Working group: Personalized medicine
The Personalized Medicine working group has set itself the goal of shedding light on the actual core of precision medicine: targeted diagnostics. Personalized medicine is currently associated primarily with pharmaceutical progress and drug innovations. However, it is inconceivable without the upstream precise in-vitro diagnostics of specific biomarkers.
The identification and validation of suitable biomarkers is the basis for the increased use of personalized medicine. IVD manufacturers focus on biomarkers and use them for highly specific qualitative and quantitative analyses. A wide variety of technologies - mostly at the molecular genetic level - are used here and can, for example, characterize tumour cells in such detail that doctors can apply a tailored therapy. This improves the risk-benefit decision before choosing a therapy and means greater therapeutic success for patients with better side effect management.
The committee's priorities are
Creating awareness for diagnostics in precision medicine
The importance of laboratory diagnostics for the beneficial use of personalized medicine is not limited to the important function of companion diagnostics (CDx). It also covers a wide range of applications in diagnosis, therapy monitoring, prognostic and predictive information and risk analysis in the case of genetic predispositions. The indications addressed range from oncological diseases to autoimmune diseases and infectious diseases. The working group also exchanges information with the pharmaceutical industry.
Advice on the Rili-BÄK
Chapter B 5 "Molecular genetic and cytogenetic laboratory medical examinations" covers the state-of-the-art technologies of next generation sequencing, non-invasive prenatal diagnostics, molecular genetic examinations of circulating tumor DNA and hemato-oncological tumor markers as well as classic cytogenetics. Members of the VDGH's Personalized Medicine working group are part of the Rili-BÄK specialist group D 5 and work together with other stakeholders to develop the quality assurance requirements.
GenomDE
The VDGH welcomes the genome sequencing pilot project in accordance with Section 64e SGB V, which was introduced into healthcare for rare and oncological diseases on April 1, 2024. On the one hand, this will enable patients to benefit from state-of-the-art genomic medicine and receive needs-based treatment. On the other hand, high-quality genome data can be developed and made accessible in Germany, making Germany more competitive and attractive internationally as a life science and diagnostics location. The working group is committed to the further development and consolidation of the currently limited medical services.

