To be generally applied after IVF, egg donation and other infertility treatments
Constance, Germany, February 6, 2014 / B3C newswire / – 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. To date, several thousand PrenaTest® analysis have been been successfully performed in singleton pregnancies.
The number of multiple pregnancies has steadily increased in Germany 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.
"We are happy to report that we correctly classified all trisomy cases with the PrenaTest® in a validation study which included 62 twin and triplet pregnancies,” said Dr. Michael Lutz , CEO of LifeCodexx AG. "With the successful validation of the PrenaTest® for multiple pregnancies, we have set high standards again in this innovative field of non-invasive prenatal diagnosis."
In addition, the innovative PrenaTest®express is now available in other European countries, too. This 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. In Germany about every fourth patient opts for the express version.
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.
Elke Decker MSc. MBA
Director Strategic Marketing, Communication & Business Administration
Tel. +49 173 31 30 780