Biospecimens, biomarkers, and burgeoning data: the imperative for more rigorous research standards.

Knowledge of the altered molecular landscapes in disease offers great promise for developing biomarker-based tests to improve diagnosis and optimize treatment. Progress in biomarker research has been frustratingly slow due to the poor clinical trial design and the lack of standards for specimen collection, biomarker analysis, and data reporting. The ability of high throughput genomics, proteomics, and other 'omics' platforms to profile a large number of analytes in a single assay, together with the pending prospect of rapid expansion of whole exome and whole genome sequencing for clinical use, is increasing the technical and logistical complexity of biomarker validation. Harnessing these new technologies and improved productivity in biomarker validation will depend on adopting systems-based approaches and require major changes in the organization and funding strategies for biomarker research. A systems approach will require new multi-institution collaborations, the integration of diverse technical and clinical activities, greater engagement of industry, and education of regulators, clinicians, and payers about how to use biomarkers for improved patient management and clinical outcomes.

Clinical requests for molecular tests: the 3-step evidence check.

Laboratory tests performed by molecular methods are increasing in volume and complexity at an unprecedented rate. Molecular tests have a broad set of applications, and most recently have been advocated as the mechanism by which providers can further tailor treatments to the individual patient. As the momentum behind molecular testing continues to increase, pathology practices may find themselves unprepared for the new wave of molecular medicine. This special article has been developed in an effort to provide pathologists who have limited molecular training with a simple and quick algorithm for determining whether a requested molecular test is appropriate for a patient. Additional recommendations for a more intensive and proactive review and management of molecular requests also are included. The principles discussed can easily be applied to requests for any test, including those not using molecular methods, which would be sent to an outside reference laboratory. This special article was developed from a Webinar for the College of American Pathologists targeting education for pathologists about the transformation of pathology practice in the new molecular and digital age.