The promise of personalized medicine, says University of Vermont (UVM) molecular pathologist Debra Leonard, M.D., Ph.D., is the ability to tailor therapy based on markers in the patient's genome and, in the case of cancer, in the cancer's genome. Making this determination depends on not one, but several genetic tests, but the system guiding the development of those tests is complex, and plagued with challenges.
In a February 12, 2014 Online First Journal of the American Medical Association "Viewpoint" article, Leonard and colleagues address this issue in conjunction with the concurrent release of an Institute of Medicine (IOM) Workshop Summary Report on "Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests." A professor and chair of pathology at UVM and Fletcher Allen Health Care, Leonard serves as a representative of the American College of Pathology on the IOM's committee on Translating Genomic-Based Research for Health, which organized the workshop and authored the report.
"Whenever a drug is developed that will target a pathway underlying disease, you need a test that says the patient will benefit," explains Leonard. "The development of companion diagnostic tests to determine if a patient will respond to a specific drug is very complex and needs to be changed, but will require changes from many stakeholders, including test developers, pharmaceutical companies, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and other payers."
The concept of what is called the FDA's "Companion Diagnostic Pathway," explains Leonard, allows for assessment of the test to predict a drug's benefit, within the same clinical drug trial to assess the new drug's effectiveness as a treatment. Cancer specialists are the primary users of these types of drugs and tests.
In their "Viewpoint" article, Leonard and colleagues Robert McCormack, Ph.D., and Joanne Armstrong, M.D., M.P.H., who rep
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University of Vermont