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Date:  March 29, 2007

Contacts:  Vanee Vines, Senior Media Relations Officer

Michelle Strikowsky, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail <>




U.S. Needs Integrated Approach to Improving Research and Development in Cancer Biomarkers 


WASHINGTON -- Federal agencies and other research funders, academic scientists, and private industry should take a coordinated, comprehensive approach to research and development in cancer biomarkers, a field now hindered by piecemeal and unorganized efforts, says a new report from the Institute of Medicine.


Many scientists have long sought ways to diagnose cancers at an early, curable stage or to develop optimal therapies for individual patients.  To that end, biomarkers – which are biological features, such as proteins or biochemicals, that flag the presence of disease or measure the effects of drug treatments – have been held up as promising tools in cancer care.  But significant challenges, including a patchwork of standards for clinical use of cancer biomarkers and unclear regulatory authority over the field, have slowed progress, the report says.   


Oncology therapies are expensive and typically benefit only a minority of patients.  Tests that could show which drugs would work best for an individual patient would reduce costs and improve health outcomes, the report says.  Currently, only a few cancer biomarkers have been validated to justify their use.  A single federal agency should coordinate and oversee a more organized approach to the discovery of these cancer indicators, as well as the development of novel technologies.


To spur R&D in this area, pharmaceutical and diagnostic companies should join with federal agencies to create international research consortia.  Collaborative efforts to generate and share data and scientific leads could leverage the resources of each partner and benefit the entire field, the report says.  Past efforts, notably the Single Nucleotide Polymorphism (SNP) Consortium, demonstrate how such partnerships can decrease costs for each member and yield information that companies may transform into better diagnostics.


In addition, the National Institutes of Health, National Cancer Institute, and other agencies should sustain support for high-quality repositories to store patients' cell and tissue samples collected in prospective studies.  Such samples would be very useful for discovering and validating new biomarkers.  Measures to ensure patients' privacy and rights while promoting research should govern the repositories, the report adds.


Research sponsors should focus support on projects to develop indicators of cell communication pathways that are involved in many kinds of cancer and other diseases -- so that the resulting biomarkers would have the broadest possible application, the report says.  Efforts to develop biomarkers for particular drugs are riskier investments of resources because the indicators could become obsolete if the drugs failed or therapy guidelines changed.


On the whole, government agencies and other stakeholders should cooperate to create guidelines for the development, validation, and use of biomarkers, the report says.  The number of false results generated by widely used biomarker-based tests for breast cancer underscores the need for uniform standards to validate tests and for greater regulatory oversight of tests once they reach the market.  No federal agency now takes responsibility for ensuring the clinical validity or usefulness of biomarkers. 


The study was sponsored by the Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Food and Drug Administration, Centers for Medicare and Medicaid Services, U.S. Health Resources and Services Administration, American Cancer Society, American Society of Clinical Oncology, C-Change, and UnitedHealth Group.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies.  A committee roster follows.



Copies of Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at  The cost of the report is $42.00 (prepaid) plus shipping charges of $4.50 for the first copy and $.95 for each additional copy.  Reporters may obtain a copy from the Office of News and Public Information (contacts listed above). 



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[ This news release and report are available at ]





Committee on Developing Biomarker-based Tools for Cancer Screening, Diagnosis, and Treatment


Harold L. Moses, M.D. (chair)

Hortense B. Ingram Professor of Molecular Oncology;


Frances Williams Preston Laboratories; and

Professor of Cancer Biology, Medicine, and Pathology

Vanderbilt University School of Medicine

Nashville, Tenn.


David Carbone, M.D., Ph.D.

Professor of Medicine and Cancer Biology

Vanderbilt University Medical Center, and


Experimental Therapeutics Program

Vanderbilt-Ingram Cancer Center

Nashville, Tenn.


Leland H. Hartwell, Ph.D.

President and Director

Fred Hutchinson Cancer Research Center, and

Professor of Genome Sciences

University of Washington School of Medicine



Judith K. Hellerstein, Ph.D.

Associate Professor of Economics and Faculty Associate

Maryland Population Research Center

University of Maryland

College Park


Robert S. McDonough, M.D., J.D.

Medical Director

Clinical Policy Unit

Aetna Inc.

Hartford, Conn.


David R. Parkinson, M.D.

Senior Vice President

Oncology Research and Development

Biogen Idec

San Diego


Edith A. Perez, M.D.

Professor of Medicine

Mayo Medical School

Rochester, Minn., and


Cancer Clinical Study Unit

Mayo Clinic

Jacksonville, Fla.


Scott D. Ramsey, M.D., Ph.D.

Full Member, Translational and Outcomes Research Group

Cancer Prevention Program

Division of Public Health Science

Fred Hutchinson Cancer Center, and

Faculty Member

School of Medicine, School of Pharmacy, and Institute of Public Health Genetics

University of Washington



Charles Sawyers, M.D.


Human Oncology and Pathogenesis Program

Memorial Sloan-Kettering Cancer Center

New York City


Howard Schulman, Ph.D.

Vice President of R&D

Biomarker Discovery Sciences

Pharmaceutical Product Development Inc.

Menlo Park, Calif.


Margaret R. Spitz, M.D., M.P.H.

Chair of Epidemiology

M.D. Anderson Cancer Center

University of Texas






Sharyl J. Nass, Ph.D.

Study Director