10 april 2017

GenDx has signed a global reseller agreement with Thermo Fisher Scientific for the rights to offer an end to end workflow to HLA typing laboratories that includes the Ion Torrent brand of next-generation sequencing (NGS) systems and consumables with GenDx assays and analysis software for allelic level HLA typing analyses.

Under the agreement, GenDx and its distributors is authorized to provide the Ion PGM, Ion S5 and Ion Chef systems with GenDx’s HLA-NGSgo® reagents and NGSengine® software within the field of HLA sequencing.

Wietse Mulder, co-founder and CEO of GenDx commented: “We are very pleased to have signed this global agreement and we are really enthusiastic about expanding the collaboration with our trusted OEM partner, Thermo Fisher Scientific. We are glad to offer researchers, active in the field of transplantation diagnostics, alternatives to obtain high-resolution HLA typing by NGS. We have evaluated the HLA typing results with the NGSgo® full workflow strategies on multiple NGS platforms. The Ion PGM and Ion S5 systems provide reliable typing results that are of high resolution and phasing comparable to other NGS platforms on the market. This expanded relationship reinforces our leading position in the field of HLA typing. It also fits to our company’s mission, to be an independent organisation with respect to our business partners. At GenDx, our efforts are focused on offering molecular diagnostics solutions that combine scientific innovation with reliability, ultimately leading to a better outcome of transplantation.”

Readers of this message, who are interested in HLA typing by NGS and wonder whether they could benefit from this new agreement, can receive more information by contacting their local GenDx distributor or contacting GenDx directly.

About High Resolution HLA Typing
The Human Leukocyte Antigen (HLA) system consists of a large family of highly variable genes and allelic variants, which form the basis of the human immunological defence system. I High resolution typing is a technology, which enables determination of even the smallest of variations in nucleotides, making it ideal for stem cell transplantation research. Until today, Sanger sequencing based HLA typing is considered the golden standard for high resolution typing. GenDx offers SBTexcellerator® and AlleleSEQR® together with the software package SBTengine® for carrying out Sanger sequencing typing.

In 2013, GenDx started, as one of the pioneer companies in the HLA field, offering NGS strategy, including NGSgo® reagents together with the software package NGSengine®. These products are available for workflows to be used on various NGS platforms. Both Sanger and NGS techniques analyse the actual DNA sequence of the relevant HLA region. Moreover, identifying and characterizing new HLA alleles with these techniques is crucial as well.

Since 2014, NGSgo®-AmpX is CE-IVD and the NGSgo® full workflow for Illumina MiSeq received the CE-IVD mark in 2016. GenDx has already begun the process to obtain CE-IVD marking for the GenDx’s HLA-NGSgo® reagents and NGSengine® software within the field of HLA sequencing utilizing the Ion Torrent instruments.

NGS is supposed to become the new golden standard for HLA typing, as data analysis using NGS is becoming easier and faster to interpret and this technique is suitable for higher throughput. NGSengine software has been tested and released in accordance with the IEC62304, the international harmonized standard by the European Union and the United States. This standard is applicable for medical device software, specifying life cycle requirements for medical software and software within medical devices.

About GenDx
Genome Diagnostics B.V., 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 reagents and software for both Sanger and NGS based approaches. In 2013, GenDx started selling products for post-transplant or chimerism monitoring based on real time PCR. Thanks to its extensive in-house expertise, GenDx also offers 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. The global sales of the products is supported by the GenDx team in Utrecht, local distributors or through subsidiaries; GenDx Products, Utrecht (Benelux, Canada and ROW when no local distributor present) and the USA GenDx Prod Inc. team based at UMBC in Baltimore MD, USA.

GenDx is also authorized to resell Illumina NGS instruments and cartridges for a limited number of countries in Europe.

GenDx Netherlands
Yalelaan 48
3584 CM Utrecht
Office: +31 30 252 3799
E-mail: info@gendx.com

Contact
Alina Kosoriga MSc
Marketing & Communication Associate
Email a.kosoriga@gendx.com
Phone: +31 30 252 3799

SBTexcellerator®, NGSgo®, AlleleSEQR®, SBTengine® and NGSengine® are registered trademarks of GenDx. GenDx is a registered trade name of Genome Diagnostics B.V. PGM®, S5®, and IonChef® are trademarks of Thermo Fisher. MiSeq® is a trade mark of Illumina.

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