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IOM National Cancer Policy Forum Releases a Report on Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies

The Institute of Medicine National Cancer Policy Forum has released a summary report on a workshop it hosted on November 10, 2014 titled “Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies.” 

This report highlights the numerous challenges raised by workshop participants on the development of biomarker tests, implementation of cancer therapies into the clinic, clinical trial structure and reimbursement issues related to molecular profiling tests. Some of the challenges put forward included the following:

  • Lack of standards and the difficulty in assessing the analytical/clinical validity of biomarker tests.
  • Insufficient or inadequate tissue specimens for effective implementation of molecularly targeted cancer diagnostics and therapies into the clinic.
  • Downstream costs, including the costs of dealing with incidental findings as it pertains to the reimbursement of molecular profiling tests.
  • Identifying patients with rare molecular subtypes of cancer who are likely to respond to experimental targeted treatments for basket or umbrella clinical trials.

The report also summarizes the presentations and discussions held during the workshop and includes a broad range of views, ideas and suggestions from individual participants, some of which include:

  • The need for greater cooperation and sharing of data between corporations and institutions in order to gather evidence that will aid in the determination of clinical validity and utility of biomarker tests.
  • The need for financial resources and testing infrastructure in order to effectively implement targeted therapies into the clinic.
  • The need for more evidence regarding clinical validity and utility of molecular profiling tests in order to facilitate the reimbursement process.
  • Allocating resources towards identifying patients with rare molecular subtypes who could be included into clinical trials. 

ASH is a member of the IOM NCPF, and will continue to monitor this issue. For the full text of the report click here.