LifeCodexx AG today announced final top line results from a prospective Post-Market Clinical Follow-up study (PMCF) for the PrenaTest®, Europe’s first non-invasive prenatal test (NIPT).
Under the direction of Prof. Dr. med. Annegret Geipel of the University Hospital Bonn, the study compared results of the PrenaTest® for the detection of fetal trisomies 13, 18 and 21 with results from invasive testing and birth outcomes. More than 2,200 women with singleton pregnancies from Germany were included in the blinded multicenter study, which was conducted in cooperation with more than 400 physicians between February 2013 and July 2016. Final results of the Post-Market Clinical Follow-up study were presented by the University Hospital Bonn at the congress of the German Society for Gynecology and Obstetrics in October 2016.
Top line study results confirm the outstanding performance of the PrenaTest® with a detection rate for fetal trisomy 21 of 100% without any false positive results. The detection rate of all three fetal trisomies 21, 18 and 13 is 98% with a false-positive rate of 0.1%. The no-call rate of the PMCF study was in line with the no-call rate from clinical diagnostic routine which is in the range of 0.6%. Such low failure rate significantly helps to minimize delays in diagnosis and to reduce the use of invasive testing. Main medical reasons for opting for PrenaTest® were the age of the pregnant women as well as conspicuous findings from biochemical screening or ultrasound examinations.
“We are very grateful to all physicians and pregnant women who participated in this study,” said Prof. Annegret Geipel, Director of Prenatal Medicine at the University Hospital Bonn. “Thanks to their vast participation we were able to create a profound database that confirms the exceptional test accuracy of the PrenaTest®, being a highly reliable non-invasive prenatal test available today.”
“The data of the PMCF study fully confirm latest clinical performance metrics of the PrenaTest® for the three autosomal trisomies based on close to 50.000 successful analyses since its commercial launch in August 2012,” added Dr. Wera Hofmann, CSO of LifeCodexx AG. “According to these performance metrics, the PrenaTest® also shows high test accuracy for the detection of gonosomal aneuploidies and the 22q11 microdeletion, which is associated with DiGeorge syndrome.”
More than 2,500 gynecologists in the German-speaking regions offer the PrenaTest® to their patients due to its outstanding test accuracy and short turnaround time of less than a week. It is the only non-invasive prenatal test that is developed and performed in Germany in strict conformity with the highest quality standards as per the European Directive on In-vitro Diagnostic Medical Devices.