Cepheid Xpert HCV gets FDA authorization, waiver

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July 2, 2024—Cepheid has received FDA de novo marketing authorization and CLIA waiver approval for its Xpert HCV, the first point-of-care hepatitis C RNA test. The test can accurately detect active HCV infection from people at risk and/or with signs and symptoms of HCV infection with or without antibodies to HCV from a capillary blood sample.

“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,” Vitor Rocha, president of Cepheid, said in a press statement.