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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

Driving Malaria-Carrying Mosquitoes Down

Researchers from the UK and Italy have tested a gene drive for mosquitoes to limit the spread of malaria, NPR reports.

Office Space to Lab Space

The New York Times writes that some empty office spaces are transforming into lab spaces.

Prion Pause to Investigate

Science reports that a moratorium on prion research has been imposed at French public research institutions.

Genome Research Papers on Gut Microbe Antibiotic Response, Single-Cell RNA-Seq Clues to Metabolism, More

In Genome Research this week: gut microbial response to antibiotic treatment, approach to gauge metabolic features from single-cell RNA sequencing, and more.