SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company, has announced that its SOPHiA DDM Platform has been CE marked under the European Union's In Vitro Diagnostic Regulation (IVDR), a significant regulatory milestone. This certification endorses the platform's robust analytical capabilities and compliance with the latest European standards for genetic testing and analysis, solidifying its role in supporting patient diagnostics across the EU and other markets that recognize IVDR.

The IVDR certification ensures that the SOPHiA DDM Platform meets stringent requirements for in vitro diagnostic devices, reinforcing its reliability and accuracy in clinical settings. This transition from the previous In Vitro Diagnostic Directive (IVDD) to IVDR reflects a broader commient to transparency, traceability, and patient safety in genomic analysis. With this certification, SOPHiA GENETICS continues to empower healthcare providers with cutting-edge tools for cancer and other critical diagnoses.

The platform, powered by deep learning algorithms and a global network of partners, has already facilitated the analysis of over 1.7 million genomic profiles. As a result, healthcare professionals can now confidently rely on the SOPHiA DDM Platform for compliant, efficient, and precise diagnostics, particularly in oncology.