LifeCodexx AG today reports the successful outcome of a proof-of-principle of its novel assay for non-invasive prenatal testing (NIPT assay) based on quantitative real-time PCR (qPCR). This NIPT assay, designed to determine fetal aneuploidies from maternal blood, will offer significant advantages, such as enhanced test performance at affordable prices, over other prenatal examination methods. The proof-of-principle study comprised 93 blood samples with eight positive trisomy 21 cases of which the assay unambiguously detected all positive samples.
“This is the first time that a widely used technology platform like PCR has been successfully applied to non-invasive prenatal testing with cell-free DNA. Our new proprietary qPCR-based assay has a clear breakthrough potential in the field of non-invasive prenatal testing on a global scale,” says Dr. Michael Lutz, CEO of LifeCodexx AG. “This innovation will further strengthen our leading position in the European NIPT market following the successful introduction of our PrenaTest®, Europe’s first non-invasive prenatal test, in summer 2012.”
“We are enthusiastic about these promising results of this feasibility study,” says Dr. Wera Hofmann, CSO of LifeCodexx AG. “Assuming successful validation in large clinical cohorts, our novel assay has the potential to become a true alternative to more expensive technologies, such as next generation sequencing or DNA analysis on microarrays. Compared to these technologies, we are confident that detection rates and false positive rates will significantly improve.”
LifeCodexx AG is currently preparing a bigger blinded validation study with the aim to launch a first CE-marked test in the second half of the year.