IVDR | March 1, 2023
Devyser, the pioneering leader in diagnostic solutions, launches today its first IVDR-certified product. Devyser Compact is a rapid genetic test for prenatal chromosome testing and the first of its type to be approved under the new more comprehensive regulation that came into force in May 2022. The original product was first launched in 2006 and is today the golden standard in prenatal testing in many European countries.
- We´re proud to announce the launch of our first IVDR product on the market. The launch is proof of our hard work to transition to IVDR, and our long-term commitment to quality and patient safety. To our customers it´s a reassurance that we will continue to provide safe and reliable products, says Theis Kipling, CCO, Devyser.
Devyser Compact, provides efficient and sensitive detection of chromosomal abnormalities. In addition to detecting the most common syndromes, i.e., Down´s syndrome, the test includes patented technology for reliable diagnosis of Turner syndrome. The new version offers laboratories a safe and easy transition to IVDR. The Devyser test kit with a single tube solution is easy to use which minimizes hands-on time, analysis time and the risk of sample mix up.
Devyser Compact will be available in all native English-speaking countries from March 1st. Other markets will have availability during March. The certification was issued by the notified body TÜV SÜD in August 2022 and covers Devyser Compact and Devyser´s quality management system.
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.
