Devyser aims to secure FDA approval for monitoring product
The company has entered into a collaboration agreement with Thermo Fischer Scientific to obtain regulatory approval from the FDA for One Lambda Devyser Accept cfDNA. This is an NGS solution for the detection of cell-free donor DNA in blood samples from patients undergoing kidney transplantation. If approved, it will be Devyser's first FDA-cleared product for post-transplant monitoring.
"Obtaining FDA approval for One Lambda Devyser Accept cfDNA has the potential to change the way post-transplant monitoring is performed in the United States. The collaboration with Thermo Fisher Scientific, a world leader in science services, is a great opportunity for us to combine the strengths of both companies to accelerate studies and complete the necessary regulatory activities to obtain FDA clearance in the shortest possible time," said CEO Fredrik Alpsten.
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