BOZEMAN, Mont., May 7, 2024 /PRNewswire/ -- 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.
About Golden Helix
Golden Helix has been delivering industry-leading bioinformatics solutions for over a quarter century with thousands of users worldwide. Golden Helix enables hospitals, testing labs, research institutions, and country-wide genome initiatives to conduct a wide spectrum of clinical tests and facilitate genomic research. With its solutions, Golden Helix users can harness the full potential of genomics to identify the cause of disease, gain diagnostic insights, and improve the efficacy and safety of drug treatments advancing the quest for personalized medicine. Since 2017, the company has received a total of $4 million in funding from the NIH.
Casey Fullem
Director of Marketing
Golden Helix, Inc
(406) 551-4901
fullem@goldenhelix.com
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