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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SOURCE Golden Helix Inc