23d August, 2017
Health Canada has granted GenDx a Medical Device License (MDL) for NGSengine®.
NGSengine analyses Next Generation Sequencing (NGS) data and identifies all classical and non-classical HLA genes at allelic level. This software package can even run on a regular desktop.
NGSengine is validated with data derived from a diverse set of NGS equipment, such as Illumina Miseq®, Ion Torrent PGM® and S5® and PacBio RSII® sequencer.
The software is released in accordance with the IEC62304, the international harmonized standard by the European Union and the United States. This standard is applicable to medical device software, specifying life cycle requirements for medical software and software within medical devices.
NGSengine is registered as a CE-marked IVD since 2016, and now HLA typing laboratories in Canada can also use this software package for diagnostic purposes.
Wietse Mulder, co-founder and CEO of GenDx commented: “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. 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. Our customers worldwide consider NGSengine as the best software solution available. We are glad that the software package now is also available as an IVD registered solution in Canada.”