Devyser Gets Canadian Approval for Stem Cell Transplant Monitoring Test

Original from: genomeweb

Swedish diagnostics firm Devyser said Thursday that its next-generation sequencing-based test for stem cell transplantation monitoring has received regulatory approval in Canada.

The One Lambda Devyser Chimerism test is designed for the quantification of donor and recipient DNA following hematopoietic stem cell transplantation, which enables the detection of graft rejection or disease relapse.

According to Devyser, the test has been granted approval by Health Canada as a Class III In Vitro Diagnostic medical device, along with its companion Advyser Chimerism data analysis software.

Thermo Fisher Scientific holds the exclusive North American and European commercialization rightsto the chimerism test, which received European IVDR certification in mid-2023. Devyser retains the right to offer it to labs in the US via its service laboratory.

Source:  Devyser Gets Canadian Approval for Stem Cell Transplant Monitoring Test