Devyser has submitted a regulatory registration application of the RHD product in Canada as part of the tender process

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The Devyser RHD product is used by clinical labs for non-invasive determination of fetal RHD status in maternal plasma as early as gestation week 10. (Credit: Cindy Parks from Pixabay)

Devyser has been awarded a tender from Héma-Québec, in Québec, Canada, for its non-invasive fetal RHD detection product, used to determine fetal RHD status from maternal plasma in early pregnancy. The tender is initially valid over three years starting in 2023, with a potential extension of two additional years. The total possible order value amounts to just over 16 MSEK.

“This is a strategic breakthrough in the North American market, and I am very proud of the entire team who made this happen”, says CEO Fredrik Alpsten. “National and regional screening programs represent an important upside for us, and this award is a true confirmation of our products competitiveness in these large international tenders.”

Devyser has submitted a regulatory registration application of the RHD product in Canada as part of the tender process. The company already holds an MDSAP certification since 2020, which is a requirement for registration of products in Canada.

The award is subject to a testing period for verification and validation during the first half of 2023 and the first order from the tender is expected around mid-2023 once the final award contract is in place.

The Devyser RHD product is used by clinical labs for non-invasive determination of fetal RHD status in maternal plasma as early as gestation week 10. Devyser’s unique technology significantly simplifies laboratory workflows and analysis. It also enables increased throughput and shortened turnaround times for the labs. Determining the fetal RHD status is important in pregnant women who are RHD-negative in order to avoid hemolytic disease, a condition that can be life-threatening for the newborn baby. Hemolytic disease of the fetus can be prevented by RHD determination combined with prophylactic treatment during pregnancy.

Héma-Québec’s mission is to efficiently meet the Québec population’s needs for blood and other high-quality biological products of human origin. Héma-Québec has over 1,400 employees, nearly 200,000 donors of blood, stem cells, mother’s milk and human tissues, as well as thousands of blood drive volunteers. Every year, Héma-Québec delivers over 800,000 biological products of human origin to Québec’s hospitals in order to meet patients’ needs.

Source: Company Press Release