NEW YORK (GenomeWeb) – Dutch genetic testing firm GenDx announced on Wednesday that it has received a medical device license from Canadian regulators for its NGSengine human leukocyte antigen (HLA) typing software.
The software provides analyses of HLA typing by next-generation sequencing on several platforms, including Illumina's MiSeq, Thermo Fisher Scientific's IonTorrent PGM, and Pacific Biosciences' PacBio RSII. It includes whole-gene representation, automatic allele assignment and multi-loci analysis, and simultaneous genotyping of multiple HLA loci, as well as a variety of reviewing and reporting options. The software was CE marked in early 2016.
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.
"Next-generation sequencing is rapidly becoming the new gold standard for high resolution HLA typing due to its ease of use and capability to process large data volumes in short time," GenDx Cofounder and CEO Wietse Mulder said in a statement. "Powerful software is an essential step in determining the HLA alleles of both donor and patient. I am glad that our NGSengine package can fulfill this pivotal role in transplantation diagnostics."