Health Canada grants IVD approval to Devyser’s NGS-based chimerism test, the first of its kind in Canada
Health Canada has approved Devyser's NGS-based chimerism test as Class III IVD medical devices, marking the first such approval in Canada. This sets a new standard for post-transplant monitoring, enabling accurate DNA quantification post-HSCT. The approval reflects Devyser's commitment to high-quality molecular diagnostics, benefiting Canadian labs with streamlined processes and rapid turnaround.
Devyser is proud to announce that One Lambda Devyser Chimerism and Advyser Chimerism have been granted approval as Class III In Vitro Diagnostic (IVD) medical devices by Health Canada. With this we set a new standard for post-transplant monitoring nationwide as this is the first ever IVD-marked chimerism test to receive approval in Canada.
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.
