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 from tube to a LabonaChip format. This family will consist of three research systems chosen to cover all prenatal diagnosis models:
- ANGELAB1 Instrument. This system will use a LabonaChip to extract fetal DNA from the mother´s plasma based on differences in Methylation pattern between fetus and mother and captured by specific magnetophoresis, plus real time Polymerase Chain Reaction (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 Instrument. It will use a LabonaChip to carry out methylated DNA immunoprecipitation (MeDIP) for fetal DNA extraction from mother´s blood and qPCR for Aneuploidies of chromosomes 13, 18, 21, X and Y. It will initially be used to screen high-risk pregnancies and later for population screening.
- ANGELAB3 Instrument. This system will use the DNA sample provided from ANGELAB1 or ANGELAB2 and it will carry out digital PCR on a LabonaChip to detect multiple mutations such as Cystic Fibrosis. It will be used for population screening purposes.
Most of the systems will 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 LabonaChip 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. The LPPL is envisioned to serve as a platform for the manufacture of any polymer based LabonaChips.
This project will end with the implementation of these three diagnostic systems as pilot routines in two Hospitals through a technical validation of 400 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.