Utrecht, the Netherlands

GenDx has completed IVD registration in Canada for two NGSgo products.
1) NGSgo®-AmpX v2 for individual HLA gene amplification
2) NGSgo®-MX6-1 for multiplexed amplification of six HLA genes in one tube
The amplification products can be used to obtain high-resolution HLA genotyping information by
means of downstream sequencing applications, and genotype analysis with IVD-registered NGSengine® software.
The completion of the registration makes NGSgo the first IVD product line in Canada that is suitable
for diagnostic NGS-based HLA typing of donors and patients in need of a stem cell transplantation.

NGSgo-AmpX v2 is the successor of the original NGSgo-AmpX, which is successfully being sold
globally. This v2 product uses the same primer design, but has been optimized by a faster cycling
protocol, colored primers for easier handling, and a convenient enzyme mastermix that requires
fewer pipetting steps.
NGSgo-MX6-1 is a more recently released multiplex amplification strategy, that combines
amplification primers of six HLA genes (HLA-A, B, C, DRB1, DQB1 and DPB1) in a single tube. The
primer design is similar to the robust NGSgo-AmpX approach, resulting in a product that delivers high
quality data, while the number of pipetting steps and hands-on time are greatly reduced.

Wietse Mulder PhD, CEO of GenDx, commented: “We have worked intensely to validate and
document these NGSgo products according to the Health Canada IVD regulation. It took a great deal
of work to complete, and we are proud to be the first supplier that can offer this IVD product for the
transplant community in Canada. We believe the products will truly support better typing of the HLA
genes.”

About High-Resolution HLA Typing
The Human Leukocyte Antigen (HLA) system consists of a large family of highly variable genes and
many allelic variants which form the basis of the human immunological defense system. In stem cell
transplantations, HLA matching of patient and donor is vital as small differences between HLA alleles
may have serious effects on transplantation outcome. High-resolution genotyping is a technology
which enables determination of even the smallest variations in HLA genes, making it ideal for stem
cell transplantation purposes.
Until recently, Sanger sequencing-based HLA typing was considered the gold standard for highresolution typing. Nowadays, Next Generation Sequencing (NGS) is being adapted by the vast
majority of HLA laboratories worldwide to become the new gold standard for HLA typing. This NGS
approach offers higher resolution and is more suitable for high throughput.
As one of the pioneering companies in the HLA field, GenDx started offering NGS strategies already in
2013, consisting of NGSgo reagents and the software package NGSengine for various NGS platforms.
NGSgo-AmpX was CE marked in 2014, and the NGSgo full workflow compatible with Illumina MiSeq
received the CE mark in 2016. Since 2017, NGSengine is also registered as IVD at Health Canada.

About GenDx
Genome Diagnostics B.V., also known as GenDx, is a Dutch company, specialized in molecular
diagnostics, focused on development, production and sales of innovative assays and analysis
software for transplantation and companion diagnostics. GenDx also has a USA-based office near
O’Hare airport, Chicago, IL.
GenDx specializes in HLA sequencing-based typing strategies and offers reagents and software for
both Sanger and NGS approaches. Additionally, GenDx offers products for chimerism monitoring by
qPCR and is developing products for chimerism monitoring by NGS. Thanks to its extensive in-house
expertise, GenDx also offers custom laboratory services for basic and clinical research organizations.
GenDx Education organizes dedicated HLA sequence based typing and chimerism monitoring training
courses worldwide on a regular basis for anyone working in tissue typing or research laboratories,
blood banks, and donor registries.
GenDx is based at the Utrecht Science Park, the Netherlands and was founded in 2005 by Erik
Rozemuller PhD, Wietse Mulder PhD and UMC Utrecht Holdings B.V. represented by Oscar
Schoots PhD and Raoul Linschoten LLM. In 2019, Ampersand Capital Partners completed a
minority growth equity investment in the company and David Parker joined the GenDx Board of
directors. For further information about GenDx visit www.GenDx.com.

NGSgo® and NGSengine® are registered trademarks of GenDx. GenDx is a registered trade name of Genome Diagnostics B.V. MiSeq® is a registered trademark of Illumina