Devyser today announced that One Lambda™ Devyser Accept cfDNA, its test for monitoring kidney transplant patients, can now also be used after heart and lung transplantation. The new applications are IVDR-compliant, meaning they meet the EU regulation for in vitro diagnostic tests. Through the established collaboration with Thermo Fisher Scientific, laboratories can now monitor kidney, heart and lung transplant recipients with one non-invasive, blood-based solution. Each year, around 2,900 heart and 2,500 lung transplants are performed in Europe, according to the Council of Europe's 2025 transplant data.
“This is an important step in our collaboration with Thermo Fisher Scientific. Laboratories want one solution that works across organ types, and with heart and lung added to kidney, they now have it,” said Jan Wahlström, CEO of Devyser. “It opens up a larger group of patients for our test, and Thermo Fisher Scientific’s global reach helps us get it to the laboratories that need it.”
One Lambda Devyser Accept cfDNA is a next-generation sequencing (NGS)-based solution for detecting and quantifying donor-derived cell-free DNA (dd-cfDNA), a marker that can signal damage to a transplanted organ. Changes in dd-cfDNA may provide an earlier indication of graft injury than conventional monitoring alone, supporting timely clinical assessment and potentially reducing the need for invasive biopsies. The expanded solution combines a sensitive assay with updated Advyser Solid Organs software, enabling laboratories to streamline workflows, reduce hands-on time and perform testing locally.
The solution uses genetic markers that work across patient populations to measure donor-derived cell-free DNA. Results are available within two days, giving laboratories greater control over the testing process. The new applications reach customers through Thermo Fisher Scientific's global commercial network, extending Devyser's reach in the solid-organ transplantation market.
"We are pleased to continue our collaboration with Devyser as we expand the availability of One Lambda Devyser Accept cfDNA," said Tina Liedtky, President of the Transplant Diagnostics business at Thermo Fisher Scientific. "With heart and lung added, laboratories can follow more of their transplant patients on the same workflow. We look forward to making it available to our customers."