Konstanz, November 14, 2016 - LifeCodexx AG Laboratories today announced the final results of the clinical trial (PMCF) analysis of PrenaTest®, the first non-invasive prenatal test in Europe (NIPT).
Under the direction of Prof. Dr. Annegret Geipel from the University Hospital Bonn, a comparative study of the PrenaTest® results for fetal trisomy 13, 18 and 21 and the birth results of the women who took part in the study was carried out. The blinded, multicenter study was conducted in collaboration with more than 400 physicians throughout Germany, involving more than 2,200 women with singleton pregnancies between February 2013 and July 2016. The final results of the clinical study were presented by the University Hospital Bonn at the German Society of Obstetrics and Gynecology congress in October 2016.
The study confirms the validity of the PrenaTest® assay with 100% accuracy in detecting fetal trisomy 21 without false positives. The accuracy of detecting all three fetal trisomies (21, 18, and 13 chromosomes) is 98% with a false-positive rate of 0.1%. The failure rate of the study was in accordance with clinical diagnostic procedures, which is in the range of 0.6%. This low percentage significantly helps to minimize delays in diagnosis and reduce the use of invasive testing methods.
The main medical reasons for choosing PrenaTest® were the age of the pregnant women and the results of the biochemical screening or ultrasound.
"We are very grateful to all the doctors and pregnant women who participated in this study," said Professor Annegret Geipel, director of the Department of Prenatal Medicine at the University Hospital Bonn. "Thanks to their participation, we were able to build a solid database that confirms the exceptional accuracy of the PrenaTest® study."
"The study data (PMCF) fully confirms the latest clinical performance of PrenaTest® for the three autosomal trisomies based on nearly 50,000 successful test results since its commercial launch in August 2012," added Dr. Wera Hofmann, scientific director of LifeCodexx AG. "Consistent with these results, PrenaTest® also shows high accuracy in detecting sex chromosome aneuploidies and 22q11 microdeletions, which are associated with DiGeorge syndrome."
More than 2,500 gynecologists in the German-speaking regions offer PrenaTest® to their patients due to its high accuracy and fast testing times. It is the only non-invasive prenatal test that is developed and manufactured in Germany in strict compliance with the highest quality standards according to the European Directive on In-vitro Diagnostic Medical Devices.
Translation from www.lifecodexx.com
