Fraunhofer Institute for Toxicology and Experimental MedicineIntroducing mutational profiles and/or gene expression signatures into a biomarker development approach is coupled with translating the clinical outcome-related biomarker into a robust assay applicable to widespread analysis platforms. Via the certified and accredited single-cell laboratory (Link zu Molekulare Diagnostik, B. Polzer), the Fraunhofer ITEM team in Regensburg has access to large sample numbers allowing evaluation of whether a molecular test has sufficient power to actually predict clinical outcome. Moreover, access to a biobank with sufficient quantities of high-quality single-cell samples also allows adaptation of molecular tests to constantly changing technologies.