Devyser seeks to secure FDA approval for NGS test for kidney transplant monitoring
October 29, 2024 at 04:30 am EDT
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Devyser has entered an agreement with Thermo Fisher Scientific to collaborate on obtaining U.S. Food and Drug Administration (FDA) approval for One Lambda™ Devyser Accept cfDNA, their cobranded NGS solution for detecting donor-derived cell-free DNA (ddcfDNA) in blood samples from kidney-transplanted patients. Once approved, this will be the first FDA-approved Devyser post-transplant monitoring product.
“Securing FDA-approval for One Lambda Devyser Accept cfDNA has the potential to change how kidney transplant monitoring is done in the United States. The collaboration with Thermo Fisher Scientific, the world leader in serving science, is a great opportunity for us to combine the strengths of both companies to fast-track studies and complete the necessary regulatory activities to obtain FDA approval in the shortest time possible. With Thermo Fisher’s expertise and experience working with regulators, we are confident that this collaboration will secure the most efficient pathway for FDA-approval of our post-transplant product in the U.S.,” says Fredrik Alpsten, Devyser CEO.
Thermo Fisher is the exclusive distributor of Devyser’s transplantation products globally. This includes One Lambda™ Devyser Accept cfDNA and One Lambda™ Devyser Chimerism for screening and follow-up of post stem cell transplantation, along with the corresponding software solutions.
“We are pleased to further our collaboration with Devyser, with the ultimate aim of enabling our customers to enhance surveillance and improve quality of life for the more than 150,000 Americans living with a kidney transplant," says Tina Liedtky, President, Transplant Diagnostics, Thermo Fisher Scientific.
One Lambda Devyser Accept cfDNA is CE-IVDR marked but not FDA-cleared. Availability in each country depends on local regulatory marketing authorization status. Please consult your local sales representative for details.
Thermo Fisher Scientific Inc. specializes in the design, manufacturing and marketing of laboratory and scientific equipments. Net sales (including intragroup) break down by family of products as follows:
- laboratory equipments (70%). Moreover, the group proposes chemical products (reagents, solvent, salts, etc.), consumable products (tubes, funnels, vials, etc.), as well as conditioning, warehousing, storage, etc.;
- diagnostics equipment and products (15.3%);
- scientific analysis equipments (14.7%): analyzer (of water, gas, grounds, etc.), mass spectrometers, molecular spectroscopes, microscopes, manometers, samplers, microbiology equipments, reactive agents, etc.
Net sales break down by source of income into products sales (78.5%) and services (21.5%).
Net sales break down geographically as follows: North America (53%), Europe (25.7%), Asia-Pacific (18.1%) and others (3.2%).
THERMO FISHER SCIENTIFIC INC. 
