Devyser announces 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.

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