GenDx has registered NGSgo®-MX11-3 as CE-marked IVD
The product can now be used for accurate HLA typing of donors and patients in need of organ or stem cell transplantation. The approval of NGSgo-MX11-3 completes the series of our CE-marked IVD amplification products, including a singleplex (NGSgo®-AmpX v2) and a six-gene multiplex (NGSgo®-MX6-1) strategy for HLA typing by Next-Generation Sequencing (NGS). All amplification products can be used in combination with the recently CE-marked IVD Library Full Kit for indexing, library preparation, and cleanup.
NGSgo-MX11-3 consists of amplification primers for eleven HLA genes (HLA-A, -B, -C, -DRB1, -DQB1 and -DPB1, DRB3/4/5, DQA1, and DPA1). The three-tube design results in low noise levels and well-balanced alleles, providing similar high-quality data with the 11-loci multiplex compared to the singleplex strategy.
Dr. Wietse Mulder, CEO of GenDx, commented: “We are proud to now offer the NGSgo-MX11-3 multiplex amplification for diagnostic use, and we are convinced this innovative product will accelerate the demand for high-quality multiplex data for stem cell transplantation”
Read the complete press release here