Translating Tissue Biomarkers into Diagnostic Application – Challenges, Bias, Pitfalls

Authors:

Peter Schirmacher, MD (Germany)

Translation of promising experimentally derived biomarkers into tumour tissue diagnostics is multistep process that is challenged by many obstacles. It is decisive for the successful implementation of the respective targeted therapy but at the same time represents the most neglected part of translational research as well as industrial strategies. Implementation of predictive diagnostics involves preclinical assessment of suited collectives, trial associated diagnostics, roll-out strategies, quality assessment and bedside-bench research concepts. Among the many pitfalls are consideration of rapid, robust, financed and broadly implemented assays, need for intensive industry-academic interaction, international differences in approval conditions, and changes in therapeutic concepts, just to name a few. The situation for HCC is specifically worrisome as it is the only relevant tumour disease, which does not require tumour tissue acquisition before initiation of specific antineoplastic therapy and as no targeted therapy is approved for HCC so far, leaving an unpaved road ahead. HCC threatens to lose further ground in competition with other major tumour diseases, already offering multiple targeted concepts (e.g. breast, colon, lung cancer). Aim of the presentation is to delineate the challenges ahead and strategies to implement predictive diagnostics for targeted HCC therapy in the most reliable and rapid manner.