Publication

On February 25, 2015, a diverse group of stakeholders convened in Washington, DC for the initial meeting of the Quality Assurance Pilot for Cancer Companion Diagnostics (CDx), or “Quality Pilot” for short. Please see the full meeting summary below for a list of participants. The Quality Pilot’s mission is to bring greater system-wide assurance that the correct patients are selected for targeted cancer therapies regardless of the particular lab or diagnostic test employed in their care. The group hopes to accomplish this goal through the creation and adoption of consensus performance standards that will enable labs to demonstrate desired levels of CDx test performance in a transparent manner. Participants aligned on the need for CDx performance standards, explored the intricacies of the proposed approach, and considered high-level operational questions. The meeting was infused with a strong collaborative spirit and the common understanding that, as a payer put it, “it’s time for the rubber to hit the road.”