Devyser and Thermo Fisher Collaborate to Secure FDA Approval for Kidney Transplant Monitoring Test
核心洞察
Devyser (搜索) and Thermo Fisher Scientific (搜索) are partnering to gain FDA approval for One Lambda Devyser Accept cfDNA (搜索), an NGS test for kidney transplant (搜索) monitoring.
The test detects donor-derived cell-free DNA (ddcfDNA (搜索)) in kidney transplant (搜索) patients' blood samples, aiding in post-transplant monitoring.
Once approved, it will be Devyser (搜索)'s first FDA-approved post-transplant monitoring product, potentially transforming kidney transplant (搜索) monitoring in the U.S.
Devyser (搜索) and Thermo Fisher Scientific (搜索) have entered into an agreement to collaborate on securing U.S. Food and Drug Administration (FDA) approval for One Lambda™ Devyser Accept cfDNA, a co-branded NGS (Next Generation Sequencing) solution designed for detecting donor-derived cell-free DNA (ddcfDNA (搜索)) in blood samples from kidney-transplanted patients.
Aiming to Transform Kidney Transplant Monitoring
According to Devyser (搜索) CEO Fredrik Alpsten, securing FDA approval for One Lambda Devyser Accept cfDNA (搜索) has the potential to change how kidney transplant (搜索) monitoring is conducted in the United States. The collaboration leverages the strengths of both companies to expedite studies and regulatory activities necessary for FDA approval. Thermo Fisher Scientific (搜索)'s expertise in working with regulators is expected to streamline the approval process for Devyser's post-transplant product.
Partnership Synergies
Thermo Fisher Scientific (搜索) currently serves as the exclusive global distributor for Devyser (搜索)’s transplantation products. This includes One Lambda™ Devyser Accept cfDNA, One Lambda™ Devyser Chimerism (used for screening and follow-up post stem cell transplantation), and associated software solutions.
Tina Liedtky, President of Transplant Diagnostics at Thermo Fisher Scientific (搜索), expressed enthusiasm about furthering the collaboration with Devyser (搜索). The goal is to enable customers to enhance surveillance and improve the quality of life for the over 150,000 Americans living with a kidney transplant (搜索).
Product Status and Availability
One Lambda Devyser Accept cfDNA (搜索) is currently CE-IVDR marked but has not yet received FDA clearance. Its availability is subject to local regulatory marketing authorization status in each country. Healthcare professionals are advised to consult their local sales representatives for specific details.