GenDx completes CE marking of NGS HLA typing products

GenDx has successfully completed the CE marking of their In Vitro Diagnostics (IVD) HLA typing products NGSgo-MX6-1 and NGSgo-AmpX v2.

NGSgo-AmpX v2
NGSgo-AmpX v2 is the successor of the also CE-marked original version NGSgo-AmpX, which is being successfully sold globally. The v2 product uses the same primer design, however, the oligonucleotides are aliquoted using a new matrix that enhances the stability of product, and a visible orange color facilitates easier handling. The kit now includes the accessory mastermix enzyme GenDx-LongMix, which significantly reduces the time of the amplification procedure.

NGSgo-MX6-1
NGSgo-MX6-1 is a newly developed multiplex 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 very similar to the robust NGSgo-AmpX approach, resulting in a product that is high in quality, while the number of pipetting steps and hands-on time are greatly reduced.

GenDx is currently finishing the early access program (EAP) of the new NGSgo-MX11-3 amplification strategy that combines eleven HLA genes, in three separate tubes. The product will include new amplification strategies that largely provide whole-gene coverage of the relevant HLA genes. The product is scheduled to be available as CE-marked IVD in Q3 of 2020.

About High-Resolution HLA Typing
The HLA system consists of a large family of highly variable genes and allelic variants which form the basis of the human immunological defense system. In stem cell transplantation, matching patient and donor is vital as small differences between HLA alleles may have serious effects on the outcome of transplantation. High-resolution typing is a technology which enables determination of variations in nucleotides, making it ideal for stem cell transplantation purposes.
GenDx offers the NGSgo® reagent line and the NGSengine software package for NGS-based HLA typing.

Source: GenDx (press release)