Software firm Sophia Genetics has received the CE Mark under the European Union's (EU) In Vitro Diagnostic Regulation (IVDR) for its Sophia DDM platform.
Sophia DDM is a cloud-based platform powered by Sophia Genetics' proprietary deep-learning algorithms that analyze genomic and multimodal clinical data to support healthcare providers and researchers in both patient care and drug development. To satisfy the EU's IVDR requirements, the platform offers a diagnosis (Dx) mode.
The company noted in a statement that the platform uses oncology technologies, including five CE-IVD Sophia DDM applications, and the collective intelligence gathered by the company's global network of partners. To date, the platform has facilitated the analysis of more than 1.7 million genomic profiles, according to the firm.
"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," Daan van Well, chief legal and compliance officer at Sophia Genetics, said in the firm's statement.
