Tuesday, July 18, 2023
Devyser, a leading company in Next-Generation Sequencing (NGS) solutions, has announced that its novel tests for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and screening and follow-up of stem cell transplanted patients have successfully fulfilled the requirements of the In Vitro Diagnostic Regulation (IVDR) in Europe. These NGS products are the first post-transplant monitoring solutions to be approved under the new and comprehensive regulation that took effect in May 2022, affirming their compliance with established safety, efficacy, and quality standards.
Thermo Fisher Scientific, Devyser's commercialization partner for these products, is now authorized to market and distribute the regulatory-approved products across all European markets as part of their launch plans.
The IVDR approved products include One Lambda Devyser Chimerism, designed for early detection of mixed chimerism in stem cell transplanted patients, and One Lambda Devyser Accept cfDNA, a novel test to detect donor-derived cell-free DNA in blood samples from kidney transplant patients.
Fredrik Alpsten, CEO of Devyser, expressed excitement about the regulatory approvals, highlighting the extensive development efforts for post-transplant monitoring of stem cell and kidney transplant patients. With the IVDR approvals in place, Devyser is thrilled to partner with Thermo Fisher, a leading innovator in transplant diagnostics, to introduce and market these products in Europe.
As of May 26, 2022, all new medical devices sold in Europe must comply with the new IVD Regulation (IVDR) to ensure the highest level of public health protection.
The transplantation market is growing rapidly due to an aging population and increased incidence of chronic diseases. However, organ shortages globally result in many patients waiting for new organs. Kidney transplantation is the most common organ transplant, and end-stage renal disease (ESRD) affects around 2 million people worldwide. The primary causes of kidney disease include type 1 diabetes, high blood pressure, and kidney inflammation. In 2021, approximately 92,000 kidney transplantations were performed globally, providing higher patient survival and better quality of life compared to dialysis. From a health-economic perspective, kidney transplantation is also considered more favorable.