Non invasive test for fetal trisomies
As Europe’s first non-invasive molecular diagnostic blood test for the determination of fetal chromosomal aneuploidies from maternal blood, PrenaTest has now successfully been validated for use in multiple pregnancies. It is the only blood test that can be used without any restriction following all methods of fertility treatment, such as IVF or egg donation, after the 9th week of gestation. The number of multiple pregnancies has steadily increased over the last years due to an increased use of fertility treatments especially with women of higher age. For these, PrenaTest is a valuable and risk-free improvement for the determination of fetal chromosomal aneuploidies given the significantly increased risk for miscarriage following an invasive diagnostic procedure like amniocentesis, compared to such risk in case of singleton pregnancies. In addition, conventional non-invasive examinations such as first trimester screening show a two to three fold increase with respect to the false positive rate. In addition, the innovative PrenaTest express is now available in other European countries, too. Th is express version of the PrenaTest provides the test results in one week and thus shortens the stressful waiting period for pregnant women to a minimum. PrenaTest determines the fetal trisomies 21, 18 and 13 from maternal blood reliably, rapidly and safely. It has successfully been validated in a total of 870 samples from singleton and multiple pregnancies in several studies and provides a clear result in 99.8 % of all performed analyses. With its low false positive rate of 0.1% it further clarifies early diagnosis of fetal malformation and therefore reduces the number of unnecessary invasive examinations of non-affected pregnancies. PrenaTest is for pregnant women who are in the 9th week of gestation (W 9 + D 0) and who have an elevated risk of trisomies in the unborn child. Several statutory as well as private health insurance funds in several countries already cover the costs for the analysis. The PrenaTest analysis is exclusively performed in Germany (Constance) in strict compliance with the high quality standards required by the European In Vitro Diagnostic Directive.