The approval underscores Devyser’s dedication to providing laboratories and clinicians with high-precision, user-friendly solutions for post-transplant monitoring. One Lambda Devyser Chimerism enables highly accurate quantification of donor and recipient DNA following hematopoietic stem cell transplantation (HSCT) allowing clinicians to detect graft rejection or disease relapse at an early stage. Advyser Chimerism is our data analysis software that complements the assay by streamlining interpretation, reporting, and data management. 

"Achieving Class III IVD approval in Canada and being the first chimerism assay to do so, is a true reflection of teamwork,” said Jan Wahlström, CEO, Devyser. “This also reflects Devyser’s commitment to supporting laboratories, clinicians, and patients through reliable, high-quality molecular diagnostic solutions." 

With this approval, Canadian laboratories can now implement Devyser’s complete chimerism workflow, benefiting from a simplified process, rapid turnaround, and enhanced confidence in post-transplant monitoring. 

One Lambda Devyser Chimerism and Advyser Chimerism are currently available under an exclusive collaboration and distribution agreement between Devyser and Thermo Fisher Scientific.