Prof. Neil Holtzman, MD, PhD
Johns Hopkins University
Tuesday, September 25, 2001 - 12:15pm to 1:15pm
William G. Shepard Room, Frederick R. Weisman Art Museum
The current regulatory framework in the United States does not require developers of genetic testing services to collect information on predictive value before they market tests. Nor is the quality of laboratories providing these services adequately assured. Due largely to the work of the federal Task Force on Genetic Testing, which Prof. Holtzman chaired, and the Secretary of Health and Human Services' Advisory Committee on Genetic Testing, policies to promote the safe and effective use of genetic tests are being developed. For many diseases, the availability of predictive genetic tests will occur well in advance of the availability of therapies for the disease. The consequence of this "therapeutic gap" will be far greater if genetic tests reach the clinical market without adequate clinical validation. Thus, for a variety of reasons, genetic testing, particularly for common diseases, may not be as extensive as anticipated.