Download GenDx Signs Global Reseller Agreement for Thermo Fisher

GenDx Signs Global Reseller Agreement for Thermo Fisher Scientific
Next-Generation Sequencing Instruments
Utrecht, 10th 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 CEIVD mark in 2016. GenDx has already begun the process to obtain CE-IVD marking for the GenDx’s HLANGSgo® 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: [email protected]
Contact
Alina Kosoriga MSc
Marketing & Communication Associate
Email [email protected]
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.