Skip to main content
Premium Trial:

Request an Annual Quote

Golden Helix Gets CE Mark for Genetic Analysis Software

NEW YORK — Bioinformatics firm Golden Helix said Tuesday that it has received CE marking for its VarSeq Suite genetic analysis platform.

VarSeq, launched in 2014, is a software package that enables variant analysis for gene panels, exomes, and whole genomes. In November, Golden Helix released a version of the software that includes an advanced oncogenicity classifier algorithm.

According to the Bozeman, Montana-based company, the CE mark certifies that VarSeq meets the European In Vitro Diagnostic Regulation requirements that govern the sale of in vitro diagnostic devices within the European Economic Area. The software, Golden Helix noted, must be operated in Dx Mode to satisfy these requirements.

"Obtaining the CE mark is a pivotal step for Golden Helix as we expand internationally," Golden Helix President and CEO Andreas Scherer said in a statement.

Earlier this year, Golden Helix received ISO 13485:2016 certification, an international standard that specifies requirements for a quality management system for organizations involved in the design, development, product, and servicing of medical devices.