SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced that its SOPHiA DDM™ 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 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 (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™.
“At SOPHiA GENETICS, certification of our SOPHiA DDM™ 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,” said Daan Van Well, LL.M., M.B.A., Chief Legal and Compliance Officer SOPHiA GENETICS. “This was a top priority for our team to ensure a seamless transition for our current CE-IVD customers so they can continue to use the SOPHiA DDM™ Platform to support diagnosis and treatment decisions for patients facing cancer.”
The IVDR registration certifies that the SOPHiA DDM™ Platform’s genetic analysis meets the European IVDR 2017/746 requirements, which govern the sale of in vitro diagnostic devices within the European Economic Area. The SOPHiA DDM™ Platform offers “Dx Mode” in order to satisfy IVDR requirements.
Powered by SOPHiA GENETICS’ proprietary deep learning algorithms, the SOPHiA DDM™ Platform supports state-of-the-art oncology technologies, including five existing CE-IVD SOPHiA DDM™ applications. The Platform uses the collective intelligence gathered by SOPHiA GENETICS’ global network of partners and, to date, has facilitated the analysis of more than 1.7 million genomic profiles.
