GenDx is the first global company to register a chimerism monitoring product line as CE-IVD. The chimerism portfolio is intended for monitoring the chimeric status after stem cell or bone marrow transplantation, and includes KMRtype® and KMRtrack® reagents, as well as KMRengine® software.

The in vitro diagnostic products will be distributed to clinical laboratories, supporting transplant centers worldwide to accurately monitor the chimeric status of transplant recipients. The products are based on real-time PCR, which makes them 10-50 fold more sensitive than the widely used short tandem repeats (STR) detection strategy. Therefore, relapses can be detected significantly earlier compared to the STR method, which enables earlier treatment decisions.

Using the KMRtype® reagent, informative genetic markers are selected for donor-recipient pairs. Subsequently, the KMRtrack reagent is used to monitor the markers over time. The KMRengine software guides the laboratory workflow and analyzes the data. The workflow can be performed on a wide range of real-time PCR platforms and has been extensively validated on several Thermo Fisher systems, such as ABI7500 and QuantStudio systems. Recently, GenDx has signed a global reseller agreement with Thermo Fisher Scientific assigning GenDx as a nonexclusive reseller of Applied Biosystems™ QuantStudio™ real-time PCR systems, including the QuantStudio 5, QuantStudio 6 Flex, and QuantStudio 7 Flex.

The software KMRengine® has been developed 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.

Dr. Wietse Mulder, CEO of GenDx, commented: “We have worked really hard to improve and validate our real-time PCR reagents and software package and are thrilled that we have realized the design goals and the CE-IVD registration. This set of diagnostic tools advances accurate chimerism monitoring of transplant patients, and supports timely intervention when needed. This accomplishment strengthens our pioneer status in the field of transplantation diagnostics and establishes GenDx as the global leader of chimerism monitoring solutions using real-time PCR.”

About Chimerism Monitoring

After stem cell or bone marrow transplantation, both donor and recipient cells can be detected in the recipient’s blood (chimeric status). Monitoring the chimeric status allows for the detection of recipient cells returning over time, which can possibly lead to a relapse state. The real-time PCR technology provides high sensitivity, for as little as 0.05% of returning recipient cells can be accurately detected. This leads to a better prediction of relapse, and can subsequently lead to timely intervention. The realtime PCR technology is superior to short tandem repeat (STR) technology, which has limited sensitivity and is used for relapse confirmation rather than prediction. GenDx has been offering KMRtype/KMRtrack reagents since 2013 for research purposes. Currently, the complete set contains 39 assays that allow for the detection of 39 unique markers based on bi-allelic insertions/deletions and SNPs. Software package KMRengine generates a laboratory protocol, qPCR machine sample setup sheet, and data tracking for each recipient/donor couple over time.

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 is specialized in HLA sequencing-based typing strategies and offers reagents and software for both Sanger and NGS approaches. In 2013, GenDx started developing and distributing products for chimerism monitoring by qPCR. Thanks to its extensive in-house expertise, GenDx also offers custom laboratory services for basic and clinical research organizations. GenDx organizes dedicated HLA SBT and chimerism monitoring training courses worldwide on a regular basis for lab directors, lab managers, scientists and technicians working in tissue typing laboratories, blood banks and donor registries.

GenDx is based at the University Science Park in Utrecht, 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. Further information about GenDx can be found at www.GenDx.com. Global sales is supported by the GenDx team in Utrecht, local distributors, or subsidiaries: GenDx Products based in Utrecht (Benelux, Canada and ROW when no local distributor present) and GenDx Products Inc. based at UBMC in Baltimore, MD (USA).