Successful start of the clinical validation study of the non-invasive, prenatal diagnostic test for the determination of trisomy 21
Method based on Illumina HiSeq 2000 validated
Constance, Germany – 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 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.
“Our method allows pooling of at least seven samples for parallel analysis on the HiSeq 2000,” said Dr. Michael Lutz, CEO of LifeCodexx AG, “in this manner we can sink the costs per analyzed sample by more than 50 percent. We are right on our schedule with the validation study and are confident that we will be able to launch the prenatal diagnostic test onto the market as planned at the end of 2011.”
GATC Biotech und LifeCodexx will present the results of their current studies at the World Congress in Fetal Medicine on Malta in June as well as at the Conference of the European Cytogenetics Association in Porto, Portugal, in July.