D1 11:30 T1- Jeffrey Miller, Invivoscribe; Tim Stenzel, Invivoscribe; Mark Levis, Johns Hopkins University

Day 1 Track 1 Session: Internationally Standardized Assays to Monitor Treatment and Residual Disease

The nascent field of Precision Medicine depends on molecular testing to help physicians identify the right treatment for the right patient at the right time. Since clinical test results help define treatment, it follows that a bad test can be every bit as dangerous as a bad drug. Further, regulatory agencies, including the FDA, have expressed an interest and willingness to help pharmaceutical companies accelerate drug approval if molecular tests clearly demonstrate clinical efficacy. As virtually all drug trials depend on the stratification and enrollment of patients drawn from multiple clinical sites, often located around the world, accelerating drug trials depends both on more careful and uniform selection and better monitoring of patients.

This session is designed to provide evidence of the ongoing value of international harmonization and standardization of tests and bioinformatics for patient testing.

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