NEW YORK – Swedish diagnostics firm Devyser announced Monday that its noninvasive fetal rhesus D (RHD) screening test has received Class D certification under Europe's In Vitro Diagnostic Regulation. Class D is the highest-risk class under the IVDR.
The qPCR-based test is used to determine the fetal RHD status in maternal plasma starting from week 10 of pregnancy. The assay was approved for marketing in Canada in 2023.
"National and regional screening programs present significant opportunities for Devyser RHD, one of our fastest-growing products, with an increasing number of users in Europe," Devyser CEO Fredrik Alpsten said in a statement. "We are confident that this approval will further enhance the growth potential of this product."
Women with an RHD-negative blood type may carry an RHD-positive fetus, which can cause a mother to produce anti-D antibodies against the RHD antigen, resulting in pregnancy complications.