A New GEnetic LABoratory for non-invasive prenatal.. (ANGELab)
A New GEnetic LABoratory for non-invasive prenatal diagnosis
Date du début: 1 oct. 2012,
Date de fin: 31 mars 2017
This project will develop a family of In-Vitro Diagnostic Systems that will transfer for the first time novel Non Invasive Prenatal Diagnostic (NIPD) methods in tube to a LabonaChip format. This family will consist of three research systems chosen to cover all prenatal diagnosis models:- ANGELAB1. This system will use a LabonaChip to extract fetal DNA from the mother´s plasma based on differences in methylated pattern between fetus and mother and captured by specific magnetophoresis, plus qPCR for monogenic diseases with a known mutation for: Spinal Muscular Atrophy, Cystic Fibrosis (CF), and X-linked disorders. It will be used only for high risk population.- ANGELAB2. It will use a LabonaChip to carry out immunoprecipitation (MeDIP) for fetal DNA extraction from mother´s blood and real time quantitative Polymerase Chain Reaction (real time qPCR) for Aneuploidies of chromosomes 13, 18, 21, X and Y. It will be used for population screening purposes.- ANGELAB3. This system will use the DNA sample provided from ANGELAB1 or ANGELAB2 and it will carry out Digital PCR on a LabonaChip to detect: CF (unknown multiple mutations), b-thalassemia and achondroplasia. I will be used for population screening purposes.All systems can manage 8 samples at a time. They can be modularly assembled to themselves, offering a system adaptable to different throughput needs.The consortium will also develop and integrate a LabonaChip Pilot Production Line (LPPL):- LPPL: This pilot line setup will provide a sustainable and economic LabonChip manufacturing. Materials, processes, and their life cycle will be considered. The environmental assessment will be carried out following ISO 14044. Quality control tools will be integrated along the entire production chain of LabonaChips.This project will end with the implementation of these three diagnostic systems as pilot routines in two Hospitals through a technical validation of 700 pregnancies.
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