The pathway to clinical use of a cancer biomarker

Abstract

Biomarkers play a key role in the diagnosis and management of patients with cancer, and are important for fulfilling the promise of precision medicine in oncology. However, although numerous biomarkers have been shown to have clinical validity, many have not undergone rigorous testing to demonstrate clinical utility so that they can be appropriately incorporated into clinical care. This review article highlights the characteristics of a good biomarker and the steps required to demonstrate clinical utility, and gives examples of both successful established biomarkers and promising new tissue-based and circulating biomarkers on the horizon.

Keywords:

• Circulating tumor cell
• circulating tumor DNA
• clinical utility
• prospective

Acknowledgements

NLH was supported in part by the A. Alfred Taubman Medical Research Institute.

Disclosure statement

The author reports no conflicts of interest. The author alone is responsible for the content and writing of the paper.