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.”[pl_blockquote cite=”Dr. Michael Lutz, CEO of LifeCodexx AG”]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. This clearly shows that the PrenaTest™ is a reliable method for the detection of fetal trisomy.[/pl_blockquote]
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.[wpdm_file id=3][wpdm_file id=4]