The Transplant Diagnostics business of Thermo Fisher Scientific and Devyser Diagnostics AB have entered into a collaboration and distribution agreement to commercialize the Devyser post-transplant monitoring portfolio. Under the agreement, Thermo Fisher Scientific gains exclusive rights to market and sell Devyser's post-transplant monitoring assays in the United States, Canada, and Europe.
Nicole Brockway | President, Transplant Diagnostics, Thermo Fisher Scientific
Devyser's post-transplant portfolio, which is pending IVDR certification for the European market, includes Devyser Chimerism NGS for screening and follow-up of post-stem cell transplantation and Devyser Accept cfDNA, a novel test for detection of cell-free DNA (cfDNA) in blood samples from kidney-transplant patients.
Chimerism analysis is used in bone marrow transplant monitoring to assess the success of engraftment, detect graft rejection or disease relapse, guide treatment decisions, and provide long-term follow-up in transplanted patients.
cfDNA is an important biomarker for evaluating kidney graft health post-transplantation. Kidney transplantation is a preferred option for patients with end-stage renal disease (ESRD), affecting millions of people globally, as it provides higher patient survival and superior quality of life compared to dialysis.
The partnership between Devyser and Thermo Fisher Scientific provides a strong proposition to HLA labs and transplant clinicians and is backed by the commercial infrastructure and resources of Thermo Fisher Scientific.
Article published: 2023 April 24
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