Golden Helix, Inc., a leading provider of clinical bioinformatics solutions, is pleased to announce that it has received CE mark approval for its genetic analysis platform VarSeq Suite. This significant regulatory milestone paves the way for the expansion of Golden Helix’s advanced genetic analytics products to the European market, ensuring compliance with the European Union’s health, safety, and environmental protection standards.
The CE mark certifies that Golden Helix’s genetic analysis platform meets the European In Vitro Diagnostic Regulation (IVDR 2017/746) requirements, which govern the sale of in vitro diagnostic devices within the European Economic Area (EEA). The software must be operated in “Dx Mode” to satisfy the IVDR requirements. Customers will receive specific instructions on how to switch on this compliance mode. With this certification, Golden Helix is poised to assist healthcare providers across Europe in delivering personalized medical diagnostics.
“Obtaining the CE mark is a pivotal step for Golden Helix as we expand internationally,” said Dr. Andreas Scherer, President and CEO of Golden Helix. “This approval not only demonstrates our commitment to compliance and quality. It enhances our ability to serve healthcare providers with advanced genetic testing solutions that improve patient outcomes.”
Golden Helix’s genetic analysis platform is renowned for its robust analytical capabilities, enabling the accurate interpretation of genetic variations that are critical for the diagnosis and treatment of hereditary diseases and cancer. With features designed to streamline workflows and enhance diagnostic accuracy, the platform is an essential tool for geneticists, pathologists, and clinicians working in the field of personalized medicine.
This news follows an announcement earlier this year that Golden Helix received its ISO 13485:2016 certification for its Medical Device and Quality Management System.
