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GenDx Gets CE-IVD Mark for 11-Gene HLA Typing Product

NEW YORK — Genome Diagnostics said on Thursday that it has received CE-IVD marking for its NGSgo-MX11-3 human leukocyte antigen typing product for organ and stem cell transplantation testing.

According to the Dutch company, the NGSgo-MX11-3 uses a multiplex amplification strategy that combines primers for eleven HLA genes — HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, and DPA1 — in three tubes for next-generation sequencing-based HLA typing.

The product provides whole-gene coverage, resulting in low-ambiguity genotyping and resolution of nearly all null alleles, GenDx said.

GenDx said it is conducting studies to validate the compatibility of NGSgo-MX11-3 with the main NGS platforms including ones from Illumina, Thermo Fisher Scientific's IonTorrent, and Pacific Biosciences.

In early 2020, GenDx received the CE mark for its six-gene NGSgo-MX6-1 and single-plex NGSgo-AmpX v2 HLA typing products.

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