Delivering Cancer Diagnostics Tools
Executive SummaryPharma is keenly interested in new cancer diagnostics tools, which in many cases are aimed at selecting the best therapy for a specific patient, measuring response to therapy and predicting or more sensitively measuring relapse. These technologies are often the same as those used in pharma's drug development efforts. But deciding with whom and how to ally for the development and distribution of tests is difficult, showing just how uncharted, and bumpy, is the current diagnostics terrain.
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The wealth of knowledge about genomic alterations that drive cancer has produced a variety of targeted therapies, but when presented with a newly diagnosed patient, oncologists are faced with a wide array of molecular tests to determine which drug might be the best. Foundation Medicine Inc. has developed a fully informative genomic profile that sequences DNA extracted from tumor tissue, identifying variations in over 200 genes that are known to be altered in human solid tumor cancers. The test produces a report that highlights “actionable” genomic alterations and links them to approved drugs known to be effective against the cancer’s genetic profile, or to appropriate clinical trials of targeted therapies in development.
With low-cost whole genome sequencing on the horizon, issues around acquiring and assessing large data sets of sequence information are front and center. The value proposition is also shifting, from the means of acquiring data to their interpretation. But finding a sustainable business model around data analysis and clinical services is far from straightforward.