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Devyser Nabs IVDR Certification for Solid Organ Transplant Health Monitoring Software

NEW YORK – Devyser announced Thursday that it received In Vitro Diagnostic Regulation (IVDR) certification in the EU for its Advyser Solid Organs kidney transplant health monitoring software.

The post-transplant software analyzes next-generation sequencing data from the Swedish firm's One Lambda Devyser Accept cfDNA assay for detecting donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients. That assay received IVDR certification last year.

"Achieving IVDR certification for our software demonstrates Devyser's commitment to pioneering genetic testing," Devyser CEO Fredrik Alpsten said in a statement. "This approval is another confirmation of our strong regulatory expertise and testament to the high quality, safety, and compliance of Devyser products. We are confident this approval will further enhance the growth potential of our transplantation products." 

Last month, the company published a study demonstrating the ability of its One Lambda assay to discriminate dd-cfDNA from multiple kidney donors in a single recipient, as part of its push to eventually obtain US regulatory approval.