodies to HCV.
The US health regulator said that Xpert HCV is the first hepatitis C virus test that can be used to bring diagnosis to certified point-of-care (POC) settings for individuals at risk for hepatitis C.
FDA’s Center for Devices and Radiological Health director Jeff Shuren said: “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.”
