One Lambda™ Devyser novel tests for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplanted patients fulfill IVDR requirements in Europe. These tests are the first post-transplant monitoring NGS products to be approved under the new, more comprehensive regulation that came into force in May 2022 and confirm these two NGS products meet the established safety, efficacy, and quality requirements.
Thermo Fisher Scientific™, Devyser’s commercialization partner for these products, can now market and sell the regulatory-approved products in all European markets.
Fredrik Alpsten | CEO at Devyser
The IVDR approved products are One Lambda Devyser Chimerism, for early detection of mixed chimerism in stem cell transplant patients, and One Lambda Devyser Accept cfDNA, a novel test for the detection of donor-derived cell-free DNA in blood samples from kidney transplant patients.
From May 26, 2022, all new medical devices to be sold in Europe must comply with the new IVD Regulation (IVDR) to ensure the highest level of public health protection.
The partnership between Devyser and Thermo Fisher Scientific provides a strong proposition to HLA labs and transplant clinicians and is backed by the commercial infrastructure and resources of Thermo Fisher Scientific. Under the agreement, Thermo Fisher Scientific gains exclusive rights to market and sell Devyser's post-transplant monitoring assays in the United States, Canada, and Europe.
Article published: 2023 July 17
Products are CE marked but not 510(k)-cleared and not available for sale in the U.S. Availability of product in each country depends on local regulatory marketing authorization status.