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Following the successful market launch of the PrenaTest® in Germany, Austria, Liechtenstein and Switzerland, Europe’s first non-invasive molecular genetic blood test for the detection of fetal trisomy 21 from maternal blood is now available in selected gynecologic practices and prenatal diagnostic clinics in Hungary, Bulgaria, Ukraine, Russia and Turkey. Following genetic counseling, the blood test is exclusively available to pregnant women at risk for fetal trisomy 21 and from 12 weeks of gestation.
Over the coming weeks, the PrenaTest® will also be launched in Albania, Bosnia Herzegovina, Croatia, Estonia, Latvia, Lithuania, Macedonia, Montenegro, Poland, Romania, Serbia and Slovenia as well as in Bahrain, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, the United Arab Emirates, and India.
For all countries, LifeCodexx closed cooperation agreements with experienced laboratory service and in-vitro-diagnostic providers which will support and provide the PrenaTest® to qualified practices and clinics in the respective countries. Addresses of partnering practices and clinics can be found on LifeCodexx' website. The list will be constantly updated.
“Many women with risk pregnancies for fetal aneuploidies such as trisomy 21 have a strong interest in the PrenaTest®. This is what we learned since we launched the test three months ago. Together with our clinical partners we are now able to provide our non-invasive molecular genetic blood test to these women in their own countries,” said Dr. Michael Lutz, CEO of LifeCodexx AG. “One important aspect is that our blood test is in full compliance with the high quality standards of the In-Vitro Diagnostics Directive of the European Union.”
The PrenaTest® is the only non-invasive molecular genetic blood test for the detection of fetal trisomy 21 in Europe, which has successfully completed the conformity assessment procedures required for CE marking, thus proven its efficiency in terms of the in-vitro diagnostics directive of the European Union. In the first three months after market launch in August 2012, around 1,000 PrenaTest® analyses had already been carried out. Early 2013 LifeCodexx’ blood test will be able to detect trisomy 13 and 18, too. As required by law, the new test extension has also been developed in accordance with the European In Vitro Diagnostic Directive and will include CE marking of the data analysis pipeline.
The non-invasive molecular genetic PrenaTest® is able to detect fetal trisomy 21 with a high degree of accuracy from maternal blood based on the use of next generation sequencing techniques. With its low false positive rate of 0.5% it further clarifies early diagnosis of fetal malformation and therefore reduces the number of unnecessary invasive examinations of non-affected pregnancies. Thus, PrenaTest® is an innovative non-invasive prenatal diagnostic tool which complements common prenatal examinations, and, in contrast to invasive methods such as amniocenteses, does not carry the risk of procedure-related fetal losses.
In accordance with the recommendations of the “ German Association of private physicians of prenatal medicine” (Bundesverband niedergelassener Pränatalmediziner, BVNP), the German Society of Human Genetics (gfh) or the International Society for Prenatal Diagnosis (ISPD), positive test results need to be further clarified diagnostically by means of an invasive examination. PrenaTest® is exclusively for pregnant women who are in the 12th week of pregnancy or later and have a risk of trisomy 21 in the unborn child. Furthermore, in Germany, women opting for the PrenaTest® will need to take unbiased information and genetic counseling as non-directive assistance in their decision making process by a qualified physician in accordance with the German Genetic Diagnostics Act and the guidelines of the Genetic Diagnostic Commission.
About LifeCodexx AG
GATC daughter 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. In 2011 the company has partnered with Sequenom, Inc. (USA) for the commercialization of prenatal laboratory testing services in Europe.