This article defines and describes best practices for the academic and business community
to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond …

BACKGROUND. There is wide interest in the use of molecular markers for the early
detection of cancer, the prediction of disease outcome, and the selection of patients for …

BACKGROUND Biomarkers are playing increasingly important roles in the detection and
management of patients with cancer. Despite an enormous number of publications on …

Testing for tumour markers should only be performed if it results in a better patient outcome,
increased quality of life or reduced overall cost of care. Ideally, the clinical value of a tumour …

Disease biomarkers are used widely in medicine. But very few biomarkers are useful for
cancer diagnosis and monitoring. Over the past 15 years, major investments have been …

Background: Although robust discovery-phase platforms have resulted in the generation of
large numbers of candidate cancer biomarkers, a comparable system for subsequent …

Predictive biomarkers are becoming increasingly important tools in drug development and
clinical research. The importance of using both guidelines for specimen acquisition and …

The last three decades have witnessed a rapid advancement and diffusion of technology in
health services. Technological innovations have given health service providers the means to …

Tremendous efforts have been made over the past few decades to discover novel cancer
biomarkers for use in clinical practice. However, a striking discrepancy exists between the …

A workshop sponsored by the National Cancer Institute and the US Food and Drug
Administration addressed past lessons learned and ongoing challenges faced in biomarker …