Thermo Fisher Scientific announced a collaborative agreement with Mainz Biomed N.V., through its subsidiary Life Technologies Corporation, to pursue U.S. Food and Drug Administration (FDA) approval for One Lambda™ Devyser Accept cfDNA. This co-branded Next-Generation Sequencing (NGS) solution is designed for detecting donor-derived cell-free DNA (ddcfDNA) in blood samples from kidney-transplanted patients.
This collaboration aims to secure the first FDA-approved Devyser post-transplant monitoring product, potentially changing how kidney transplant monitoring is conducted in the United States. Thermo Fisher Scientific is already the exclusive global distributor of Devyser’s transplantation products, including One Lambda™ Devyser Accept cfDNA and One Lambda™ Devyser Chimerism.
The partnership combines Thermo Fisher’s expertise and experience with regulators to fast-track studies and complete necessary regulatory activities for FDA approval. This strategic move enhances Thermo Fisher’s portfolio in transplant diagnostics and supports its mission to enable customers to improve patient quality of life.
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