Abstract
Abstract The talk will review the real world example of how Pathwork Diagnostics approached both technical and commercial challenges during the development and launch of a new molecular diagnostic. Our technical challenges were to create a mechanism for handling large sets of gene expression data, to accurately answer complex clinical questions and to maintain robust performance levels appropriate for a clinical diagnostic test. Our commercial challenges were centered around the appropriate selection of our regulatory path and market channels, and how to drive adoption and reimbursement. We will discuss the resulting successful launch of the Pathwork ®Tissue of Origin Test and the clinical utility evidence that demonstrates the positive impact of this molecular diagnostic test on patient care and outcome.
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