IVDR | July 17, 2023
Devyser’s novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplant patients fulfill IVDR requirements in Europe. These tests are the first post-transplant monitoring NGS products to be approved under the new, more comprehensive regulation that came into force in May 2022 and confirm Devyser’s two NGS products meet the established safety, efficacy, and quality requirements.
Thermo Fisher Scientific, Devyser’s commercialization partner for these products, can now market and sell the regulatory-approved products in all European markets, in accordance with their launch plans.
The IVDR approved products are One Lambda Devyser Chimerism, for early detection of mixed chimerism in stem cell transplant patients, and One Lambda Devyser Accept cfDNA, a novel test for the detection of donor-derived cell-free DNA in blood samples from kidney transplant patients.
“Over the last two and half years, we have been working extensively in developing our products for post-transplant monitoring of stem cell and kidney transplant patients. We have seen much interest in the products, and many have been waiting for these regulatory approvals. With the European IVDR approvals in place, we are excited to partner with Thermo Fisher, the leading innovator in transplant diagnostics, in order to market and sell these products in Europe”, says Fredrik Alpsten, CEO at Devyser.
From May 26, 2022, all new medical devices to be 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 a larger aging population and higher incidence of chronic diseases. However, there is a shortage of organs globally, and many patients are currently on waiting lists for new organs. Kidney transplantation is the most common organ transplantation. End-stage renal disease (ESRD) affects 2 million people globally, and the most common causes of kidney disease are type 1 diabetes, high blood pressure, and kidney inflammation. In 2021 approximately 92,000 kidney transplantations were performed globally. Compared to dialysis, kidney transplantation provides higher patient survival and superior quality of life. From a health economic perspective, it is also more favorable.
For more information, please contact,
Fredrik Alpsten, CEO
Mail: fredrik.alpsten@devyser.com
Telephone: +46 70 667 31 06
Theis Kipling, CCO
Mail: theis.kipling@devyser.com
Telephone: +46 703 598 07 76
About Devyser
Devyser develops, produces, and sells genetic testing kits and services to laboratories in more than 50 countries. The products are used for advanced DNA testing in the hereditary disease, oncology, and transplant fields, to enable targeted cancer treatment, the diagnosis of a broad range of genetic diseases, and transplant patient follow-up. Devyser’s products and unique, patented easy-to-use single-tube test simplify genetic testing processes, minimize hands-on time and deliver rapid, accurate, and trusted results. Our aim is to ensure every patient gets a correct diagnosis in the shortest possible time.
Devyser was founded in 2004 and is based in Stockholm, Sweden. We have 8 own sales offices in Europe and the US where we also have our own CLIA lab in Atlanta, Georgia. In August 2022 we received certification for our quality management system and Devyser Compact under the new comprehensive European IVD Regulation.
Devyser’s shares are listed on Nasdaq First North Growth Market (ticker: DVYSR). The company’s Certified Adviser is Redeye AB.
