Guiding principles are provided and discussed on how to inform the physician scientist and
cancer researcher about quality control systems to enable a consistent assessment of the clinical value of
tumor-associated
biomarkers. Next to
cancer research itself, the Receptor and
Biomarker Group of the European Organization for Research and Treatment of
Cancer (RBG-EORTC) advises on methodologies, test kits and test
reagents utilized for
tumor biomarker determination.
Tumor-associated
biomarkers are important and clinically useful tools which can aid the early diagnosis of
cancer, determine prognosis, predict
therapy response, and monitor disease. With regard to clinical use of
tumor-associated bio-markers, quality assessment and quality assurance programs of the RBG-EORTC are crucially important issues. Test
reagents, assays, and procedures for
tumor sample collection and handling should be standardized. Furthermore, standard operating procedures (SOPs) should be developed for each type of
tumor specimen. Assay formats and the quality of the
tumor biomarker assay results have to be monitored by continuous within- and inter-laboratory proficiency testing. With this approach, a major step forward in the knowledge and understanding of the biological role and the clinical utility of
tumor-associated
biomarkers would be anticipated.