SACGTSecretary's Advisory Committee on Genetic Testing (US National Institutes of Health)
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In 2001, SACGT decided to curtail their efforts related to risk classification of genetic tests as "irresolvable questions had been raised about the feasibility of categorizing tests for oversight purposes based on a limited set of elements in a simple, linear fashion" (46).
In its July 2000 oversight report, SACGT defines "genetic test" broadly, including both somatic and heritable mutations and concluded that "the adequacy of current oversight of genetic tests was inadequate for ensuring the safety, accuracy, and clinical validity of genetic tests."8 This conclusion was based on "the rapidly evolving nature of genetic tests, their anticipated widespread use, and concerns expressed by the public about their potential for misuse or misinterpretation." SACGT offered 26 recommendations to enhance the current system of oversight for genetic testing.
During these consultations, the SACGT heard from individuals who were concerned about the abuse of genetic information by health insurers and employers, whose fears of genetic discrimination dissuaded them from undergoing genetic tests, and who would consider paying out of pocket for genetic tests to prevent the results from posting onto their medical records.
During consultations with the public SACGT heard from many Americans
The SACGT issued a report on the oversight of genetic tests and recommended that the FDA supervise the development and marketing of these tests to ensure safety and effectiveness.
She has served as a consultant to SACGT and NHRPAC.
The SACGT Report, supra note 3, states: "FDA has stated that it has authority, by law, to regulate such tests, but the agency has elected as a matter of enforcement discretion to not exercise that authority, in part because the number of such tests is estimated to exceed the agency's current review capacity" at 10.
The rules include the recommendations from CLIAC and the Secretary's Advisory Committee on Genetic Testing, or SACGT, at the National Institutes of Health.
Enhancing the oversight of genetic tests: recommendations of the SACGT. oba/sacgt.htm (Accessed March 2003).
Patricia Charache of Johns Hopkins Medical Institutions is a committee member as well as a member of the Secretary's Advisory Committee for Genetic Testing (SACGT).