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:
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
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.