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LifeCodexx Receives CE Mark for qPCR-Based NIPT Analysis Software

NEW YORK (GenomeWeb) – Germany-based LifeCodexx said today it has received CE marking for analysis software for a new noninvasive prenatal test for fetal trisomy 21 that is based on methylation-specific quantitative PCR.

The software, PrenaTest BioIT, is now cleared for the analysis of data from both LifeCodexx's existing next-generation sequencing-based PrenaTest and from its new methylation-specific qPCR-based qNIPT assay.

The company has developed and validated qNIPT with about 2,500 maternal blood samples. In a blinded prospective validation study with almost 1,000 samples, qNIPT demonstrated 100 percent concordance with results from the existing PrenaTest. Also, qNIPT provided reliable results from blood samples with low fetal fraction down to 2.4 percent, showed cost efficiency, and had a rapid turnaround time, according to the firm.

"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," said LifeCodexx CEO Michael Lutz in a statement.

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