Cepheid's Xpert HCV test receives FDA De Novo authorization and CLIA Waiver for point-of-care hepatitis C diagnosis.

Cepheid's Xpert HCV test and GeneXpert Xpress System have received FDA De Novo marketing authorization and CLIA Waiver approval, marking the first rapid test for hepatitis C virus (HCV) in point-of-care settings. The test, performed on fingerstick samples, detects HCV RNA and provides results in about an hour. This allows healthcare providers to diagnose and treat patients in the same visit, potentially diagnosing and treating hundreds of thousands more hepatitis C patients, preventing disease progression and further virus spread.

June 27, 2024
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