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Evidence-based laboratory medicine in oncology drug development: from biomarkers to diagnostics

Vijay Modur1, Eric Hailman, J C Barrett

  • 1HTG Molecular Diagnostics, Inc., 3430 E. Global Loop, Tucson, AZ 85706, USA. vmodur@htgmolecular.com

Clinical Chemistry
|October 5, 2012
PubMed
Abstract

Insights

Biomarker assessments are crucial for developing targeted cancer therapies. These systematic evaluations, using laboratory medicine principles, generate essential data for informed decisions and can evolve into diagnostic tests.

Area of Science:

  • Oncology
  • Translational Medicine
  • Laboratory Medicine

Background:

  • Targeted therapies offer promise for molecularly defined cancer subsets, transforming oncology drug development.
  • High-quality translational data, generated through biomarkers, is essential for precise and successful cancer targeting.
  • Biomarkers guide critical decisions in drug development, from compound selection to patient safety.

Purpose of the Study:

  • To highlight the indispensable role of systematic biomarker assessments in advancing targeted cancer therapy development.
  • To underscore the importance of applying fundamental laboratory medicine principles in generating reliable biomarker data.
  • To illustrate how successful biomarkers can transition into companion diagnostic tests, expanding laboratory medicine practices.

Main Methods:

  • Utilizing pharmacodynamic assessments for optimal compound and dosage selection.
  • Employing tissue biomarkers, imaging, and mutation analysis for early tumor response and patient selection.
  • Implementing markers of organ injury to monitor toxicity and enhance patient safety.

Main Results:

  • Systematic biomarker assessments provide critical translational data for cancer drug development.
  • Fit-for-purpose assay validation and real-time assessments are key tactics for generating robust biomarker data.
  • Clinically informative biomarkers can mature into companion diagnostic tests, enhancing laboratory medicine.

Conclusions:

  • Systematic biomarker assessments are integral to the clinical development of targeted cancer therapies.
  • Adherence to laboratory medicine principles is vital for generating data that supports informed decision-making.
  • Effective biomarkers can evolve into valuable diagnostic tests, broadening the scope of laboratory medicine.

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