Situation and future developments MEDICEL Meeting MALTA 08.09.11

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Situation and future developments

MEDICEL MeetingMALTA 08.09.11

• Development of disposable microchip for screening of coeliac disease in a portable/hand-held device carrying out multi-analyte tests

• Simultaneous detection of coeliac disease associated autoantibodies (DPG and tissue transglutaminase) and HLA-DQ2 and DQ8 genes.

• The device will have embedded communication abilities for result storage and easy follow-up, management and monitoring of the patient’s response to withdrawal of gluten from the diet.

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• Serology– Total IgA, DPG IgG and tTG IgA

• common dilution factor 1:100

• HLA Typing– Alleles

• DQA1*0501 / DQA1*0505

• DQB1*0201 / 0202

• DQB1*0302

– Genotypes• DQ2, DQ8

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Hospital Information System

Hospital Information System

Physician’s office

Physician’s office CDMEDICS

InstrumentCDMEDICS Instrument

Demographics Requests/ Replies

Patient / Test information

Patient’s data

• Prototypes of instrumentation: available and tested

• Serology: reagents and prototypes tested

• HLA: reagents and prototypes tested.

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• End of the project: June 2012• Instrumentation: final prototype and product line defined• Serology: final reagents within Jan 2012• HLA: final reagents within Jan 2012

• Industrial production: 2013

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• Population based screening, and/or screening of high-risk groups and based on the data regarding HLA status, design individually tailored dietary options.

• Monitoring for adherence to the appropriate gluten-free diet either at their GP’s office, or from their own home, with data being communicated directly to their electronic medical record.

• Neonatal screening in risk groups to identify newborns who may develop coeliac disease.

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