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Plastic diagnostic device prepared for European medical accreditation

Dan Rogers - 29 Mar 2010

A disposable lab-on-a-chip device developed at the German Fraunhofer Institute is being prepared for medical diagnostic applications by getting Europe-wide accreditation.

The device has been prepared by the Fraunhofer Institute'To get accreditation, we will need 12-18 months,' says Eva Ehrentreich, developer of the diagnostic device at Fraunhofer's Institute for Biomedical Engineering.

'The device should then be able to immediately enter the marketplace. We are looking for a partner for this.'

A working prototype has been created and the accreditation process for use in healthcare will now ensure that the tests are accurate, repeatable and that materials are stable.


Uses

The lab-on-a-chip consists of a microarray of sensors integrated into a polymer platform, and can also be used for environmental, water and food testing.

However, first applications will be in the medical field, says Ehrentreich.

'The first applications will be, for instance, for fertility. If a woman wants to have a baby, the device can be used to look for all the hormones associated with this.

'Another early application will be for doping substances.'

The medical tests could provide quick results that can be interpreted without the need for a doctor, via a simple display.

Ehrentreich says: 'The results can be very easily displayed, depending on the user's needs: a doctor needs units like milligrams per millilitre, while agricultural users might need grams per litre.

'A diagnostic device could provide a simple reading, so that no doctor is needed for the first step of diagnosis.'

This is an area that is expected to develop in the near future, driven by the production of cheap organic electronics for point-of-care products.


Cooperation

The disposable cartridge, presented at a recent trade show in Germany in March, has already gained commercial interest from clinical laboratories and agricultural companies in Europe. The device is being adapted for specific applications for these areas, says Ehrentreich.

'They wish to look at the parameters for the device and to measure and test them in these areas,' she explains.

However, Fraunhofer is hoping to find a partner in the medical field with the manufacturing capacity to adopt its technology and scale up.

Ehrentreich remarks: 'This device could be transferred to manufacturing - all the production, filling and preparing of the cartridges can be done in one workflow.

'We need to go into partnership as Fraunhofer is not able to make commercial facilities, but we are open to development for this device.'

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