Swedish molecular diagnostics company Devyser, announced today at the 45th annual European Bone Marrow Transplantation (EBMT) meeting in Frankfurt, Germany, the release of a new NGS-based assay for ultrasensitive and precise measurement of mixed chimerism after Human Stem Cell Transplantation. At EBMT, Devyser presented data obtained with the new Devyser Chimerism assay generated in collaboration with researchers at the Section for Transplantation Immunology at the Karolinska Hospital in Stockholm, Sweden.
Dan Hauzenberger, Medical director at the Section for Transplantation Immunology at the Karolinska Hospital and founding partner of Devyser says;
"Current technologies for measurement of mixed chimerism either have limitations in sensitivity, or lack precision at higher levels of mixed chimerism. In this study we show that assays utilizing the quantitative properties of the NGS technology may replace both current STR and qPCR protocols used in our lab with a single assay combining both high sensitivity and precision throughout the dynamic range of the test."
Ulf Klangby, CEO of Devyser, says,
"We are very happy to provide routine diagnostics labs with an assay that offers all the advantages of modern technologies in a single test. This solution will relieve laboratories of the burden of labor-intensive and combined complex workflows so that they can really focus on diagnostics."
The Devyser Chimerism kit, including a dedicated software, will immediately be launched worldwide and will initially be available as a research-use assay.
More than 50000 patients undergo HSCT every year, worldwide and HSCT is still the only curative treatment for hematological malignancies. Recurrence of the underlying disease is still the most common cause of treatment failure in these patients with a relapse rate of up to 20% of the patients. Success in treatment intervention during relapse is very much dependent on the availability of early (sensitive) detection and quantification of mixed chimerism and minimal residual disease.
Devyser Chimerism is an NGS library kit which enables both screening and monitoring using a single reaction mix. The kit displays high sensitivity (LOD 0.1%) and accuracy across a wide dynamic range of 0.2-100%. The kit simplifies the laboratory workflow, eliminates the need for patient-specific marker sets and thereby reduces stockholding and reagent wastage. A dedicated analysis software makes screening, monitoring, and reporting fast and cost-efficient.