An EU-funded project to create a printed electronic, cholesterol measuring diagnostic device has been announced.
The Smart Integrated Miniature Sensor (SIMS) project will create a single-substrate, disposable device over the next three years, which can read a blood sample and analyse cholesterol levels.
The technology is aimed at the point-of-care (POC) diagnostics market, allowing people to buy an off-the-shelf product and check their cholesterol at home. Such a device could be commercialised by project partner Alere, a diagnostics company.
Project coordinator Tony Killard, a principal investigator at the Biomedical Diagnostics Institute of Dublin City University (DCU), explains: 'Our commercial partner Alere sees cholesterol testing as a core part of its diagnostics platform. There are devices that do this sort of testing at a professional level, but Alere want to get that out to POC at a personal or home use level.'
Single substrate
The various elements of the organic electronic device, such as the readout display and the integrated battery, will need to be adapted so they can be added to a single substrate.
Killard adds: 'The technical goal is to integrate these items on a single substrate, without one component's production process ruining the component that went before it.
'As there are different materials requirements for each component - such as deposition, solvents used, stability - this will be an important area of the project.'
Components are provided by printed electronics developers such as Ntera and prelonic. Other partners are VTT in Finland and The University of Liverpool.
Demonstrator devices will go into pre-clinical trials in the final year of the project. If the technology remains suitably similar to the more expensive cholesterol diagnostic tools currently available, the new device may be fast-tracked into the market.
'If we adhere at to FDA regulatory requirements as we develop this, we believe we can get FDA clearance as part of a "clear waiver" - which means that, because the device does the same type of measurement at least as well as one on the market, it is acceptable,' says Killard.
Volume
Once the €3 million project is completed in 2013, further work will need to be done to manufacture these devices on a commercial scale, though Austrian firm prelonic (whose CEO Friedrich Eibensteiner spoke exclusively to +Plastic Electronics magazine in Volume 2, issue 6) could sustain some volume production in the future, says Killard.
He comments: 'The next question after we have demonstrated this is 'Who's going to manufacture these devices?' In the intermediate stage, prelonic will be key in terms of a production line.'
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SIMS project
Webpage for the EU-funded diagnostic device project

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Point-of-care devices: the next generation of healthcare
Biosensors used in cheap, diagnostic devices are one of the biggest development areas for electronics in the healthcare sector. +PE.com asked industry experts how this sector was developing

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Organic electronics developed for multi-detection diagnostic device
A new European-funded project is bringing together organic electronics and medical testing to create a multi-detection, single-use device

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