The Rocky Road to Useful Cancer Biomarkers

Biomarkers may be the future of cancer care, allowing earlier diagnosis and more efficient and effective treatment. Certainly, expectations for biomarkers are high, a result of the mapping of the human genome and the development of fast gene and protein analysis technology, as well as promising research reports. But the potential of biomarkers has been harder to realize than expected. Close examination has disproved some promising new biomarkers—specific molecules in the body, such as genes and proteins, that indicate disease—and other biomarkers have ultimately held limited clinical value. Mistakes have also occurred in some biomarker tests used to determine who receives targeted cancer treatments.

“There are technical challenges associated with the validation and qualification of potential cancer markers and challenges associated with developing, evaluating, and incorporating the screening and diagnostic tests that make use of those markers not in clinical practice,” said Hal Moses, MD, chair of the Institute of Medicine's National Cancer Policy Forum and director emeritus of the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. “However, successful development of cost-effective tests could have a profound impact on the way cancer is detected, diagnosed, and treated.”

New biomarkers hold promise for many diseases. Cancer, perhaps because it is responsible for so many deaths, has received much of the attention. Scientists, policymakers, and industry representatives gathered recently for an Institute of Medicine workshop focused on finding solutions to problems in current cancer biomarker research, development, and clinical use. They discussed reasons behind problems and ways to avoid these problems in the future.