Abstract
The term "companion biomarker" means that a particular diagnostic test is
specifically linked to a therapeutic drug either in drug development or in the
clinic. Biomarkers of disease have long played an important role in diagnostic
medicine as evidenced by the intense use of specific clinical laboratory tests
in the diagnosis of disease.
Biomarkers can be used in five very distinct ways in drug development:
1) companion biomarkers can be correlated with biological events during drug
development in order to validate drug targets or to predict drug response;
2) biomarkers can be used as companion diagnostics in drug development to
characterize patient populations in order to better understand the extent to
which new drugs reach intended therapeutic targets can alter proposed
therapeutic pathways and achieve successful clinical outcomes;
3) biomarkers can be used to stratify patient populations for drug response in
primary prevention or disease-modification studies, particularly in specific
clinical areas such as neuron degeneration and cancer;
4) clinically useful biomarkers are becoming increasingly useful to make
proper therapeutic decisions regarding candidate drugs; and
5) clinically useful biomarkers are becoming increasingly required by the FDA
and other outside authorities to make proper regulatory decisions regarding
candidate drugs.
This TriMark Publications report describes new biomarker technology platforms
developed for the analyses of drug targets that are connected to the
effectiveness of therapeutic agents in a clinical setting. The emphasis is on
those companies that are actively developing and marketing new companion
diagnostic tests for performing biomarker tests during drug development, as
opposed to the more routine and clinically accepted companion markers that are
manufactured and marketed by large diagnostic companies for routine clinical
use.
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