FDA grants PMA to Siemens Healthineers’ Versant HCV Genotype 2.0 Assay

21 March 2017 (Last Updated March 21st, 2017 18:30)

The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Siemens Healthineers' Versant HCV Genotype 2.0 Assay (LiPA) to detect Hepatitis C virus (HCV).

The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Siemens Healthineers' Versant HCV Genotype 2.0 Assay (LiPA) to detect Hepatitis C virus (HCV).

The simple, standardised assay is designed to identify and detect genotype and subtype of HCV.

Featuring a fully automated strip processing, the assay is claimed to improve lab efficiency and accuracy with an integrated system from nucleic acid extraction and amplification to interpretation.

"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."

Siemens Healthineers molecular diagnostics head Fernando Beils said: “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 US.

“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.”

The assay identifies the six genotypes as well as subtypes 1a and 1b, while the HCV core region inclusion enables precise differentiation of subtypes 1a and 1b, in addition to determination of genotype 6.

It also includes a simple, single-step RT-PCR kit that can be utilised on commonly available thermocyclers for easy use and enhanced laboratory efficiency.

The assay acts as an important tool to determine therapies for patients, as the existing treatment regimens are not effective on all HCV genotypes, and an assessment of HCV genotype, subtypes 1a or 1b is necessary.