Problem

 Gene expression profile testing for early stage breast cancer was chosen as a promising molecular diagnostic tool with potential for reducing the incidence of unnecessary chemotherapy for a large number of women.

Project History and Current Status  

In 2007, while the CMTP Advisory Group debated a clinically relevant study question, payers began reimbursing for two gene expression profile tests for breast cancer (Mammaprint and Oncotype Dx) rendering a CED-approach to the study increasingly unfeasible. In place of a facilitated-research project on this topic, CMTP contracted with Johns Hopkins University in 2008 to develop an Effectiveness Guidance Document. (EGD) that provides clinical researchers and product developers with guidelines for the design of studies that meet the evidence requirements of health care decision-makers on gene expression profile tests.  The CMTP Advisory Group provides input on the document components and reviews the full EGD to ensure that it meets the information needs of multiple stakeholders.  The final EGD will be made available on the CMTP website in 2009.

Working Party Members