Fetal RHD screening NIPT | May 12, 2023
Devyser is today announcing that its product for non-invasive fetal RHD testing has been granted regulatory approval in Canada. Devyser already has a contract with Canada’s Héma-Québec to deliver RHD tests.
The product approval by Health Canada means that it meets the established safety, efficacy and quality requirements for products marketed and sold in Canada. Devyser has had MDSAP approval for the quality management system since 2020, which is a requirement for product registration in Canada. The RHD test is Devyser’s first approved Class III IVD product in Canada.
“Approval is needed so that we can deliver on our contract with Héma-Québec, which is an important part of our investment in the North American market. Héma-Québec will shortly launch tests to verify and validate the product, and then start placing orders. Approval for registration will hopefully pave the way for increased sales of RHD tests in Canada”, says Fredrik Alpsten, CEO at Devyser.
The regulatory approval application was submitted as part of the procurement process connected with the company’s 2022 contract with Héma-Québec, an exclusive supplier of blood products in the Quebec region. The contract will initially run for three years, and may potentially be extended for another two years. The total potential order value amounts to just over SEK 16 million.
Devyser’s RHD product is used by diagnostic laboratories for the non-invasive determination of the RHD status of fetuses from maternal blood samples. It is important to determine the RHD status of fetuses for pregnant women who are RHD negative to avoid hemolytic disease, a condition that can be life-threatening for newborns. Hemolytic disease can be prevented through the early determination of fetal RHD status and prophylactic treatment during pregnancy.
The information was submitted for publication, through the agency of the contact persons below, on May 11, 2023 at 16:15 CET.
For more information, please contact:
Fredrik Alpsten, CEO
Email: fredrik.alpsten@devyser.com
Telephone: +46 70 667 31 06
Sabina Berlin, CFO
Email: sabina.berlin@devyser.com
Telephone: +46 73 598 07 76
About Devyser
Devyser develops, manufactures and sells diagnostic solutions and analysis services to clinical laboratories in more than 50 countries. Our products are used for complex genetic testing in the hereditary disease, oncology and transplant fields, to enable targeted cancer treatment, the diagnosis of a large number of genetic diseases, and transplant patient follow-up. Devyser’s products, and unique, patented solution requiring only one test tube, simplify genetic testing processes, improve sample throughput, minimize hands-on time and deliver rapid results. Our goal is for every patient to receive a correct diagnosis in the shortest possible time.
Devyser was founded in 2004 and is based in Stockholm, Sweden. The company has eight in-house sales offices in Europe and the US, and a CLIA laboratory in Atlanta, Georgia. In August 2022, Devyser's quality management system and Devyser Compact were certified according to the IVDR.
Devyser’s shares are listed on the Nasdaq First North Premier Growth Market Stockholm (ticker: DVYSR). The company’s Certified Adviser is Redeye AB.
