Siemens Healthineers Receives FDA Premarket Approval of HCV Genotyping Test for Hepatitis C Patients

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 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.

“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.,” says Fernando Beils, Head of Molecular Diagnostics, Siemens Healthineers. “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.”

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. These regimens can lead to a high rate of cured infections. Treatment regimens are not effective on all HCV genotypes; therefore, the HCV genotype , as well as subtypes 1a or 1b, must be assessed prior to treatment initiation, making the VERSANT HCV Genotype 2.0 Assay (LiPA) an important tool for physicians as they plan therapies for their patients.

For more information on VERSANT HCV Genotype 2.0 Assay (LiPA), click here.