NEW YORK — Dutch molecular diagnostics firm Genome Diagnostics said on Friday that it has received a European Union Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for its portfolio of human leukocyte antigen (HLA) products.
The portfolio includes GenDx's NGSgo reagents and NGSengine software for high-resolution HLA genotyping on next-generation sequencing platforms. HLA genotyping can help match patients and donors for stem cell transplantation. The notified body Tüv Süd certified GenDx’s HLA products are compliant with the IVDR, the company said.
The IVDR, a sweeping new system of regulations for in vitro diagnostic tests set to start taking effect later this month throughout much of Europe, establishes increased quality management, continuous evaluation during a product's life cycle, and more technical documentation to prove effectiveness for in vitro diagnostics in the EU, according to GenDx.
Earlier this year, a European Commission group issued new guidance to the IVDR covering high-risk tests.
"We are proud to be the first global supplier in the field of transplant diagnostics … able to offer a full HLA workflow portfolio under the new IVD Regulation," GenDx CEO Wietse Mulder said in a statement. "As a result, we can continue to provide our customers with certified products, claiming increased safety, and offer improved quality that will finally benefit transplant patients."