Sophia Genetics announces CE mark for Sophia DDM Platform under IVDR

Sophia Genetics announced that its Sophia DDM Platform is now CE marked under the European Union’s In Vitro Diagnostic Regulation, or IVDR. IVDR certification is a significant regulatory milestone that validates the powerful analytical capabilities of the Sophia DDM Platform and allows customers throughout the European Union and other markets recognizing this certification to use the Sophia DDM Platform to support patient diagnostics. The transition from the In Vitro Diagnostic Directive, or IVDD, to the IVDR in the European Union marks an important advancement in regulatory standards for genetic testing and analysis, including software used for analysis. The new standards promote transparency and traceability throughout genomic analysis processes, helping to ensure the reliability and accuracy of diagnostic results and ultimately patient safety. Users can save time and costs by leveraging an IVDR compliant software platform, like Sophia DDM.