a system in which all genomic diagnostic tests are approved through FDA rather than going through the LDT pathway. Sue Siegel, with the venture capital firm Mohr Davidow, said that venture capital funds are currently reluctant to invest in life sciences and health care start-ups, including molecular diagnostics, because of the continued lack of clarity surrounding the regulatory and reimbursement areas. Both speakers called for major changes in the regulation of genomic diagnostic tests to ensure that the field continues to move forward.

A CONSOLIDATED SYSTEM OF REVIEW AND APPROVAL FOR GENOMIC DIAGNOSTIC TESTS

Oncologists overtreat probably 75 percent of their patients, according to Hayes, because they often do not know which patients are going to benefit from which therapies. “We treat everybody in the hopes that we’ll hit the ones that need it and will benefit. I tell my post-docs that luck is not a good strategy in golf or science. It’s nice to have when you get it, but it’d be really nice if we could focus our treatment on patients and not just hope that we get lucky.”

A bad diagnostic test for a tumor biomarker is as harmful as a bad drug, Hayes pointed out. He asked whether physicians would use a drug if they were not sure how it was mixed or what its concentration was, if they did not have clinical data about how the drug might be used, and if they did not have reliable clinical research data to determine how much efficacy it might have. “Of course not, but every day of the week we see patients whose treatment is being altered by tumor biomarkers in the absence of really good data to support that.”

The basic problem is that there has been relatively little consistency regarding which biomarkers have been introduced into clinical practice. Very few cancer biomarkers with demonstrated clinical utility have been introduced over the past 30 years. Even among those tests that have been integrated into practice, their use in certain settings has not always been supported by evidence of benefit, such as the use of prostate-specific antigen (PSA) as a screening test (Andriole et al., 2009), said Hayes. This has helped to create what Hayes has termed a “vicious cycle” in which tumor biomarkers are systematically undervalued (Figure 2-1). This undervaluation has led to limited use of these diagnostics by health care providers and poor reimbursement when a marker has been able to navigate the regulatory environment to be brought to market. Lack of use and reimbursement in turn leads to limited funding for biomarker research because the return on investment is low. The perception that markers have little utility has also led to an environment of lower academic recognition for developing biomarker-based tests. The overall result is reduced ability and incen-



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