NEW YORK (GenomeWeb) – GenDx announced today that it has received IVD marking from South Korean regulators for its NGSgo human leukocyte antigen (HLA) typing workflow used in transplant medicine.
According to the company, the workflow is now cleared by the South Korean Ministry of Food and Drug Safety for the typing of HLA-A, B, C, DRB1, and DQB1 by next-generation sequencing on Illumina Miseq platforms, followed by analysis with GenDx's NGSengine software.
HLA genes code for cell-surface antigen-presenting proteins, and HLA typing is an important genetic analysis in assessing compatibility between donor and recipient in stem cell and solid organ transplants since mismatches can result in transplant failure.
"It took a great deal of work to complete the registration, and we are proud to be the first supplier that can offer IVD NGS products for HLA typing in South Korea," GenDx CEO Wietse Mulder said in a statement.
Last week, GenDx received CE-IVD marking for its its line of PCR-based chimerism monitoring products for use in stem cell or bone marrow transplantation.