Secured CE Mark for the European Union 

         May 7, 2024

We are pleased to announce that Golden Helix has received CE mark approval for its genetic analysis platform VarSeq Suite. This significant regulatory milestone paves the way for the expansion of our advanced genetic analytics products to the European market, ensuring compliance with the European Union’s health, safety, and environmental protection standards. 

Receiving the CE mark certifies that our VarSeq Suite meets the requirements set by the European In Vitro Diagnostic Regulation (IVDR 2017/746), which governs the sale of in vitro diagnostic devices across the European Economic Area (EEA). To comply with these regulations, our software operates 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.

This certification not only highlights our commitment to regulatory compliance and quality but also enhances our capacity to support healthcare providers throughout Europe in delivering personalized medical diagnostics. Our platform is renowned for its robust analytical capabilities, enabling precise interpretation of genetic variations essential for diagnosing and treating hereditary diseases and cancer. Designed to streamline workflows and boost diagnostic accuracy, the VarSeq Suite is an indispensable tool for geneticists, pathologists, and clinicians dedicated to the field of personalized medicine.

Earlier this year, we also received ISO 13485:2016 certification for our Medical Device and Quality Management System. These achievements collectively underscore our commitment to excellence and our dedication to improving patient outcomes through advanced genetic testing solutions. As we continue to grow and expand internationally, we remain focused on developing technologies that meet the highest standards of quality and safety, helping transform healthcare’s future through innovative genetic analysis.

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