Skip to main content
Premium Trial:

Request an Annual Quote

GenDx CE-IVD Registers Chimerism Monitoring Product Line

NEW YORK (GenomeWeb) – Dutch genetic testing firm Genome Diagnostics (GenDx) announced on Tuesday that it has CE-IVD registered its line of chimerism monitoring products for use in stem cell or bone marrow transplantation.

The in vitro diagnostic products include the company's KMRtype and KMRtrack reagents and its KMRengine workflow-management and data-analysis software. The KMRtype reagent is used to select informative genetic markers for donor-recipient pairs, the KMRtrack reagent is subsequently used to monitor the markers over time, and the KMRengine software guides the workflow in the lab and analyzes the data, the company said.

GenDx noted that the workflow can be performed on several real-time PCR platforms and has been validated on Thermo Fisher Scientific's ABI7500 and QuantStudio systems. The firm also recently signed an agreement to become a global reseller for Thermo Fisher's Applied Biosystems QuantStudio PCR systems, including the QuantStudio 5, QuantStudio 6 Flex, and QuantStudio 7 Flex.

"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," GenDx CEO Wietse Mulder said in a statement. "This set of diagnostic tools advances accurate chimerism monitoring of transplant patients and supports timely intervention when needed."

In early 2016, GenDx received CE-IVD certification for its NGSengine software for analyzing human leukocyte antigen typing in transplant recipients via next-generation sequencing.

The Scan

Polygenic Risk Score to Predict Preeclampsia, Gestational Hypertension in Pregnant Women

Researchers in Nature Medicine provide new mechanistic insights into the development of hypertensive disorders of pregnancy, which may help develop therapeutics.

New Oral Nanomedicine Strategy Targets Gut-Brain Axis to Treat IBD

A new paper in Science Advances describes a platform to design polyphenol-armored oral medicines that are effective at treating inflammatory bowel disease.

Phylogenetic Data Enables New Floristic Map

Researchers in Nature Communications use angiosperm phylogenetic data to refine the floristic regions of the world.

Machine Learning Helps ID Molecular Mechanisms of Pancreatic Islet Beta Cell Subtypes in Type 2 Diabetes

The approach helps overcome limitations of previous studies that had investigated the molecular mechanisms of pancreatic islet beta cells, the authors write in their Nature Genetics paper.