Despite major advances in the understanding of tumor biology and the individualized medical needs of cancer patients, there?s a major roadblock to creating personalized cancer medicine. Personalized cancer medicine refers totreatment tailored to a patient’s specific needs, based on genetic or molecular abnormalities found in their tumor. The benefit of this kind of targeted therapy is thatpatients more likely benefit from treatment while doctors avoid treating patients who will not. Tumor biomarker tests help physicians in this process that helps them better predicts treatment success.

However, according to a prestigious group of experts from a number of universities, corporations, insurance and advocacy organizations, the problem is that, unlike drugs or other therapies, cancer biomarker tests are generally undervalued by doctors and patients. The experts report their findings in the July 31, 2013 issue of Science Translational Medicine. In their article, the authors report that inconsistent regulatory rules, inadequate reimbursement and insufficient investment in and underfunded tumor biomarker research has left healthcare professionals in a vicious cycle that prevents development and testing of reliable biomarker tests that could be used to personalize clinical care of patients with cancer.

Right now biomarkers are not valued nearly to the extent that we see with therapeutics.

The authors also note that inconsistent regulatory standards, as well as biased scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility has let to a lack of reliable test.

?Right now biomarkers are not valued nearly to the extent that we see with therapeutics. But if a tumor biomarker test is being used to decide whether a patient should receive a certain treatment, then it is as critical for patient care as a therapeutic agent. A bad test is as dangerous as a bad drug,? noted Daniel F. Hayes, M.D., clinical director of the breast oncology program at the University of MichiganComprehensive Cancer Center and the lead author of the article.

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Genetic or molecular make-up
Tumor biomarker tests look at the genetic or molecular make-up of a tumor to determine whether the cancer is likely to progress, and if so, if it is likely to respond to treatment. If the test is good, it can help doctors decide when a patient can safely skip further therapy, or it can be used to direct which drug might be most likely to help. The result: ?personalized medicine,? which means patients get treatments that benefit them specifically and they avoid treatments ? including their costs and side effects ? that are not likely to make a difference for them.

The regulatory process, the research funding, the reimbursement, even the standards for journal publications for tumor biomarker tests are all meager compared to the robust support for drug development, the authors say.

This creates a vicious cycle in which researchers and drug companies don?t invest in tumor biomarker research, tests are not fully evaluated in clinical trials, and tests with uncertain value in terms of predicting the success of treatment are published. This in turn means that few of these tests are included in evidence-based care guidelines, leaving health care professionals unsure of whether or how to use the test, and third-party payers unsure of how much to pay for them.

A Roadmap for change
In their article, the authors offer recommendations designed to serve as a roadmap to break this vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders. To break the vicious cycle, theyrecommend:

  • Reform regulatory review of tumor biomarker tests;
  • Increase reimbursement for tumor biomarker tests that are proven to help determine which therapies will or are working;
  • Increase investment for tumor biomarker research so it?s comparable to new drug research;
  • Increase the rigor for peer review of tumor biomarker publications;
  • Include only proven biomarker tests in evidence-based care guidelines.

?These recommendations are not about creating more regulation, they are about creating an even playing field that allows tumor biomarker tests to be developed and proven clinically relevant. We want to stimulate innovation yet hold investigators and clinicians to the highest scientific standards ? as we now do for therapeutics,? Hayes explained. ?We need to change the way we value tumor biomarkers in this country.?

For more information:
Hayes DF, Allen J, Compton C, Gustavsen G, Leonard DGB, McCormack R, Newcomer L, et al. Tumor-biomarker diagnostics: Breaking a Vicious Cycle. Sci Transl Med 31 July 2013: Vol. 5, Issue 196, p. 196cm6 Sci. Transl. Med. DOI: 10.1126/scitranslmed.3005950 [Abstract]

Photo:Daniel F. Hayes, M.D. Photo courtesy:University of MichiganComprehensive Cancer Center

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