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Genomic biomarkers for patient selection and stratification: the cancer paradigm
1Molecular & Applied Biosciences, School of Life Sciences, University of Westminster, London, W1W 6UW, UK. s.moschos@westminster.ac.uk
Abstract:
The revolution in disease diagnosis and treatment promised on the completion of the human genome project over a decade ago has materialized in the form of unified drug and biomarker discovery and development pipelines. This strategic shift has been principally catalyzed through success stories in the field of oncology, ushering in the era of personalized medicine. Thus, a number of molecular targets have also been demonstrated to be reliable markers for selecting patients wherein treatment can be efficacious. Perhaps more importantly, however, the late adoption of biomarker strategies has also rescued drug candidates from complete late-stage failure. This review examines the historical lessons of key challenges in translating biomarker assay information into strategic and clinically actionable decisions and assesses the impact of personalized genome sequencing in the future of companion diagnostic development and commercialization.
Insights
Personalized medicine, driven by the human genome project, unifies drug and biomarker discovery. Biomarker strategies are crucial for effective cancer treatment and preventing late-stage drug failures.
Area of Science:
- Biomedical Science
- Genomics
- Translational Medicine
Background:
- The human genome project catalyzed advancements in disease diagnosis and treatment.
- Oncology has pioneered personalized medicine through targeted therapies and biomarker identification.
Purpose of the Study:
- To review challenges in translating biomarker assay information into clinical decisions.
- To assess the impact of personalized genome sequencing on companion diagnostics.
Main Methods:
- Historical review of biomarker strategies.
- Analysis of case studies in oncology.
- Assessment of personalized genome sequencing's role.
Main Results:
- Biomarker strategies have improved patient selection for targeted therapies.
- Biomarkers have rescued drugs from late-stage failure.
- Personalized medicine is transforming drug development pipelines.
Conclusions:
- Overcoming challenges in biomarker translation is key for clinical actionability.
- Personalized genome sequencing will significantly impact companion diagnostic development and commercialization.
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