New data confirms clinical benefit – PrenaTest® reduces the number of invasive prenatal diagnostic examinations by almost 70 %
Non-invasive prenatal test from Germany has the lowest non-reportable rate worldwide to date
Constance, Germany – A recent clincial study at the University Hospital in Basel (Switzerland) revealed that invasive examinations declined by almost 70 % within the first nine months after the introduction of the PrenaTest® in Switzerland. This result confirms the clinical value of the PrenaTest® as Europe’s first non-invasive molecular genetic prenatal diagnostic test for the determination of fetal trisomies 21, 18 and 13 from maternal blood. A total of 951 women were included in this independent retrospective study after first trimester screening and who had an elevated risk for fetal trisomies.
LifeCodexx’ own data collection with over 8,200 PrenaTest® analysis carried out since market introduction with blood samples from pregnant women at risk clearly underlines these results. In 98% the PrenaTest® results were inconspicuous so that the respective pregnant women did not need to undergo further invasive testing with the risk of miscarriage. Trisomies 13, 18 or 21 were determined in about two percent of the examined blood samples. The false-positive rate was 0.1 %. The current data as well as data from the clinical validation of the PrenaTest® for multiple pregnancies will be presented during the Annual Meeting of the German Society of Human Genetics which will be held this week in Essen (Germany).
“One of our main goals has always been to establish the PrenaTest® as a risk-free alternative to common invasive examination methods such as amniocentesis. Data from the new Swiss study and our own results clearly show that we made considerable progress towards this goal,” said Dr. Michael Lutz, CEO of LifeCodexx. “Moreover, we are very proud about our non-reportable rate of only 0.5 %. To our knowledge, this appears to be the lowest non-reportable rate documented today worldwide within the field on non-invasive prenatal testing and which is evidence for the high quality standards we are applying at LifeCodexx.”
With its CE-marked software pursuant to the In-vitro Diagnostics Directive, PrenaTest® is the only marketable, non-invasive molecular genetic blood test in the European Union to detect fetal trisomies. The analysis is exclusively performed in Germany in LifeCodexx’ certified laboratory in Constance, Germany.
PrenaTest®, Europe’s first non-invasive, molecular genetic prenatal test, 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 analyzes. 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. Thus, PrenaTest® is an innovative non-invasive prenatal diagnostic tool which complements common prenatal examinations, and, in contrast to invasive methods such as amniocentesis, does not carry the risk of procedure-related fetal losses. 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 (Konstanz) in strict compliance with the high quality standards in accordance with the European In Vitro Diagnostic Directive.