A huge step towards IVDR certification for our FetoGnost® Kit RHD

A huge step towards IVDR certification for our FetoGnost® Kit RHD

Our FetoGnost® Kit RHD has taken another step towards IVDR certification. Our bestseller is currently undergoing a Class D certification process at QMD Services. The required positive Expert Panel Review from the EMA (European Medicines Agency) has also been received. Keep your fingers crossed for a successful certification in early 2025!

FetoGnost® Kit RHD allows a rapid, sensitive and non-invasive detection of the fetal rhesusfactor D (RHD) gene in samples purified from maternal plasma of RhD-negative pregnant women. This diagnosis can prevent the unnecessary treatment of anti-D prophylaxis.


If a Rhesus D negative mother becomes pregnant with a Rhesus D positive child, an immune reaction and Rhesus incompatibility may occur between mother and child. There is a lower risk for the child during the first pregnancy, but during the second pregnancy the mother’s antibodies can pass through the placenta and attack the unborn child’s blood cells.

Currently, around 40% of RhD-negative pregnant women are given anti-D prophylaxis, although this is not clinically necessary, and the drug is only available in limited quantities. In addition, the use of prophylaxis always carries a residual risk of viral infection.


For more information about FetoGnost® Kit RHD, please visit our website at FetoGnost® Kit RHD or contact us at office@ingenetix.com.