Konstanz, Germany - As of today, PrenaTest® is available in more than 70 qualified prenatal diagnostic practices and clinics in Germany, Austria, Liechtenstein and Switzerland.
PrenaTest® is a highly accurate non-invasive genetic blood test which is intended for use among women with pregnancies at high risk for fetal aneuploidy, specifically to detect fetal trisomy 21. It is a complement to other prenatal diagnostic analysis methods and can help determine whether an invasive diagnostic testing, such as amniocentesis, is actually necessary. The blood test is made available from the 12th week of pregnancy onward. Affected women with such high risk pregnancy need to undergo human genetic counseling by a qualified physician. PrenaTest® can significantly reduce the number of intervention-related miscarriages; in Germany alone it can save the lives of up to 700 children who die every year due to complications from invasive examinations.
The PrenaTest® was developed between 2009 and 2012 by LifeCodexx in collaboration with its parent company GATC Biotech and several leading prenatal centers in Germany and Switzerland. In 2011, LifeCodexx also established a licensing and collaboration agreement with Sequenom Inc., USA.
"We're very proud to see an international acceptance of our non-invasive, prenatal genetic testing technology through our successful collaboration with LifeCodexx," said Harry Hixson, Jr., Ph.D., Chairman and CEO of Sequenom. "We are pleased to see LifeCodexx providing the PrenaTest® for women who are at increased risk of carrying a child with trisomy 21."
"In the near future, the PrenaTest® will also be able to identify other chromosomal mutations such as trisomy 13 and 18," says Dr. Michael Lutz, CEO of LifeCodexx. "As the world's first biotechnology company, we have successfully received European regulatory approval with the recent CE certification."
The market launch of PrenaTest® was preceded by protracted public discussions regarding the lawfulness of the blood test. An initial expert opinion commissioned by LifeCodexx and provided by Prof. Dr. Friedhelm Hufen of the University of Mainz, concludes that the PrenaTest® is legally compliant with Germany´s constitution. All questions by the Freiburg Regional Council regarding the Medical Devices Act were conclusively answered by the end of July 2012.
Based on the use of Next Generation Sequencing technology, the noninvasive prenatal diagnostic PrenaTest® is able to reliably exclude or confirm fetal trisomy 21 from maternal blood samples. As an addition to noninvasive prenatal diagnostics, it is a risk-free alternative to common invasive examination methods such as amniocentesis. PrenaTest® is only available to pregnant women which are in the 12th week of pregnancy or later and which must have a higher risk of chromosomal alterations in the unborn child. Furthermore, in Germany, women with high-risk pregnancies will need to take advice and be informed without prejudice about human genetics by a qualified physician in accordance with the German Genetic Diagnostics Act and the guidelines of the Genetic Diagnostic Commission.???
About LifeCodexx AG /
LifeCodexx AG is a German life science company focusing on the development of clinically validated molecular diagnostic tests based on the use of next generation sequencing techniques. Last year the company has partnered with Sequenom, Inc. (USA) for the commercialization of prenatal laboratory testing services in Europe.
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