Abstract

termine whether cancer cells are human epidermal growth factor receptor 2–positive, would undergo more scrutiny. Hogarth explained that such oversight is necessary because under the current system, test manufacturers possess much more information about the tests than do the clinicians or patients using them. In fact, the need to provide clinicians and patients with more and better information about genetic tests is a theme that is emphasized by all groups calling for better standards for molecular genetic testing laboratories. “We strongly favor the provision of useful information to providers who order tests,” Watson said. Additionally, he noted that the ACMG is advocating for more research on the clinical use of genetic tests. Such data are critical to helping ensure that physicians are using genetic tests in ways that improve patient outcomes. “Despite our government having invested several billion dollars in the Human Genome Project, little has been invested in developing an organized system for collecting the clinical validity and utility data,” Watson said.

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