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Euformatics Gains CE-IVD Mark for OmnomicsNGS

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."

The Scan

For STEM Students to Stay

New policy changes will make it easier for international STEM students to stay in the US after graduation, the Wall Street Journal reports.

To Inform or Not, To Know or Not

The New York Times writes that some genetic biobanks may re-contact donors if they spot something troublesome, but it notes that not all donors want that information.

Rapid Test Studies

Researchers are examining why rapid tests may be less effective at detecting the Omicron variant and how to improve them, NPR says.

PLOS Papers on SARS-CoV-2 Diversity in Delaware, Metastatic Breast Cancer, Adiposity GWAS

In PLOS this week: genomic analysis of SARS-CoV-2 isolates from Delaware, gene expression and protein-protein interaction patterns in metastatic breast cancer, and more.