FDA has granted premarket approval for the Versant HCV Genotype 2.0 line probe assay (LiPA) from Siemens Healthineers.

A simple, standardized method for hepatitis C virus genotype and subtype detection and identification, the assay aims to improve lab efficiency and accuracy with fully automated strip processing and an integrated system from nucleic acid extraction and amplification to interpretation.

The assay provides flexible automation options to fit the needs and volume requirements of small and large labs. The assay identifies all six HCV 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. A single-step real-time polymerase chain reaction kit that can be used on commonly available thermocyclers seeks to provide ease-of-use and increased laboratory efficiency.

Fernando Beils, Siemens Healthineers.

Fernando Beils, Siemens Healthineers.

“FDA’s approval of our Versant HCV Genotype 2.0 assay (LiPA), along with last year’s introduction of [the] Versant kPCR sample prep at the American Association for Clinical Chemistry [scientific meeting], exemplifies Siemens Healthineers’ commitment to—and excitement about—molecular diagnostics in the United States,” says Fernando Beils, head of molecular diagnostics at 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.”

An estimated 150 million people are chronically infected with HCV worldwide, even though highly efficacious HCV treatment regimens—including direct antiviral agents—are now available.1 Such treatments can lead to a high rate of cured infections.2 However, current treatment regimens are not effective on all HCV genotypes; prior to initiating treatment, it is therefore necessary to identify the patient’s HCV genotype, as well as subtypes 1a or 1b.2

For more information, visit Siemens Healthineers.

References

  1. Hepatitis C [online]. Geneva: World Health Organization, 2017. Available at: who.int/mediacentre/factsheets/fs164/en/. Accessed March 27, 2017.
  2. HCV guidance: recommendations for testing, managing, and treating hepatitis C [online]. Alexandria, Va, and Arlington, Va: the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, 2017. Available at: www.hcvguidelines.org. Accessed March 27, 2017.