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Codevelopment of Genome-Based Therapeutics and Companion Diagnostics Insights From an Institute of Medicine Roundtable

Robert T. McCormack, PhD1; Joanne Armstrong, MD, MPH2; Debra Leonard, MD, PhD3
[+] Author Affiliations
1Janssen Diagnostics Oncology Research and Development, Raritan, New Jersey
2Aetna, Sugar Land, Texas
3University of Vermont College of Medicine, Burlington
JAMA. 2014;311(14):1395-1396. doi:10.1001/jama.2014.1508.
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More than 100 therapeutics, mostly for oncology, have biomarker tests recommended in their US Food and Drug Administration (FDA) labels.1 Moreover, a strategy to codevelop and cosubmit to the FDA a diagnostic test (companion diagnostic [CoDx]) that specifically targets a drug to patients predicted to respond has had success recently with vemurafenib, targeting the BRAF V600 mutation in metastatic melanoma, and with crizotinib, targeting the EML4-ALK mutation in non–small cell lung cancer.2 Companion diagnostic tests define the subset of patients who are most likely to benefit from a therapy or who should not receive the therapy because of ineffectiveness or predicted adverse effects.3 Genome-based, targeted therapeutics and codeveloped CoDx tests are the foundation of personalized medicine and have potential for contributing to high-value health care.

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