NEW YORK (GenomeWeb) – GenDx announced that it has received Canadian ISO certification, enabling the firm to start the registration procedure for its Sanger and next-generation sequencing HLA reagents and software for diagnostic purposes in Canada.
Specifically, the Dutch molecular diagnostics firm said it received CAN/CSA ISO 13485:2003 certification, a standard that forms the basis for the Canadian Medical Devices Conformity Assessment System. The system was created by Health Canada and the Standards Council to implement Canada's medical devices regulations, Gendx noted.
The Canadian certification comes a few months after the firm received the CE mark for its NGSgo-AmpX for amplifying complete HLA genes for downstream sequencing, as well as an alliance with Pacific Biosciences to co-market products aimed at full-length HLA gene sequencing.
GenDx spun out from the University Medical Center in Utrecht, the Netherlands in 2005. It originally offered products in the area of sequence-based typing for transplantation, but has expanded into next-generation sequencing and now provides products, services, and software using both conventional Sanger-based methods and next-gen sequencing.