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GenDx Gets CE Mark for HLA Typing Products

NEW YORK – Genome Diagnostics (GenDx) announced Thursday that it has completed CE marking of its NGSgo-MX6-1 and NGSgo-AmpX v2 HLA typing products.

NGSgo-MX6-1 is a newly developed multiplex amplification strategy combining amplification primers for six HLA genes in a single tube: HLA-A, B, C, DRB1, DQB1 and DPB1. According to the Utrecht, Netherlands-based firm, the product greatly reduces the number of pipetting steps and hands-on time.

The NGSgo-AmpX v2 product is the next-generation version of the firm's NGSgo-AmpX product. It uses the same primer design of the first version, but the oligonucleotides are aliquoted using a new matrix that enhances the stability of the product, and a visible orange color facilitates easier handling, GenDx said. In addition, the kit includes the mastermix enzyme GenDx-LongMix, which the company said significantly reduces the time of the amplification procedure.

GenDx also noted that it is currently finishing an early-access program for its NGSgo-MX11-3 amplification strategy, which combines 11 HLA genes in three separate tubes. It said that product will provide whole-gene coverage of the relevant HLA genes. GenDx aims to obtain CE marking for that product in the third quarter of this year.