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FDA Grants CLIA Waiver to Cepheid for Xpert® HCV

NextEdge Admin

28 Jun 2024

2 min 45 sec

Cepheid has recently secured FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert® HCV, a groundbreaking molecular test in the United States designed to detect hepatitis C virus RNA directly from capillary whole blood samples obtained via fingerstick. The Xpert HCV test operates on the GeneXpert Xpress System, offering rapid results in approximately one hour.

This approval is significant as it addresses a critical need in public health. In the US, an estimated 2.4 million individuals live with hepatitis C, with more than half unaware of their infection status. Traditional diagnostic approaches involve complex multi-step algorithms relying on antibody screening and RNA confirmation, often leading to delays in treatment initiation and patient follow-up.

Xpert® HCV simplifies this process by allowing for immediate RNA detection of HCV, regardless of antibody presence, directly at the point of care. This capability not only streamlines testing protocols but also enhances diagnosis rates and facilitates prompt linkage to necessary healthcare services. The technology is capable of identifying all known HCV genotypes, ensuring comprehensive coverage in clinical settings.

David H. Persing, M.D., Ph.D., Chief Medical and Scientific Officer at Cepheid, highlighted the test's ease of use and rapid turnaround time, emphasizing its potential to expand access to care and improve treatment outcomes. Vitor Rocha, President of Cepheid, underscored the test's role in enabling active case finding and immediate care linkage within a single clinical visit.

Cepheid, based in Sunnyvale, California, is a leading molecular diagnostics company under Danaher Corporation's Diagnostics platform. Their commitment to developing user-friendly molecular systems aims to revolutionize healthcare delivery by automating complex genetic testing processes, thereby enhancing diagnostic accuracy and patient care.