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GenDx Gets Health Canada Approval for HLA Genotyping Test

NEW YORK — Dutch molecular diagnostics firm Genome Diagnostics (GenDx) said on Friday that it has received approval from Canadian regulators for the in vitro diagnostic use of its NGSgo-MX11-3 human leukocyte antigen genotyping test.

NGSgo-MX11-3 provides multiplexed genotyping of 11 HLA loci, using next-generation sequencing and the company's NGSengine software. The genotyping data can be used to help match patients and donors for stem cell transplantation.

Last year, Utrecht-based GenDx received approval from Health Canada for IVD use of two other HLA genotyping tests: NGSgo-AmpX v2 for individual HLA gene amplification and NGSgo-MX6-1 for multiplexed amplification of six HLA genes.

"This latest addition of MX11-3 fits into the trend of applying multiplexed amplification and sequencing of 11 HLA genes of every patient and donor in a single run," GenDx CEO Wietse Mulder said in a statement.