July 1, 2024 – Cepheid introduced that it has acquired FDA De Novo Advertising and marketing Authorization and Medical Laboratory Enchancment Amendments (CLIA) Waiver Approval for Xpert^® HCV, the one molecular take a look at within the U.S. that immediately detects hepatitis C virus RNA from a human capillary entire blood specimen (fingerstick). The Xpert HCV take a look at runs on the GeneXpert Xpress System.

An estimated 2.4 million individuals in the USA live with hepatitis C, and greater than half of individuals with HCV are unaware they’ve the virus. Level-of-care HCV RNA testing can simplify testing algorithms, enhance analysis charges, and help well timed linkage to care and remedy.

The Viral Hepatitis Nationwide Strategic Plan for the USA requires greater than 80% of individuals with hepatitis C to attain viral clearance by 2030. At the moment, the medical care pathway for hepatitis C detection has many obstacles, together with difficult multi-step diagnostic algorithms primarily based on antibody screening and RNA affirmation³These algorithms require centralized testing applied sciences that may result in remedy delays and loss to follow-up and should forestall at-risk teams from present process testing and receiving care. Xpert^® HCV can precisely detect energetic HCV an infection in people in danger and/or displaying indicators and signs of HCV an infection, with or with out antibodies to HCV from a capillary blood pattern.

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