Preanalytic considerations for molecular genomic analyses of tissue

Abstract

Progress in the era of molecular characterization of patients, diseases, and drugs, relies on access to clinical biospecimens characteristic of the general population and of patients with specific disease states to identify predictive and prognostic biomarkers for individualized therapeutic planning. Biospecimens properly consented for clinical research can be difficult to obtain and often are quite limited in volume and mass, making it incumbent on clinical investigators to use these resources effectively to maximize the learning that comes from their analysis. This includes careful documentation of the specimens themselves along with preservation methods and storage planning to support the study objectives. In addition, careful experimental planning focused on the molecules that will be analyzed and commitment to assuring laboratory processes and methods have been fully developed and pre-tested using nonessential, representative biospecimens as surrogates for the intended study specimens are necessary. Following these steps will result in high yields of the best quality data and will ensure interpretable results that will contribute to advancing knowledge of disease states and applicable therapeutic options.