Siemens Healthineers gets FDA premarket OK for hep C genotyping test
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. This means that determining genotype, as well as subtypes 1a or 1b, is important for planning patient therapy, Siemens explained. The assay provides flexible automation options to fit the needs and volume requirements of both small and large labs, the company added. “The FDA’s approval of our Versant HCV [assay], along with last year’s introduction of Versant kPCR sample prep at AACC, exemplifies Siemens Healthineers’ commitment to — and excitement about — molecular diagnostics in the US,” Siemens Healthineers Head of molecular diagnostics Fernando Beils said in a statement.