LifeCodexx AG, Konstanz, Germany, has received CE marking of its PrenaTest BioIT analysis software based on an innovative methylation-specific quantitative polymerase chain reaction (qPCR) assay for the detection of fetal trisomy 21. The proprietary PrenaTest software is now cleared for the analysis of data from next-generation sequencing (NGS) as well as from qPCR assays.

The quantitative noninvasive prenatal test (qNIPT) was developed and validated in studies involving around 2,500 maternal blood samples. A recent blinded prospective validation study with close to 1,000 samples demonstrated a 100% concordance with test results obtained from NGS-based PrenaTest, for which a recent prospective clinical follow-up study with more than 2,200 patients also confirmed 100% test accuracy for fetal trisomy 21.

Moreover, the performance evaluation demonstrated that the new qNIPT provides reliable results from blood samples with a fetal fraction as low as 2.4%. The latest study also confirmed additional advantages such as increased cost-efficiency and rapid turnaround time.

“This is a significant innovative step in the field of noninvasive prenatal testing,” says Wera Hofmann, chief scientific officer of LifeCodexx AG. “Ten years after the first publication about the use of fetal epigenetic markers for the noninvasive prenatal detection of a fetal trisomy, we are proud to bring such an epigenetic and qPCR-based NIPT finally into clinical practice.”

“Our smart qNIPT will allow more pregnant women to opt for NIPT as a reliable and affordable prenatal testing method which provides rapid results under highest quality standards,” says Michael Lutz, CEO of LifeCodexx AG. “As our qNIPT is based on the most widely used platform within the molecular diagnostic space, this technology will offer the advantage of simplified integration into the lab routines of many laboratories around the world.”

For more information, visit LifeCodexx AG.