IOM Committee Recommends Oversight, Common Evidentiary Standards for Biomarker Tests for Molecularly-targeted Therapies

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Increased oversight, common evidentiary standards, and a structured system for collecting patient data are among the recommendations.
Increased oversight, common evidentiary standards, and a structured system for collecting patient data are among the recommendations.

Increased oversight, common evidentiary standards, and a structured system for collecting patient data are among the recommendations for biomarker tests for molecularly targeted therapy issued by the Institute of Medicine (IOM) and the National Academies of Sciences, Engineering, and Medicine.1

The IOM appointed the Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies to determine how stakeholders—including clinicians, regulators, payors, and test developers—can improve the accuracy and validity of biomarker tests for molecularly targeted therapies, while increasing patients' access to the tests.

“With the rapid increase in the number of tests and drugs, it is essential that we have a rigorous process assessing how good the test is, that the test is associated with clinical outcomes, and that using the test and directed therapies improves clinical outcomes (clinical utility),” Gary H. Lyman, MD, MPH, FASCO, FACP, FRCP(Edin), co-director of the Hutchinson Institute for Cancer Outcomes Research, Cancer Prevention Program, Public Health Sciences and Clinical Research Divisions at Fred Hutchinson Cancer Center, and professor of medicine, public health, and pharmacy at the University of Washington in Seattle, WA, and member of the IOM committee, told Cancer Therapy Advisor.

The report provided recommendations specific to improving the process of developing, validating, and establishing clinical utility, rather than recommendations for the actual implementation of biomarker tests in clinical practice.1

RELATED: ASCO Issues New Guidelines for Early Breast Cancer Biomarkers

“The bottom line is ideal clinical utility and safety of the patient, and aligning the right incentives for improvement and reimbursement, and to continuously learn from the process. This is extremely important as we enter the era of precision medicine,” John M. Carethers, MD, the John G. Searle Professor and Chair of the Department of Internal Medicine and Professor of Human Genetics at the University of Michigan, Ann Arbor, and member of the IOM committee, told Cancer Therapy Advisor.

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