Companion diagnostics (CDx) are key to delivering personalized medicine in oncology, and increasingly in other conditions as well. In 2015, the Tufts Center for the Study of Drug Development estimated that 73 percent of cancer drugs, and 42 percent of all drugs, in development are paired with a diagnostic test to identify patients who can benefit from them.

However, commercializing CDx products remains a challenge for pharmaceutical companies as it may require touching unfamiliar stakeholders and processes as well as performing a range of incremental activities. Further, pharma and their CDx partners may not always be aware of the technological, regulatory, and educational requirements needed to commercialize products with companion diagnostics, nor are they always resourced and incentivized to address those requirements effectively.

Pharma will need to respond to CDx commercialization challenges in order to minimize test leakage, which we define as the failure of biomarker-eligible patients to receive appropriate targeted therapy. There is evidence that some pharma companies are improving their CDx commercialization through a range of approaches, including partnering to develop new tests, staffing organizations with diagnostics specialists, working more closely with CDx partners on commercialization, and forging commercial partnerships with laboratories and other stakeholders. While this represents a step in the right direction, test leakage remains a significant issue that pharma needs to address; handled correctly, these approaches could in the long run significantly improve pharma commercialization models.

This Executive Insights examines how pharmaceutical companies can address the commercialization challenges of companion diagnostics.

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