GenDx Receives Approval in Canada for Its HLA Genotyping Test

Genome Diagnostics (GenDx) has received Health Canada’s approval for its NGSgo-MX11-3 genotyping test for in vitro diagnostic use as an aid in matching donors and patients for stem cell transplantation.

To ensure a close donor match, the test uses next-generation sequencing and the firm’s proprietary software for genotyping of 11 separate human leukocyte antigen (HLA) genes.

This marks the company’s third in vitro test approval by the Canadian authority. Last year, it was granted approval for its NGSgo-MX6-1 for amplification of six HLA genes and its NGSgo-AmpX v2 for individual HLA gene amplification.