Regulatory milestone validates the SOPHiA DDMTM Platform as diagnostic tool in select markets BOSTON and ROLLE, Switzerland , Aug. 14, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH ), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced that its SOPHiA DDMTM Platform is now CE marked under the European Union's In Vitro Diagnostic Regulation (IVDR). IVDR certification is a significant regulatory milestone that validates the powerful analytical capabilities of the SOPHiA DDMTM Platform and allows customers throughout the European Union and other markets recognizing this certification to use the SOPHiA DDMTM Platform to support patient diagnostics.
The transition from the In Vitro Diagnostic Directive (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 DDMTM.
"At SOPHiA GENETICS, certification of our SOPHiA DDMTM Platform under IVDR builds on our track record of offering a broad set of CE-IVD applications and giving our customers confidence in knowing they are using a cutting-edge, compliant Platform for their analysis needs,.