FDA premarket approval of HCV genotyping test for Hepatitis C patients

HCV infection is a serious public health problem, with an estimated 150 million people chronically infected worldwide, even though highly efficacious HCV treatment regimens—including direct antiviral agents (DAA)—are now available.

The Food and Drug Administration has granted Premarket Approval for the VERSANT HCV Genotype 2.0 Assay (LiPA) from Siemens Healthineers.

A simple, standardised method for HCV (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.

With products and solutions such as the VERSANT HCV Genotype 2.0 Assay (LiPA), as well as a new name that underlines the company’s pioneering spirit and its engineering expertise in the healthcare industry, Siemens Healthineers – the separately managed healthcare business of Siemens AG – is setting new trends in healthcare, helping to enable healthcare providers around the world to meet their current challenges and to excel in their respective environments.

The VERSANT HCV Genotype 2.0 Assay (LiPA) provides enhanced confidence in results, and flexible automation options provide a solution that fits the needs and volume requirements of small and large labs alike.

The VERSANT HCV Genotype 2.0 Assay (LiPA) identifies all 6 genotypes and subtypes 1a and 1b. In particular, the inclusion of the HCV Core region allows for accurate differentiation of subtypes 1a and 1b, as well as determination of genotype 6.

Finally, a simple, single-step RT-PCR kit that can be used on commonly available thermocyclers provides ease-of-use and increased laboratory efficiency.

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