CLN Article

Siemens Receives FDA Approval for HCV Genotyping Assay

Regulatory Roundup: May 2017

The Food and Drug Adminis­tra­tion has approved the Versant HCV Genotype 2.0 assay (LiPA) from Siemens Healthineers. A second generation line probe assay, this test analyzes both the noncoding and core regions of the hepatitis C virus (HCV) genome to identify all six HCV genotypes and differentiate between subtypes 1a and 1b. Compared with direct sequence analysis of the NS5B region—the reference method Siemens used for validation—the Versant HCV Genotype 2.0 assay mistypes only 4% of clinical specimens. Healthcare providers will be able to use this test to tailor peginterferon-ribavirin treatment dose and duration according to HCV genotype. The test’s ability to determine subtype might also be used in the near future to tailor specific HCV inhibitor therapy and interpret resistance profiles. The Versant HCV Genotype 2.0 includes a single-step reverse transcription polymerase chain reaction kit that can be used on commonly available thermocyclers. It also features fully automated strip processing and an integrated system from nucleic acid extraction and amplification to interpretation. 

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