Devyser’s Fetal Test Gains IVD Regulation Approval

Sweden-based Devyser’s Fetal RHD (Rhesus factor D) test has been certified as complaint with the EU’s In Vitro Diagnostic Regulation (IVDR).

The highly accurate test indicates if the fetus has a protein known as D antigen on the surface of its red blood cells and if the blood type differs from the mother’s — which can occur because children inherit a mix of their parents’ genes.

It took two years for the noninvasive prenatal test to meet the more comprehensive requirements of the IVDR, the company said.

Devyser is specialized in diagnostic kits for complex DNA testing within hereditary diseases, oncology and transplantation.