World's first clinical follow-up study of the non-invasive molecular genetic method has started. PrenaTest®, Europe's first non-invasive molecular genetic blood test to detect fetal trisomy 21 from maternal blood, now also tests for the existence of trisomy 13 and 18 with a high degree of accuracy. This advanced blood test fully meets the European legal requirements for medical devices and includes the necessary CE marking.
"With the expansion of the PrenaTest® to test for the fetal trisomies 13 and 18, it now detects over 90% of all relevant pathological changes caused by autosomal chromosomal disorders," says Dr. Wera Hofmann, CSO of LifeCodexx. "With this test expansion, we fulfilled a key demand of our medical partners."
"In clinical studies that assessed the extended PrenaTest® more than 99% of all blood samples yielded an accurate result. All cases of trisomy 13 and 18 were correctly classified, "said Dr. Michael Lutz, CEO of LifeCodexx AG. “This clearly shows that the PrenaTest® is a reliable method for the detection of fetal trisomy."
Since its launch, nearly 2,000 women with pregnancies at risk have opted for the PrenaTest®. In 98% of the tested blood samples the incidence of fetal trisomy 21 could be excluded and therefore the vast majority of the pregnant women could be relieved. Approximately 1.3% of the analyzed samples carried fetal trisomy 21. The analysis had to be repeated with less than one percent of the blood samples due to a low content of fetal DNA.
According to the European guidelines for medical devices, the PrenaTest® will now be evaluated in the context of a prospective clinical follow-up study. Under the direction of Prof. Dr. med. Annegret Geipel of the University of Bonn, the study will include 2,000 patients throughout Germany. It is the first follow-up study of this non-invasive molecular genetic method based on next generation sequencing.
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.
Elke Decker MSc. MBA
Director Strategic Marketing, Communication & Business Administration
Tel. +49 173 31 30 780