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CDMedics: where are we ?

CDMedics: where are we ?. Situation and future developments MEDICEL Meeting MALTA 08.09.11. CD-MEDICS Overall Objectives. Development of disposable microchip for screening of coeliac disease in a portable/hand-held device carrying out multi-analyte tests

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CDMedics: where are we ?

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  1. CDMedics: where are we ? Situation and future developments MEDICEL MeetingMALTA 08.09.11

  2. CD-MEDICS Overall Objectives • 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. MEDICEL

  3. Parameters • 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 MEDICEL

  4. The core of the system MEDICEL

  5. Serology Flow charts HLA MEDICEL

  6. Serology & HLA Reagents MEDICEL

  7. Same sample, Two Methods MEDICEL

  8. Instrumentation MEDICEL

  9. Starting up: inserting the cartridge MEDICEL

  10. Serology: Analysing Results MEDICEL

  11. HLA: Analysing Results MEDICEL

  12. MEDICEL

  13. CD MEDICS instrument connectivity Hospital Information System Demographics Requests/ Replies Patient’s data Physician’s office CDMEDICS Instrument Patient / Test information MEDICEL

  14. Present development stage • Prototypes of instrumentation: available and tested • Serology: reagents and prototypes tested • HLA: reagents and prototypes tested. MEDICEL

  15. Future steps • 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 MEDICEL

  16. Clinically Relevant Outcome • 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. MEDICEL

  17. Thank you for your attention

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