SOPHiA GENETICS has been granted the CE marking under the EU's In Vitro Diagnostic Regulation (IVDR) for its SOPHiA DDM Platform. IVDR certification is a key regulatory requirement that allows the use of the SOPHiA DDM Platform in patient diagnostics across the EU and other markets recognizing this certification.

The platform leverages SOPHiA GENETICS' AI-based learning algorithms and reportedly includes five existing CE-IVD applications, a global network of partners for collective intelligence, and the successful analysis of more than 1.7 million genomic profiles. It analyzes and interprets raw data using next-generation sequencing (NGS) to provide reliable HRD results for personalized oncology treatment planning.

Analyst QuickTake: SOPHiA DDM (Data-driven Medicine) is a cloud-based platform that provides advanced data analysis solutions for healthcare institutions. The platform uses AI and ML to analyze complex genomic data, supporting a range of applications including oncology, hereditary disorders, and infectious diseases. Initially launched as a research tool for hospitals and research labs, the platform has expanded its capabilities, with its most recent addition being a residual acute myeloid (RAM) application, which was launched in June 2024 to strengthen the company's oncology portfolio with measurable residual disease (MRD) testing capabilities.