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Siemens Healthineers Gets FDA Premarket Approval for HCV Genotyping Test

NEW YORK (GenomeWeb) – Siemens Healthineers said today that the US Food and Drug Administration has granted the company a premarket approval for its Versant HCV Genotype 2.0 assay. According to the firm, the Versant test uses a single-step RT-PCR kit that can be run on commonly available thermocyclers. It identifies all six hepatitis C virus genotypes as well as subtypes 1a and 1b. Although effective HCV treatment regimens are available, they are not effective on all HCV genotypes. This means that determining genotype, as well as subtypes 1a or 1b, is important for planning patient therapy, Siemens explained. The assay provides flexible automation options to fit the needs and volume requirements of both small and large labs, the company added. "The FDA's approval of our Versant HCV [assay], 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,” Siemens Healthineers Head of molecular diagnostics Fernando Beils said in a statement.

The Scan

Genes Linked to White-Tailed Jackrabbits' Winter Coat Color Change

Climate change, the researchers noted in Science, may lead to camouflage mismatch and increase predation of white-tailed jackrabbits.

Adenine Base Editor Targets SCID Mutation in New Study

Researchers from the University of California, Los Angeles, report in Cell that adenine base editing was able to produce functional T lymphocytes in a model of severe combined immune deficiency.

Researchers Find Gene Affecting Alkaline Sensitivity in Plants

Researchers from the Chinese Academy of Science have found a locus affecting alkaline-salinity sensitivity, which could aid in efforts to improve crop productivity, as they report in Science.

International Team Proposes Checklist for Returning Genomic Research Results

Researchers in the European Journal of Human Genetics present a checklist to guide the return of genomic research results to study participants.