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Biomarker identification and clinical validation 

Biomarker identification and clinical validation
Biomarker identification and clinical validation

Richard D. Kennedy

, Manuel Salto-Tellez

, D. Paul Harkin

, and Patrick G. Johnston



Table 11.1 updated with two new biomarkers and references. NRAS added.

MSI testing added as example of predictive biomarker in predictive biomarker section.

Language updated under oncotype DX description.

Updated on 29 March 2019. The previous version of this content can be found here.
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date: 13 July 2020

Most cancer therapy is given in a ‘one size fits all’ manner depending on the anatomical site involved and basic histopathology, with drug dosage calculated from clinical trials using toxicity as an endpoint. An improved understanding of cancer at a molecular level has led clinicians to question how we develop novel drugs and select appropriate patients in the clinic. A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Biomarkers can potentially be used to tailor a patient’s treatment to improve survival and reduce unnecessary toxicity. Though many cancer-related biomarkers have been published in peer-reviewed articles, few have made an impact on patient care because of a failure to demonstrate clinical validity. This chapter explains biomarker discovery and delivery with a view to describing what constitutes a valid biomarker suitable for clinical use.

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