NEW YORK – Euformatics said Friday that it has received a CE-IVD mark for its OmnomicsNGS variant interpretation and reporting software. The technology previously had CE marking as a Class I medical device under earlier European Union rules.
The Finnish firm said that the new designation improves the market position of the software in the clinical diagnostics market for next-generation sequencing data, particularly with the EU's In Vitro Diagnostics Regulation on the horizon.
"The approval of OmnomicsNGS as a CE-IVD device … is a real milestone for us on our journey to becoming IVDR-compliant," Iina Kivimäki, Euformatics' quality engineer, said in a statement. "As NGS technologies continue to make a positive impact on the way we treat diseases and NGS-based testing gains further traction globally, we want to be at the forefront of providing the software tools needed to get the most out of the data."