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LifeCodexx AG Reports Successful Proof-of-Principle of Innovative PCR-based NIPT Assay

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Breakthrough potential as affordable NIPT solution on global basis

Constance, Germany, March 26, 2015 / B3C newswire / -- 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.


About LifeCodexx AG
Headquartered in Konstanz (Germany), LifeCodexx AG has been developing innovative and clinically validated non-invasive diagnostic tests based on the newest molecular analytical methods since 2010. With the PrenaTest®, Europe's first non-invasive prenatal test (NIPT) for the determination of the most common chromosomal disorders in unborn children, launched in 2012, LifeCodexx AG has been changing prenatal diagnostics considerably. The test is performed within Germany in strict conformity with the highest quality standards as per the European Directive on In-vitro Diagnostic Medical Devices.


Contact

Elke Decker, MSc. MBA
Director Strategic Marketing & Corporate Communications
Tel. +49 (0) 7531 97 69 461
This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 

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