Siemens’ HCV genotype test receives PMA
April 11, 2017—The Food and Drug Administration has granted premarket approval for the Versant HCV Genotype 2.0 Assay (LiPA) from Siemens Healthineers. A simple, standardized method for hepatitis C virus genotype and subtype identification and detection, the Versant HCV Genotype 2.0 Assay (LiPA) improves lab efficiency and accuracy with fully automated strip processing and an integrated system from nucleic acid extraction and amplification to interpretation.
The Versant HCV Genotype 2.0 Assay (LiPA) identifies all six genotypes and subtypes 1a and 1b. The inclusion of the HCV core region allows for accurate differentiation of subtypes 1a and 1b as well as determination of genotype 6. The single-step RT-PCR kit can be used on commonly available thermocyclers.
“The FDA’s approval of our Versant HCV Genotype 2.0 Assay (LiPA), 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 U.S.,” Fernando Beils, head of Molecular Diagnostics, Siemens Healthineers, said in a company statement. “These products, which include the world’s most widely used HCV genotyping assay, will guide physicians in planning the most effective method of antiviral therapy for patients with Hepatitis C infections.”