LifeCodexx AG has reported the successful validation of its innovative qPCR-based NIPT assay designed to determine fetal trisomy 21 from maternal blood. The blinded study with close to 700 samples demonstrates clearly that the accuracy of the new qPCR-based PrenaTest® is superior to the accuracy of the combined test and comparable to the performance of current non-invasive prenatal tests based on next generation sequencing or microarrays.
Moreover, the new assay will offer two compelling advantages over existing NIPT assays. Results will be available in 48 to 72 hours upon sample receipt in the laboratory. In addition, the qPCR assay will provide a substantially increased cost-efficiency compared to other NIPT assays given its simplified analysis method. Thus, more pregnant women will be able to opt for NIPT as a reliable and safe alternative to invasive examinations.
“For the first time leading medical associations in Europe recently recommended that NIPT can now be used as primary screening for fetal trisomy 21 in all pregnant women of any age or risk,” said Dr. Wera Hofmann, CSO of LifeCodexx AG. “Due to its rapid turnaround time and low cost, our qPCR-based PrenaTest® will be the ideal non-invasive prenatal test which will allow doctors to implement the new recommendations into their clinical routine.”
“The market launch of our innovative qPCR-based PrenaTest® is planned early 2016 following CE marking,” said Michael Lutz, CEO of LifeCodexx AG. “This new offer will greatly enhance our existing and well-established PrenaTest® service portfolio based on next generation sequencing and strengthen our position as a leading NIPT provider located in Europe.”
The data of the clinical validation study will initially be presented on the occasion of the upcoming FMF Advances Course in London beginning of December this year, followed by several other conferences in the near future.