Clinical Laboratories


Guest author of this entry: Dr. Hanns-Georg Klein


Personalized medicine relies on knowledge about the specific genetic and physiological conditions of patient groups or even individual patients. Naturally, all these sophisticated test have to be carried out by somebody sufficiently qualified for the job. These are the clinical laboratories, which operate either as part of a hospital or on their own respectively in networks of laboratories. One member of our board of directors, Dr. Hanns-Georg Klein runs such a laboratory himself. Of course, he is far better qualified to describe this partner in personalized medicine that I ever could. Therefore, I am more than happy that he wrote an entry himself, which I would like to present in translation in the following.


How is this group defined?


Clinical laboratories can only carry out all tests in larger networks. However, individual tests are carried out in a decentralised mode of operation usually lacking data integration and overarching interpretation of the findings. Smaller facilities - such as ours - attempt to master projects of interdisciplinary and holistic laboratory diagnostics ranging from genetics all the way to morphology. 


What are the major roles of this group in personalized medicine?


“Precision Diagnostics” or Companion Diagnostics” as part of personalized medicine are so far only carried out selectively in specialised departments of laboratories or laboratory networks. High costs often prevent a holistic approach. The primary goal is not serial standardised work but a variety of diagnostic views on an individual basis. 


Fig 26: Clinical laboratories - diagnostics


What is the major impact of this group on the development of personalized medicine?


Since increasing individualised therapy necessitates also refined individual diagnostics, clinical laboratories have a high potential of influence on the development of personalised medicine. This also remains true against the background of cost-efficiency: An innovative cancer or HCV treatment can cost 50,000 to 150,000 € per year. Our health care system is willing to bear these costs in order to save on the cost of inpatients. However, in such cases the system needs to be prepared to also accept 10% - 20% of the therapy costs as additional costs for “precision diagnostics” including therapy monitoring. This ensures that expensive therapies are actually applied to those patients that will profit from the treatment. 


With whom has this group the most important interactions?


The major partners are medical directors of large laboratories, but also the pharma and diagnostics industry. It became common sense that all the new compounds, in part developed based on genome research, will increase therapy costs beyond reason. “Precision diagnostics” will restrict such treatment to smaller patient groups. “One drug fits all” is no longer true for new generations of drugs. Unfortunately, cost-saving strategies of huge umbrella organisations often curb the possibilities of clinical laboratories. Germany is among the lowest clinical laboratory costs in international comparisons. This does no leave much room for innovative diagnostic procedures, which often original from smaller laboratories and not from industry. 


What is required of this group to further the development and application of personalized medicine?


To achieve some impact that will further also the cause of patients a centralised representation will be required. This should include public relations, medical specialists from laboratories, pathology, human genetics, microbiology, virology and transfusion medicine. Such an umbrella organisation would also have the political clout to make itself heard. Unfortunately, different associations of MDs disagree as soon as subject-specific budgets or - in plain English -  money is the issue. A common stand on politics and public relations between professional associations and institutions has not yet been reached, preventing an unified appearance. It would be important to start with education: two years of joint education for medical specialists for all these groups of MDs followed by a three-year specialisation phase. Corresponding changes could be introduced into the organisation of congresses and symposia: e.g. a joint meeting every two years of all groups involved. The diagnostic industry is represented by a powerful umbrella organisation (association of diagnostic industry, VDGH). Unfortunately, this association focuses on its own agenda. 


What’s coming up next?


Next week is about the partner, without whom there would be no new drugs, the pharmaceutical industry.

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