Siemens Healthineers Gets FDA Premarket Approval for HCV Genotyping Test | GenomeWeb

NEW YORK (GenomeWeb) – Siemens Healthineers said today that the US Food and Drug Administration has granted the company a premarket approval for its Versant HCV Genotype 2.0 assay. According to the firm, the Versant test uses a single-step RT-PCR kit that can be run on commonly available thermocyclers. It identifies all six hepatitis C virus genotypes as well as subtypes 1a and 1b. Although effective HCV treatment regimens are available, they are not effective on all HCV genotypes.

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