Devyser has received IVDR approval for Advyser Solid organs, its software for the post-transplant product One Lambda Devyser Accept cfDNA. This is Devyser's first European approval for post-transplant monitoring software under the new, more comprehensive IVD regulation that came into force in May 2022, and it confirms Devyser software meets the established safety, efficacy, and quality requirements. Advyser Solid organs is an IVD software for monitoring donor-derived cell-free DNA (dd-cfDNA) in patients following kidney transplantation.

The software is intended for use with One Lambda Devyser accept cfDNA, a novel NGS test for detecting dd-cfDNA in blood samples from kidney transplant patients. The assay received IVDR approval in 2023. The product mentioned is CE-IVD marketed but not FDA-cleared.

Availability in each country depends on local regulatory marketing authorization status.