Summary of Recommendations to Develop Biomarker-Based Tools for Cancer

Methods, Tools, and Resources Needed to Discover and Develop Biomarkers

  1. Federal agencies should develop an organized, comprehensive approach to biomarker discovery, and foster development of novel technologies.

  2. Industry and other funders should establish international consortia to generate and share precompetitive data on the validation and qualification of biomarkers.

  3. Funders should place a major emphasis on developing quantitative pathway biomarkers to broaden applicability.

  4. Funders should sponsor demonstration projects to develop biomarkers that can predict efficacy and safety in patients for drugs already on the market.

  5. Government agencies and other funders should sustain support for high-quality biorepositories of prospectively collected samples.

Guidelines, Standards, Oversight, and Incentives Needed for Biomarker Development

  1. Government agencies and other stakeholders should develop a transparent process to create well-defined consensus standards and guidelines for biomarker development, validation, qualification, and use.

  2. The Food and Drug Administration (FDA) and industry should work together to facilitate the codevelopment and approval of diagnostic–therapeutic combinations.

  3. The FDA should clearly delineate and standardize its oversight of biomarker tests used in clinical decision making.

  4. The Centers for Medicare & Medicaid Services (CMS) should develop a specialty area for molecular diagnostics under the Clinical Laboratory Improvement Amendments.

Methods and Processes Needed for Clinical Evaluation and Adoption

  1. CMS should revise and modernize its coding and pricing system for diagnostic tests.

  2. CMS, as well as other payers, should develop criteria for conditional coverage of new biomarker tests.

  3. As a component of conditional coverage, establish procedures for high-quality, population-based assessments of efficacy and cost effectiveness of biomarker tests.

SOURCE: IOM (2007a).

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