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FoundationOne® CDx is based on our analytically and clinically validated comprehensive platform.1 A practical validation strategy to determine accuracy, including sensitivity and specificity, was applied to the prior FoundationOne® platform. Results demonstrated that the platform had a test sensitivity of 95–99% across alteration types and a high specificity with a positive predictive value of more than 99%. Application of the test to 2,221 clinical cases revealed clinically actionable alterations in 76% of tumours, three times the number of actionable alterations detected by existing diagnostic tests.1