Early Detection Research Network: Conducting Research to Identify, Test and Validate Cancer Biomarkers. Fifth Report

摘要

The essential purpose of early detection of cancer is to reduce mortality and morbidity while minimizing the risks of screening and associated treatment. As molecularly-informed research moves us closer to progressively more specific interventions with less toxicity, the Early Detection Research Network (EDRN) is focused on finding new and improved methods to noninvasively and accurately detect potentially life-threatening cancers at their earliest stages. As genomic knowledge accumulates, general guidelines for cancer screening may be supplanted by more targeted testing methods using validated cancer biomarkers to screen individuals at differing levels of risk. However, the deluge of molecular data increasingly challenges the ability of researchers and medical practitioners to find reliable ways to stratify the many kinds of cancer and degrees of cancer risk. Accordingly, the EDRN laboratories are bridging the critical steps in the process of moving a biomarker from discovery to clinical use by validating both its analytical and clinical performance. Analytical performance measures the reproducibility, precision, and accuracy of the assays. Clinical validation of a biomarker or panel of biomarkers determines its capacity to accurately distinguish patients with cancer from those without, or to detect preclinical cancer. The full range of expertise for the development of early detection biomarkers requires a multidisciplinary effort, and the EDRN was created to integrate the efforts of the necessary spectrum of disciplines.