Devyser has secured a tender for its non-invasive fetal rhesus disease (RHD) testing product from Héma-Québec, a blood and human biological products supplier.
The order value is estimated to be more than $1.58m (Skr16m).
As part of the tender process, the company submitted a regulatory registration application for the fetal RHD testing product in Canada.
Devyser has held MDSAP certification, which is a requirement to register products in the country, since 2020.
Clinical labs can use the Devyser RHD test kit to determine fetal RHD status from maternal plasma in early pregnancy.
The unique single-exon design of the product helps to significantly simplify lab workflows and analysis.
Additionally, the user-friendly assay allows increased throughput and reduces turnaround times for labs.
The company noted that determining the fetal RHD status in pregnant women who are RHD-negative helps to avoid hemolytic disease, which is a condition that can be life-threatening for newborn babies.
Devyser CEO Fredrik Alpsten said: “This is a strategic breakthrough in the North American market, and I am very proud of the entire team who made this happen.
“National and regional screening programmes represent an important upside for us, and this award is a true confirmation of our product’s competitiveness in these large international tenders.”
Initially, the tender is valid for a duration of three years, starting next year. It also has an option to be extended for a further two years.
The award of the tender is subject to a testing period to verify and validate the product during the first half of next year.
Once the final award contract is in place, the first order from the tender is expected around the middle of the same year.