Publication

“Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.”

—Margaret Mead, an American cultural anthropologist

Reliable and effective diagnostics are critical to the future of cancer treatment. While important lessons have been learned through the development of single-analyte, single-treatment companion diagnostics, healthcare experts believe that precision medicine in oncology has reached an inflection point and that diagnostic development in particular is not able to match the pace of biomarker discovery. Taking the next meaningful step forward in precision medicine will require stakeholders across the healthcare system to rethink their current models of business and employ new approaches. To address existing challenges and consider multistakeholder approaches to advancing precision medicine in oncology, Tapestry Networks, in partnership with public- and private-sector agencies, has convened the Sustainable Predictive Oncology Therapeutics and Diagnostics (SPOT/Dx) Working Group.

As reflected in its name, SPOT/Dx focuses on predictive diagnostics that are used to help determine whether to administer a therapeutic (as opposed to prognostic or susceptibility tests which serve a different function). SPOT/Dx brings together key thought leaders and decision makers from the public and private sectors, including clinical and policy experts, regulators, third-party payers, patient advocates, and industry leaders. By working together through 2014, the group aims to improve patient outcomes by equipping healthcare leaders with the tools to advance the diagnosis and treatment of cancer, clinical decision making, and the regulatory/reimbursement infrastructure that can support a shift to precision medicine. An additional aim is to identify specific opportunity areas in support of this broader mission, determine what is needed to carry recommendations in these areas forward, and develop pilot plans to test/validate these recommendations.

On December 2–3, 2013, the SPOT/Dx Working Group convened in Washington, DC, for its first meeting. Please see the Appendix for a list of meeting participants. The meeting opened with an ambitious conversation on collaboration and a reminder that a dedicated group of individuals and institutions can indeed change the world. Centered on the theme of collaboration, the launch meeting confirmed aspirations for the group, acknowledged and validated the systemic challenges facing molecular diagnostics and precision medicine in oncology, and identified and prioritized opportunity areas for multistakeholder action through plenary discussion, case study analysis, and small-group breakouts. This document presents a summary of themes from the meeting.