Project: Full-Integrated Early-Life Automate Platform
Each year, worldwide, 138.2 million people are born. Each of these people needs to be diagnosed, treated and cared for congenital and others that may hamper his future life. _x000D_For many years, diagnostic and pharmaceutical industries have regarded the child as a miniature adult. However, it appears that these babies, these children have different physiological and psychological characteristics. Between 2000 and 2003, the competent authorities of the United States and the EU has been concerned with this fact and have introduced legislation requiring manufacturers to take into account the "paediatric" specificity in the registration of drugs and devices medical. Additionally, the market is in emerging countries where Asian countries are predominant, an increase linked to improved well-being._x000D_From the perspective of sampling technology, the low weight of the individuals to whom we must draw blood requires the use of appropriate methods. Among these methods, the technique known as "Dried Blood Spot" (DBS) is favoured and recommended by international institutions such as CDC (Control Disease Centre) in Atlanta. By simple finger or heel prick of the child, a few drops of blood are placed on a special filter paper (Whatman 903). This technique solves the difficulties of the blood in children who experience it as particularly traumatic. By cons, diagnostic assays need to be adapted to this type of sample and physiological values of the child._x000D_It is also important to notice that the DBS method is becoming more and more interesting apart from those "children". Indeed, due to its specificities, this technique has numerous advantages and applications:_x000D_• low cost,_x000D_• increasing of stability,_x000D_• low volume needs,_x000D_• Storage at room temperature,_x000D_• availability of genetic material (DNA), _x000D_• medical sites relocated, _x000D_• screening of population, _x000D_• adults suffering from a fear of blood tests._x000D_In this context, market and technical growth is part of the Consortium strategy. In addition, ZENTECH, Consortium leader, is already commercially active in the market of in vitro diagnostics of early life stages both in Europe, Asia and South of America (figure 1)._x000D_The global IVD (In Vitro Diagnostic) sector is innovative and invests on average 10% of its turnover in research and development. The CO areas of development of IVD industries are: _x000D_• Automation and robotics (ELISA - CLIA),_x000D_• Mixed analytical biochemistry and immunoassay platforms,_x000D_• Biology at the bedside of the sick (point of care),_x000D_• Confirmatory diagnostic,_x000D_• Multiplexing,_x000D_• The new settings._x000D_The trend in clinical laboratories is a centralization of assays, through the creation of technical platforms, using automated and versatile machines (figure 2)._x000D_This instrumentation of assay methods does not facilitate the use of low-volume blood samples such as DBS. This isolates the neonatology and paediatric diagnostic services in a technological "no man's land". _x000D_Ps of the consortium are, in their field, very involved in this theme. In the case of ZENTECH (consortium leader), because of its size, it does not have the opportunity to develop and to have an automated machine for clinical use. Therefore, this is made available via P companies specialized in the development of this type of automatic machine. This type of companies whose automate is available for use by other companies is few. As a result:_x000D_• The company is faced with a lack of flexibility (modifications are difficult to obtain),_x000D_• The machine is not owned by the company and therefore is not specific, software and hardware are not available, kits must adapt to the machine and not the machine to kits._x000D__x000D_A status and analysis of the market indicate that there is no “plug and play” automated machine that can analyse Dry Blood Spot. A screening of patents available on the website of the European Patent Office shows that this type of equipment has not been the object of a patent application. It is therefore very likely that the consortium filed a patent application in that direction._x000D__x000D_Hence, based on the real necessity for an automated machine able to analyse DBS and the necessity of having a system that can be used and adapted for specific kits, the launch of FIELAP project has been initiated by the Consortium._x000D_
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Acronym
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FIELAP
(Reference Number: 7489)
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Duration
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01/10/2012 - 30/09/2015
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Project Topic
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The project aims to design and develop an automated integrated "plug and play" for management and full analysis of DBS type blood samples for the early life which does not exist. Emergency analysis will also be possible. Flexible, it could handle multiple sessions.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 8
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Project partner
