Devyser has entered an agreement with Thermo Fisher Scientific to collaborate on obtaining U.S. Food and Drug Administration (FDA) approval for One Lambda? Devyser Accept cfDNA, their cobranded NGS solution for detecting donor-derived cell-free DNA (ddcfDNA) in blood samples from kidney-transplanted patients. Once approved, this will be the first FDA-approved Devyser post-transplant monitoring product.

Thermo Fisher is the exclusive distributor of Devyser?s transplantation products globally. This includes One Lambda? Devyser Accept cfDNA and One Lambda?

Devyser Chimerism for screening and follow-up of post stem cell transplantation, along with the corresponding software solutions. One Lambda Devyser Accept cfDNA is CE-IVDR marked but not FDA-cleared. Availability in each country depends on local regulatory marketing authorization status.

Please consult your local sales representative for details.