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New ways to understand biology as well as increasing interest in personalized treatments requires new capabilities for the assessment of therapy response. The lack of consensus methods and qualification evidence needed for large-scale multicenter trials, and in turn the standardization that allows them, are widely acknowledged to be the limiting factor in the deployment of qualified imaging biomarkers...
Lung cancer is the leading cause of cancer death in the United States. Mortality outcomes have improved only modestly over the past 30 years. There is intense focus on the development of better treatments for lung cancer. Major issues include the cost and time duration of the clinical trials required to establish the utility of a drug so that it can be formally approved by regulatory agencies. In...
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