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

The FDA 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.1 These regimens can lead to a high rate of cured infections.2Treatment 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.3
2AASLD HCV Guidelines: Recommendations for Testing, Managing, and Treating Hepatitis C, 2016.
3AASLD HCV Guidelines: Recommendations for Testing, Managing, and Treating Hepatitis C, 2016.
Contact for journalists
Theresa Gombar, Siemens Healthineers
Phone: +1 610-448-6370;
E-mail: theresa.gombar@siemens-healthineers.com
Siemens Healthineers is the separately managed healthcare business of Siemens AG enabling healthcare providers worldwide to meet their current challenges and to excel in their respective environments. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular diagnostics. Siemens Healthineers is also actively developing its digital health services and enterprise services. To help customers succeed in today’s dynamic healthcare marketplace, Siemens Healthineers is championing new business models that maximize opportunity and minimize risk for healthcare providers. In fiscal 2016, which ended on September 30, 2016, Siemens Healthineers generated revenue of €13.5 billion and profit of over €2.3 billion and has about 46,000 employees worldwide. Further information is available at www.siemens.com/healthineers