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GATC和LifeCodexx宣布,其唐氏綜合癥診斷項目已進入臨床驗證階段
德企GATC和LifeCodexx宣布,其唐氏綜合癥診斷項目已進入臨床驗證階段。該技術基于二代測序,屬無創診斷。初期有望收集150個樣品,并最終達到500個用于驗證。他們之前已經用38個樣品在HiSeq測序平臺測試通過。HiSeq平臺也是他們的商業平臺。另外,Fluidigm目前擁有該技術的專利。
Successful start of the clinical validation study of the non-invasive, prenatal diagnostic test for the determination of trisomy 21
28 | 06 | 11
Method based on Illumina HiSeq 2000 validated
In conjunction with several Central European prenatal centers, scientists at GATC Biotech AG andLifeCodexx AGhave 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.
Contact:
LifeCodexx AG
Dr. Michael Lutz
Chief Executive Officer
m.lutz@lifecodexx.com
+49 (0) 7531 81 60 15GATC Biotech AG
Elke Decker
Director Strategic Marketing & Corporate Communications
e.decker@gatc-biotech.com

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