The novel qNIPT determines the differences in methylation patterns of specific gene regions of the maternal and fetal DNA. Certain gene regions in maternal DNA are hypo-methylated whereas the same gene regions are hyper-methylated in fetal DNA. These methylation specific gene regions are used as DNA biomarkers for the determination of fetal trisomy 21.
A bioinformatic algorithm, integrated into the IVD software PraenaTest® DAP.plus, was developed to analyze the qPCR data. The algorithm has has been manufactured in accordance with the technical documentation set out in Annex IV to Directive 98/79/EC and it complies with the relevant requirements of the German Medical Devices Directive and Directive 98/79/EC of October 27, 1998, on in vitro diagnostic medical devices and corresponding harmonized standards.