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GenDx’ HLA typing products IVD registered at Health Canada

GenDx has completed IVD registration in Canada for two NGSgo products.

1)NGSgo®-AmpX v2for individual HLA gene amplification

2)NGSgo®-MX6-1for multiplexed amplification of six HLA genesin one tube

The amplification productscan be used to obtain high-resolution HLA genotyping information by means of downstream sequencing applications, and genotype analysis with IVD-registered NGS-engine® software.The completion of the registrationmakes NGSgo the firstIVD productlinein Canadathat issuitable for diagnostic NGS-basedHLA typing ofdonorsand patients in need of a stem cell transplantation.

NGSgo-AmpX v2 is the successor of the original NGSgo-AmpX, which is successfully being sold globally. Thisv2 product uses the same primer design, but has been optimized by a faster cycling protocol, colored primers for easier handling, and a convenient enzyme mastermix that requires fewer pipetting steps.

NGSgo-MX6-1is a more recently releasedmultiplex amplification strategy, that combines amplification primers of six HLA genes (HLA-A, B, C, DRB1, DQB1 and DPB1) in a single tube. The primer design is similar to the robust NGSgo-AmpX approach, resulting in a product that delivers high qualitydata, while the number of pipetting steps and hands-ontime are greatly reduced.

Wietse MulderPhD, CEO of GenDx, commented: “We have worked intensely to validate and document theseNGSgo products according to the Health Canada IVD regulation. It took a great deal of work to complete, and we are proud to bethe first supplier that can offer this IVD productfor the transplant communityin Canada. We believe the products will truly support better typing of the HLA genes.”

Source: GenDx (Press release)