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Sophia Genetics' DDM Platform Achieves CE Marking

NextEdge Admin

15 Aug 2024

2 min 51 sec

SOPHiA GENETICS , a cloud-native healthcare technology leader in data-driven medicine, announced that its SOPHiA DDM™ Platform has received CE marking under the European Union’s In Vitro Diagnostic Regulation (IVDR). This certification represents a major regulatory achievement, affirming the robust analytical capabilities of the SOPHiA DDM™ Platform and enabling its use across the European Union and other regions recognizing this certification to support patient diagnostics.

The transition from the In Vitro Diagnostic Directive (IVDD) to the IVDR in the European Union introduces enhanced regulatory standards for genetic testing and analysis, including the software used in these processes. The new standards emphasize transparency and traceability in genomic analysis, ensuring the reliability and accuracy of diagnostic results and ultimately enhancing patient safety. By utilizing IVDR-compliant software like the SOPHiA DDM™ Platform, users can benefit from time and cost savings.

“At SOPHiA GENETICS, achieving IVDR certification for our SOPHiA DDM™ Platform reinforces our commitment to providing a wide array of CE-IVD applications and instills confidence in our customers that they are using a state-of-the-art, compliant platform for their analytical needs,” said Daan Van Well, LL.M., M.B.A., Chief Legal and Compliance Officer at SOPHiA GENETICS. “This was a top priority for us, ensuring a seamless transition for our current CE-IVD customers so they can continue leveraging the SOPHiA DDM™ Platform for supporting diagnosis and treatment decisions in oncology.”

The IVDR certification confirms that the SOPHiA DDM™ Platform’s genetic analysis adheres to the European IVDR 2017/746 standards, governing the sale of in vitro diagnostic devices within the European Economic Area. The Platform, powered by SOPHiA GENETICS’ proprietary deep learning algorithms, supports advanced oncology technologies and has facilitated the analysis of over 1.7 million genomic profiles through its global network of partners.