The committee found limitations in the current system that included lack of common standards for establishing clinical benefit, insufficient communication of information about biomarker tests to patients and clinicians, insufficient oversight and accreditation of testing laboratories, and lack of a structured data collection system.1

As a result, the IOM committee developed 10 goals that, if reached, will enhance the development and use of biomarker tests. These goals form the foundation of the committee’s proposal for a Rapid Learning System for Biomarker Tests for Molecularly Targeted Therapies and include1:

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  1. Establish a common evidentiary standard for clinical utility, both within and outside the context of clinical trials, for all stakeholders
  2. Establish a federal process for regulatory and reimbursement decisions
  3. Improve communication to patients and clinicians about the performance characteristics of biomarker tests
  4. Update and strengthen oversight and enforce laboratory accreditation standards of testing facilities
  5. Ongoing assessment of the clinical utility of biomarker tests
  6. Develop and use electronic health records and other bioinformatics tools to assess data
  7. Develop and maintain a national database of biomarker tests to facilitate rapid learning
  8. Develop equity in access and expertise for effective use of biomarker tests
  9. Enhance specimen handling and documentation
  10. Improve process of recommendation of biomarker tests in clinical practice guidelines

Dr Carethers told Clinical Therapy Advisor that, “This IOM report went further, integrating not only the clinical utility, but also tied it to the regulatory and reimbursement aspects of the test. Thus, the IOM reports are a bit broader in concept, inclusive of all stakeholders.”

Although the report was developed within the context of oncology, Dr Lyman indicated that their goals could be extrapolated to other fields.

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“While oncology is the poster child for this whole area, there are now genetic mutations or biomarkers or targeted therapies in a wide range of diseases outside of oncology,” he said.2


  1. Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine. Graig LAPhillips JKMoses HL, eds. Biomarker tests for molecularly targeted therapies: key to unlocking precision medicine. Washington (DC): National Academies Press (US); 2016. 
  2. Mapes D. This is the future of oncology. Fred Hutch News Service. Published March 4, 2016. Accessed March 17, 2016.