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The Department of Clinical Chemistry and Pharmacology (KLINBIOCHEM) will act as one of three pilot sites. The main task of the pilot sites is to perform the evaluation of the proposed systems’ usability and clinical value. A specialist in internal medicine, Markus Look, who already gained experience in projects directed at personalized medicine including working with preventive gene polymorphism analyses and analysis of biomarker, will join the department for the study.

According to the title of the market validation study - “An integrated high secure cross border platform for preventative healthcare incorporating genetic and lifestyle analysis” – the main objective of the survey will be selection of patients who display early risk factors for cardiovascular disease, e.g. high blood pressure, elevated LDL-cholesterol and/or low HDL-cholesterol, elevation of homocysteine, increased inflammatory and coagulation biomarkers, such as interleukin-6 and hs-CRP, fibrinogen, who are accessible to life style adjustments (exercise, diet, cessation of smoking etc.) and medical intervention.

The pilot site KLINBIOCHEM selected the criterion of obesity for the testing of the consortium’s service. Therefore, a case-control study comparing two groups, non-obese vs. obese individuals with respect to their genetic variation, biomarker and life-style habits, will be performed.

Intended final outcome of the EUROGENE project as a whole is improvement of an individual’s and/or physician’s decision making process regarding methods of intervention through diet, exercise, medication and also by means of early identification of risk constellations on a genetic level. Since integration of genetic data into the physician’s or the individual’s decision making process is a novel issue, the presumptions which will be made on the basis of genomic information have yet to be fully validated in the ongoing worldwide scientific process.

Once properly communicated to the patient, knowledge of putative genetic risk-constellations may eventually motivate the patient to introduce significant life-style changes, compared to what is presently achieved in disease prevention without genetic information.

The assets of the Department of Clinical Chemistry and Pharmacology regarding the project include:

  • Close contact to all medical disciplines present on the university campus and in the region, in order to recruit study participants and to gather information regarding interests of potential stakeholders.

  • Optimum facilities for storage of blood samples for re-analysis and assessment of a wide range of biomarker, such as HDL/LDL-cholesterol homocysteine, B-vitamins, insulin, interleukin 6, hs-CRP, fibrinogen and others. Biomarker levels will be evaluated along with the genetic variants and life style patterns of the participants of the pilot study

As a governmental institution, the department is highly trustworthy with respect to acceptance of genetic testing by the general public. However, an ethics committee’s approval, which is obligatory, will be applied for and the department will not appear as a commercial contractor.

If the survey proves successful in testing the technical capabilities of the system, which is a priority in this phase of the project, further contacts to expand the system could be made with other stakeholders (practitioners and clinics) who are treating and counseling the relevant target groups.

This, however, will also depend on the acceptance of the “tool” of preventive gene analysis by these stakeholders, the society as a whole and most importantly on the pending legislation processes in Germany.  

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2008