MedPath

Devyser and Thermo Fisher Collaborate to Secure FDA Approval for Kidney Transplant Monitoring Test

• Devyser and Thermo Fisher Scientific are partnering to gain FDA approval for One Lambda Devyser Accept cfDNA, an NGS test for kidney transplant monitoring. • The test detects donor-derived cell-free DNA (ddcfDNA) in kidney transplant patients' blood samples, aiding in post-transplant monitoring. • Once approved, it will be Devyser's first FDA-approved post-transplant monitoring product, potentially transforming kidney transplant monitoring in the U.S. • Thermo Fisher Scientific is the exclusive global distributor of Devyser's transplantation products, including One Lambda Devyser Accept cfDNA.

Devyser and Thermo Fisher Scientific 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) in blood samples from kidney-transplanted patients.

Aiming to Transform Kidney Transplant Monitoring

According to Devyser CEO Fredrik Alpsten, securing FDA approval for One Lambda Devyser Accept cfDNA has the potential to change how kidney transplant 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's expertise in working with regulators is expected to streamline the approval process for Devyser's post-transplant product.

Partnership Synergies

Thermo Fisher Scientific currently serves as the exclusive global distributor for Devyser’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, expressed enthusiasm about furthering the collaboration with Devyser. 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.

Product Status and Availability

One Lambda Devyser Accept cfDNA 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.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

NextBioMedical's Nexsphere-F Receives FDA IDE Approval for Knee Osteoarthritis Trial

NextBioMedical's Nexsphere-F has received FDA IDE approval for a clinical trial (RESORB) to treat knee osteoarthritis via genicular artery embolization (GAE).
The RESORB trial is a multi-center, randomized, open-label study evaluating Nexsphere-F's efficacy in alleviating pain and improving mobility in OA patients.

SQ Innovation's Lasix ONYU Receives Tentative FDA Approval for Congestive Heart Failure Treatment

SQ Innovation's Lasix ONYU, a combination of furosemide and an on-body device, receives tentative FDA approval for treating fluid overload in congestive heart failure.
The device, developed with Gerresheimer, allows precise, controlled drug administration and is designed for patient comfort and environmental sustainability.

uniQure Receives FDA Nod for Accelerated Approval Pathway for Huntington's Disease Gene Therapy

uniQure secured FDA agreement to pursue accelerated approval for its Huntington's disease gene therapy, potentially expediting treatment availability.
The FDA's decision reflects a more flexible approach to genetic medicines for severe rare diseases under Peter Marks.

Datopotamab Deruxtecan BLA Submitted to FDA for EGFR-Mutated NSCLC

AstraZeneca and Daiichi Sankyo submitted a BLA to the FDA for datopotamab deruxtecan (Dato-DXd) to treat adults with metastatic or locally advanced EGFR-mutated NSCLC who have received prior treatment.
The BLA submission is based on data from the phase 2 TROPION-Lung05 study and pooled analysis from TROPION-Lung01, demonstrating enhanced efficacy in EGFR-mutant NSCLC.

Intelligent Bio Solutions Advances Fingerprint Drug Screening Tech Towards FDA Approval

Intelligent Bio Solutions reports positive pharmacokinetic study results, indicating fingerprint sweat accurately reflects codeine levels in blood and saliva.
The company plans to submit the PK study data as part of its 510(k) submission to the FDA by the end of the year.

Envoy Medical's Acclaim Cochlear Implant Receives FDA Approval for Pivotal Clinical Study

Envoy Medical's Acclaim Cochlear Implant receives FDA approval for its Investigational Device Exemption (IDE) application, marking a significant step in its development.
The Acclaim device uses an implanted sensor to capture sound, differing from existing cochlear implants and potentially offering a more discrete option.

FDA Grants Priority Review to Telix's Pixclara for Glioma Imaging

The FDA has accepted Telix Pharmaceuticals' New Drug Application for TLX101-CDx (Pixclara), a PET imaging agent for glioma, granting priority review.
Pixclara targets LAT1 and LAT2, offering potential as a companion diagnostic for Telix's TLX101-Tx, currently in development for glioblastoma.

FDA Grants Priority Review to Vimseltinib for Tenosynovial Giant Cell Tumor

The FDA has granted priority review to vimseltinib for treating tenosynovial giant cell tumor (TGCT), setting a PDUFA goal date of February 17, 2025.
Vimseltinib, a CSF1R inhibitor, demonstrated a 40% overall response rate in the MOTION phase 3 trial, significantly higher than placebo (0%).

FDA Grants SeaStar Medical's Selective Cytopheretic Device Breakthrough Device Designation for Hepatorenal Syndrome

SeaStar Medical Holding Corporation has received its third Breakthrough Device Designation from the FDA for its Selective Cytopheretic Device (SCD), aimed at treating patients with acute kidney injury and acute on chronic liver failure in the ICU. This designation is expected to accelerate the clinical development and regulatory review of the SCD for hepatorenal syndrome, a condition with a high mortality rate. Positive outcomes from a pilot study at the University of Michigan suggest the SCD's potential in improving patient outcomes as a bridge to liver transplantation.

FDA Draft Guidance Supports Use of ctDNA in Early-Stage Solid Tumor Drug Development

The FDA issued draft guidance on using circulating tumor DNA (ctDNA) as a biomarker in early-stage solid tumor clinical trials and in vitro diagnostic assays.
ctDNA, derived from tumors, is used in liquid biopsies to detect tumors, monitor progression, and detect minimal residual disease (MRD), aiding in cancer relapse prediction.

Reference News

[1]
Devyser seeks to secure FDA approval for NGS test for kidney transplant monitoring
placera.se · Oct 29, 2024

Devyser and Thermo Fisher Scientific collaborate to seek FDA approval for One Lambda™ Devyser Accept cfDNA, a NGS soluti...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy