Proprietary qPCR assay planned to be ready to market during 2018
Konstanz/Berlin, Germany, April 11, 2017 – LifeCodexx AG, a leading European NIPT provider, and the Department of Obstetrics of the Charité have formed a research alliance to intensify research and development of a novel molecular genetic-based assay for the early detection of preeclampsia, a severe disorder in pregnancy characterized by hypertension and proteinuria after the 20th week of gestation. It is the cause of approximately 16 percent of all maternal deaths in developed countries and up to 25 percent of the total perinatal mortality. Since two to eight percent of all pregnancies worldwide are affected, the incidence for preeclampsia is considerably higher than for fetal trisomy 21, for example.
This collaboration builds on an ongoing research partnership between LifeCodexx AG and the University Hospital Wuerzburg (Germany) in which the partners recently demonstrated in a successful clinical proof-of principle that the proprietary qPCR-based assay developed by LifeCodexx AG clearly distinguishes between patients affected with preeclampsia and non-affected patients. Now, in the new cooperation with the Charité, leading in the field of clinical research for preeclampsia diagnosis in Germany, the aim is to predict preeclampsia at an early stage of pregnancy.
“A rapid non-invasive test that accurately predicts preeclampsia early in pregnancy will address a significant unmet medical need by identifying women at risk for the disease,” said Dr. Stefan Verlohren, Consultant at the Department of Obstetrics and Head of the Preeclampsia research group at the Charité. “A reliable early molecular genetic test would be a big step forward in better predicting the disorder, potentially reducing maternal and fetal morbidity and mortality.”
“We are excited about this new research alliance in the field of preeclampsia which will continue to establish LifeCodexx at the forefront of providing innovative prenatal care solutions by means of safe and reliable molecular genetic based tests,” comments Dr. Michael Lutz, Chief Executive Officer of LifeCodexx AG. “The positive clinical proof-of principle for a first assay version based on our qPCR-based technology platform is another key milestone following our recent CE approval for our qPCR-based PrenaTest®. Our aim is to launch the novel preeclampsia assay within the coming year.”
About LifeCodexx AG
Headquartered in Konstanz (Germany), LifeCodexx AG has been developing innovative and clinically validated non-invasive molecular genetic 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 currently performed within Germany and Switzerland in strict conformity with the highest quality standards as per the European Directive on In-vitro Diagnostic Medical Devices. Now, with the development of a novel qPCR-based assay for the reliable prediction of preeclampsia early in the pregnancy, LifeCodexx AG will start to expand its product and service portfolio into the area of integrated pregnancy and prenatal care solutions.
About Charité – Universitätsmedizin Berlin
With a total of 3,001 beds, Charité – Universitätsmedizin Berlin is one of the largest university hospitals in Europe. Charité spans 4 campuses and comprises approximately 100 Departments and Institutes. In 2016, Charité treated more than 146,000 inpatient and more than 694,000 outpatient cases. With approximately 17,100 staff employed across the Charité group of companies, Charité is one of the largest employers in Berlin. The areas of research, teaching, and health care delivery are intricately linked, resulting in a working relationship that is characterized by interdisciplinary cooperation. In 2016, Charité was able to secure more than €153 million in third-party funding for research and teaching. With approximately 7,000 future physicians and dentists currently enrolled in degree courses, Charité is one of the largest medical faculties in Germany.
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