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Devyser's Fetal Test Gains IVDR Certification

The story has been corrected. It previously incorrectly said that Devyser's aneuploidy test can be used to detect aneuploidy in fetal cells circulating in maternal blood.

NEW YORK — Swedish diagnostics company Devyser said on Monday that its quality management system and fetal diagnostics product have been certified under Europe's new In Vitro Diagnostic Regulation.

Europe recently transitioned to the new regulation, which requires most molecular tests to be certified by a designated organization, called a notified body. Munich, Germany-based TÜV Süd issued Devyser's certificate, the Stockholm-based company said.

CEO Fredrik Alpsten said that Devyser has worked for years to meet IVDR regulations, and that the certification "shows that Devyser has a development and quality organization that can compete with the best in Europe."

Devyser develops and markets genetic testing kits used for advanced DNA testting in the hereditary disease, oncology, and transplant fields.