Qualification – the evidentiary process of linking an assay with biological and clinical endpoints that is dependent on the intended application.
Ras gene – a gene encoding for a signal transduction protein that has been found to cause cancer when the gene is altered (mutated). Agents that block its activity may stop the growth of cancer.
Trastuzumab – see Human epidermal growth factor receptor 2.
Validation – the process of assessing the assay or measurement performance characteristics.
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Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary . Washington, DC: The National Academies Press,
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