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Diagnostics Evaluation Branch (DEB)

Facilitating marker development and validation of innovative in vitro diagnostics to improve clinical outcomes for people with cancer

A prognostic biomarker can be used to estimate a person's chance of recovery or recurrence.

A predictive biomarker can be used to predict whether a person's cancer will respond to a specific treatment.

Program Directors in the Diagnostics Evaluation Branch (DEB) of the Cancer Diagnosis Program (CDP) stimulate and support research using in vitro diagnostics as prognostic markers to advance tumor classification and predictive markers. This research aims to improve response to therapy. The branch collaborates with other researchers and government agencies to analytically and clinically validate in vitro diagnostics and determine their clinical utility.

Research Areas

  • Developing and validating cancer biomarkers for use in clinical studies
  • Stimulating translation of biomarkers to the clinic
  • Promoting approvability of new biomarkers by the FDA and utility of the biomarkers in a clinical setting
  • Supporting assay standardization to ensure test reliability
  • Advancing progress in areas that are not being addressed

Selected Initiatives

Cooperative Agreements: Assay Validation of High-Quality Markers for Clinical Studies in Cancer

The DEB portfolio includes cooperative agreements (UH2/UH3) that support investigator-initiated research. This research focuses on analytical and clinical validation of biomarkers and assays to be used in NCI-supported trials of cancer treatment, control, or prevention. The primary purpose is to improve the development and validation of molecular diagnostics and prepare assays for use in trials to establish clinical utility. Projects in the UH2 phase are focused on analytical validation, and move to the UH3 phase once the assay is ready for clinical validation. See active projects or all funded projects that have been part of this initiative on NIH RePORTER.

DEB Collaborative Activities with the Cancer Therapy Evaluation Program (CTEP)

Program Directors in DEB conduct reviews of the correlative science aspects in CTEP-sponsored early phase clinical trials (Experimental Therapeutics Clinical Trials Network, ETCTN) and late phase clinical trials (National Clinical Trials Network, NCTN).

DEB Program Directors are also essential members of the DCTD Biomarker Review Committee (BRC) and the National Clinical Laboratory Network (NCLN) Review Committee. They organize and conduct reviews for clinical study proposals to support the development of new drugs within the CTEP portfolio.

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