NEW YORK – Sophia Genetics said that it has received CE-IVD marking for analytics functionality of its core Sophia Data Driven Medicine (DDM) software platform. The Swiss-American firm made the announcement Tuesday at the European Society of Human Genetics conference in Vienna.
The new CE-IVD marking covers two specific applications, namely the Sophia DDM Dx Homologous Recombination Deficiency (HRD) Solution and RNAtarget Oncology Solution. Sophia previously earned CE marks for its Hereditary Cancer Solution, for genetic testing of familial Mediterranean fever and hypercholesterolemia, and for its next-generation sequencing bioinformatics pipeline.
The company said that the new certification means that Sophia DDM is now "IVD-ready to support all applications and modules designed for diagnostic purposes" in the EU and other countries that recognize the CE mark.
"The CE-IVD certification for these IVD applications is a milestone that reflects the quality and reliability of our Sophia DDM platform," Cofounder and CEO Jurgi Camblong said in a statement. "This will help us meet the needs of our healthcare partners in the EU who want to implement Sophia Genetics' proprietary algorithms for clinical use."