1. Situation and future developments MEDICEL Meeting MALTA 08.09.11

2. 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. MEDICEL2 Malta 2011

3. 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 MEDICEL3 Malta 2011

4. MEDICEL4 Malta 2011

5. MEDICEL5 Malta 2011

6. MEDICEL6 Malta 2011

7. MEDICEL7 Malta 2011

8. MEDICEL8 Malta 2011

9. MEDICEL9 Malta 2011

10. MEDICEL10 Malta 2011

11. MEDICEL11 Malta 2011

12. MEDICEL12 Malta 2011

13. MEDICEL13 Malta 2011 Hospital Information System Physician’s office CDMEDICS Instrument Demographics Requests/ Replies Patient / Test information Patient’s data

14. Prototypes of instrumentation: available and tested Serology: reagents and prototypes tested HLA: reagents and prototypes tested. MEDICEL14 Malta 2011

15. 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 MEDICEL15 Malta 2011

16. 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. 16MEDICEL Malta 2011