Date: 2011-06-28
Type of information:
phase: validation study
Announcement:
Company: GATC Biotech (Germany) LifeCodexx (Germany)
Product: Trisomy 21 Diagnostic Test (LifeCodexx PraenaTest™)
Action mechanism: The test detects fetal trisomy 21 (Down’s syndrome) and is based on the sequencing cell-free fetal DNA from maternal blood.
Disease: Trisomy 21
(Down's syndrome)
Therapeutic area: Genetic diseases
Country: Central Europe
Trial
details: The clinical study was conducted jointly with several Central European prenatal diagnostics centers and scientists at GATC Biotech AG and LifeCodexx AG. Currently, the only reliable way of diagnosing chromosomal irregularities during pregnancy is to use invasive prenatal methods. This causes miscarriage in about one per cent of these risky surgical procedures.
Latest
news: In conjunction with several Central European prenatal centers, scientists at GATC Biotech AG and LifeCodexx AG have begun the clinical validation study of a non-invasive, prenatal diagnostic test based on next generation sequencing.
The test detects fetal trisomy 21 (Down’s syndrome) and is based on the sequencing cell-free fetal DNA from maternal blood. More than 150 samples could be collected within a short time. At least 500 samples are required for the study. To improve cost efficiency and productivity, the method was successfully validated beforehand on the IlluminaHiSeq 2000 Next Generation Sequencing System with 38 samples.
* On January 10, 2012 , GATC Biotech AG and its subsidiary LifeCodexx AG announced that they have successfully completed the recruitment of over 500 blood samples required for the clinical study of the non-invasive prenatal diagnostic test for the determination of trisomy 21 (LifeCodexx PraenaTest™).
The results of the study will be available in the first quarter of 2012. Then, following CE certification, the LifeCodexx PraenaTest™ will initially be introduced in German speaking countries in the second quarter of the year.
