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GenDx HLA Genotyping Products Receives Health Canada IVD Approval

NEW YORK – Genome Diagnostics, the Dutch molecular diagnostics company also known as GenDx, said this week that two of its next-generation sequencing products for human leukocyte antigen typing have received medical device licenses from Health Canada for in vitro diagnostic use.

The products — NGSgo-AmpX v2 for individual HLA gene amplification and NGSgo-MX6-1 for multiplexed amplification of six HLA genes — combine sequencing and analysis with the company's CE marked NGSengine software to provide high-resolution HLA genotyping information, which is used to match patients and donors for bone marrow or cord blood transplants.

GenDx, based in Utrecht, said that NGSgo-AmpX v2 builds upon its CE marked NGSgo-AmpX product, which is compatible with Illumina MiSeq sequencers. It uses the same primer design as the first version of the assay, but has been optimized with a faster cycling protocol, colored primers, and an enzyme mastermix requiring fewer pipetting steps.

Meanwhile, NGSgo-MX6-1 combines amplification primers for six HLA genes (HLA-A, B, C, DRB1, DQB1, and DPB1) in a single tube.

"We have worked intensely to validate and document these NGSgo products according to the Health Canada IVD regulation," GenDx CEO Wietse Mulder said in a statement. "It took a great deal of work to complete, and we are proud to be the first supplier that can offer this IVD product for the transplant community in Canada. We believe the products will truly support better typing of the HLA genes."