Projects

This EU-FP7 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 Lab-on-a-Chip format. This family will consist of three research systems chosen to cover all prenatal diagnosis models: • ANGELab1. This system will use a Lab-on-a-Chip 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 Lab-on-a-Chip to carry out immunoprecipitation (MeDIP) for fetal DNA extraction from mother´s blood and real time Polymerase Chain Reaction (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 Lab-on-a-Chip to detect: multiple mutations CF, 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 Lab-on-a-Chip Pilot Production Line (LPPL) that will provide a sustainable and economic Lab-on-a-Chip 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 Lab-on-a-Chips. The LPPL is envisioned to serve as platform for the manufacture of any polymer based Lab-on-a-Chips. 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. This task dimension will allow us to validate the systems against CE mark standards (ISO 15189:2007 and ISO 13485:2003) including the LPPL. For more information you can watch a video on Youtube: http://www.youtube.com/watch?v=C-MlQgPycqw&list=UUTH3xiv2Z9BxbvucvFg2YZg&index=1&feature=plcp