About 1,000 women have opted for PrenaTest® since market launch
Over 150 prental diagnostic practices and clinics now offer the blood test for the detection of fetal trisomy 21
Constance, Germany – In the first three months after market launch, close to 1,000 pregnant women have opted for the PrenaTest®, Europe’s first non-invasive molecular genetic blood test for the detection of fetal trisomy 21. All of them were at risk for trisomy 21 in the unborn child.
The pregnant women were mainly from Germany, Austria and Switzerland, but also from other European countries. Meanwhile over 150 qualified prenatal practices and clinics in Germany, Austria, Liechtenstein and Switzerland are now offering the PrenaTest®, more than twice as many as in August this year. Several private health insurance companies in Germany have already reimbursed the cost for the PrenaTest®.
Evaluation of all PrenaTest® analyses carried out to date shows that the vast majority of 97 % of the tested women could be relieved with regard to the presence of trisomy 21 in their unborn child. Only 1.5 % of the analyzed blood samples carried fetal trisomy 21. As far as known, these positive results have been confirmed by amniocentesis in accordance with the recommendations of the Bundesverband niedergelassener Pränatalmediziner (BVNP), the German Society of Human Genetics (gfh) as well as the International Society for Prenatal Diagnosis (ISPD). Another 1.5 % of the blood samples could initially not be reported primarily due to a low amount of cell-free fetal DNA.
„These results clearly show how useful the PrenaTest® is in particular as a complement to the first trimester screening, because significantly less women actually need to undergo invasive testing and could be relieved quite early during their pregnancy,” said Dr. Wera Hofmann, Chief Scientific Officer of LifeCodexx AG. “Having this new method now established as a high quality lab routine process, we are currently working hard to further reduce the turnaround time between sample receipt and reporting. We aim to give the patient clarity as quickly as possible.”
“The number of blood tests carried out until now shows that physicians increasingly trust the PrenaTest® as a guidance for the woman for or against an invasive diagnostic procedure,” said Dr. Michael Lutz, Chief Executive Officer of LifeCodexx AG. “Soon the test will be able to reliably detect trisomies 13 and 18, too. Then the physician will be able to detect the three most common types of autosomal trisomy without any risk for the pregnant woman and her unborn child.”
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. LifeCodexx is currently evaluating the expansion of test availability to other countries of the European Union.
Based on the use of Next Generation Sequencing technology, the noninvasive molecular genetic 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 / www.lifecodexx.com
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.