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Date: Friday, Aug. 7, 1998
FOR IMMEDIATE RELEASE 
Contact:  HHS Press Office  (202) 690-6343	

Health and Human Services Secretary Donna Shalala has announced that HHS will create an Advisory Committee on Genetic Testing to help the Department formulate policies on the development, validation and regulation of genetic tests. The Committee will focus especially on tests measuring DNA, the basic chemical component of genes.

"Researchers continue to develop new and exciting genetic tests that can help us treat and prevent disease," Secretary Shalala said. "However, we need to ensure that test results are accurate and medically valid and that this information remains confidential. This new advisory commission creates the mechanism that will help us make sure that patients are protected throughout the process."

The explosion of knowledge about the structures and functions of human genes continues to yield new genetic tests for diseases and susceptibility to diseases. These tests offer not only improved ability to diagnose diseases, but also unprecedented means to estimate future disease risks in healthy individuals, their siblings, and children.

The decision to establish the Secretary's Advisory Committee on Genetic Testing comes in response to the recommendation of two advisory groups commissioned for the Human Genome Project by the National Institutes of Health (NIH) and the Department of Energy (DOE): the Task Force on Genetic Testing and the Joint NIH/DOE Committee to Evaluate the Ethical, Legal, and Social Implications Program of the Human Genome Project.

The Secretary's Advisory Committee on Genetic Testing will address broad, Department-wide policy issues raised by genetic testing. It will have overlapping membership with the Clinical Laboratory Improvement Advisory Committee and the Medical Devices Advisory Committee. The Committee's recommendations will be submitted to the Secretary through the Assistant Secretary for Health, who also will be responsible for coordinating common agenda issues among the three advisory committees. The Secretary hopes to appoint committee members by the end of the year.