GenDx has obtained CE marking for the entire AlleleSEQR® product line for HLA sequencing based typing. The products are added to the growing list of CE-marked products like SBTexcellerator®, NGSgo® and SBTengine®, already applied for years. The CE marking will enable HLA typing laboratories to continue to comply with the guidelines for the use of CE-IVD marked AlleleSEQR® products. It also enforces the quality of the GenDx product portfolio to further increase its support to academic institutes and laboratories involved in solid organ or stem cell transplantations.
The CE-marking is the final step of the transition of the AlleleSEQR product line from Quest Diagnostics subsidiary, Celera Genomics to GenDx. As of 1 January 2016 GenDx is fully responsible for manufacturing, distribution and global technical support for all AlleleSEQR products.
The AlleleSEQR products for HLA typing by Sanger sequencing consist of reagents for HLA-A, -B, -C, -DRB1, -DQB1 and DPB1. The HLA-A, -B and -DRB1 product validation files were reviewed by the notified body DEKRA., also authorising the CE-IVD marking of these products. Together with the GenDx self-certified CE-marked kits for HLA-C, -DPB1 and -DQB1, the complete range of AlleleSEQR products is now available as CE-marked IVDs for in vitro diagnostics. Optimal results are obtained when combined with the CE-marked SBTengine® software for high resolution analysis of HLA sequencing data.
An important part of CE-marking process was to demonstrate that AlleleSEQR products manufactured by GenDx have equivalent performance as the products previously manufactured by Celera. On request, the validation report is available for end-users. For Health Canada, the Medical Devices Licensing for AlleleSEQR (MDL 73368) was already transferred to GenDx per September 2015.
About High Resolution HLA Typing
The Human Leukocyte Antigen (HLA) system consists of a large family of highly variable genes and allelic variants which forms the basis of the human immunological defence system. In stem cell transplantation, matching of the patient and donor is vital as small differences between HLA alleles may have serious effects on the outcome of transplantation. High resolution typing is a technology which enables determination of even the smallest of variations in nucleotides, making it ideal for stem cell transplantation purposes. Until today, Sanger sequencing based HLA typing is considered as the gold standard for high resolution typing, although rapidly followed by Next Generation Sequencing (NGS). For this latter strategy GenDx has NGSgo® reagents available for workflows to be used on various NGS platforms. Both Sanger and NGS techniques analyse the actual DNA sequence of the relevant HLA regions of both patient and donor. Furthermore, identifying and characterizing new alleles with these techniques is of great importance as well. NGS is supposed to become the new gold standard for HLA typing as data analyses using NGS is becoming easier and faster to interpret and this technique is also suitable for higher throughput.
About AlleleSEQR HLA typing products
AlleleSEQR HLA kits are dedicated to high resolution HLA Sequencing Based Typing (SBT). The products were previously manufactured by Celera Genomics and until 31 December 2015 globally distributed by
Abbott Molecular. In May 2015, GenDx has finalized the agreement on the purchase of the AlleleSEQR asset for both Sequencing Based Typing as well as for chimerism monitoring. GenDx has the right to distribute globally since 1st October 2015.
The AlleleSEQR kit is used for PCR amplification of the appropriate HLA locus and subsequently DNA sequencing. There are kits for respectively HLA-A, -B, -C, -DRB1, -DQB1 and DPB1. The AlleleSEQR package does include all subcomponents, including AmpliTaq Gold® DNA polymerase (Roche Diagnostics Inc), ExoSAP-IT (Affymetrix Inc.) and BigDye® Terminator (Life Technologies Cooperation). For these subcomponents, GenDx has made separate agreements with the respective suppliers. AlleleSEQR can be used for donor registry typing and has CE-IVD status for transplantation diagnostics.
Genome Diagnostics BV, also known as GenDx is a Dutch company in Molecular Diagnostics, focused on development, production and sales of innovative assays and analysis software for transplantation medicine and companion diagnostics. GenDx is specialized in HLA sequencing based typing strategies and offers reagent and software for both Sanger and NGS based approaches. In 2013, GenDx started together with KimerDx B.V. the offering of products for chimerism monitoring. Thanks to its in-house extensive knowledge, GenDx offers also custom laboratory services for basic and clinical research organisations. GenDx organises dedicated HLA-SBT training courses worldwide on a regular basis for lab directors, lab managers, scientists and technicians working at tissue typing laboratories, blood banks and donor registries. GenDx is a spin-off of the University Medical Centre in Utrecht, the Netherlands and was founded in 2005 by Erik Rozemuller PhD, Wietse Mulder PhD and Oscar Schoots PhD, representing the University Medical Centre Utrecht participaties B.V.. Further information on GenDx can be found at www.gendx.com.
Wietse Mulder PhD
Phone: +31 30 252 3799
SBTexcellerator®, NGSgo®, AlleleSEQR® and SBTengine® are registered trademarks of GenDx.
ExoSAP-IT is a registered trademark of Affymetrix Inc.
BigDye® Terminator® is a registered trademark of Life Technologies Cooperation, a subsidiary of Thermo Fisher Scientific
AmpliTaq Gold® DNA polymerase is a registered trademark of Roche Diagnostics Inc.
GenDx is a registered trade name of Genome Diagnostics B.V.