HELSINKI, Finland, December 2021. Euformatics, Finnish bioinformatics software company, has today announced that its genomic variant interpretation and reporting tool, omnomicsNGS, has been granted the CE-IVD mark under the In-Vitro Diagnostics Directive (98/79/EC). The software, previously a CE-marked medical device class I under preceding EU legislation, is now making strong progress on its journey to being a CE-marked clinical diagnostics tool under the binding upcoming In-Vitro Diagnostics Regulation.
By complying with the IVDD, Euformatics strengthens the position of omnomicsNGS in the clinical diagnostics market for NGS data, and further highlights the quality of the product primarily designed for clinical use. Available both as a cloud-based installation or locally on customer-defined hardware, the tool provides flexibility and security to clinical users of NGS data whatever their set-up. While the new CE-marking is valid in the EEA, its value is also recognised around the world.
The announcement further solidifies the company’s dedication to the quality of its products, including compliance with ISO 13485 which requires a strong quality management system for the operation of the whole company, including its product design and development. For clinical laboratories, the announcement means that omnomicsNGS becomes one of only a handful of products currently offered with a CE-IVD mark.
Euformatics Quality Engineer, Iina Kivimäki, says “The approval of omnomicsNGS as a CE-IVD device omnomicsNGS is a real milestone for us on our journey to becoming IVDR compliant. It highlights our commitment to providing the best-quality products to our customers while ensuring that the diagnostic results are traceable and reproducible. 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”.
The company also continues to be a strong force in the field of NGS data quality through its partnership started in 2015 with External Quality Assessment (EQA) providers EMQN and GenQA, both based in the UK. The 2021 EQA round for NGS closed to submissions last week, with more entries than ever before, a sign that quality in clinical NGS applications continues to grow in importance.
Euformatics is a Finnish software company that specialises in high standard bioinformatics tools for genomic data interpretation. Since 2010, Euformatics has been helping medical doctors and molecular genetics laboratories provide better precision medicine for cancer, common or rare disease diagnostics. At present, our core solution is the omnomics Suite which includes omnomicsNGS; for clinical analysis and reporting of patient NGS data, and omnomicsQ; for NGS data quality management.
For more information, please visit our website www.euformatics.com