Edward R.B. McCabe, MD, PhD
Secretary's Advisory Committee on Genetic Testing
National Institutes of Health
6000 Executive Blvd., Suite 302
Bethesda, Maryland 20892

Dear Chairman McCabe:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on your preliminary recommendations to David Satcher, MD, Assistant Secretary for Health, and Surgeon General, regarding federal oversight of genetic testing. In general, we support the flexibility outlined in the committee's approach and the continued reliance on the existing federal regulatory framework.

AACC is further encouraged by your efforts to involve the health care community in the decision-making process. We believe it is essential that all affected parties-consumers, government agencies, professional societies and industry-work together to ensure that the final recommendations provide adequate patient protections, while not hindering the development of new tests for diagnosing and treating disease.

Our Association supports a number of the recommendations outlined by the committee, including:

The passage of federal legislation to prohibit health insurance and employment discrimination on the basis of genetic information;

The creation of a consortium of relevant government agencies, industry and professional societies to gather and share genetic testing information;

Changing CLIA'88 to address specific concerns about genetic testing;

Requiring that health care professionals obtain written informed consent from patients prior to performing a predictive genetic test (We recommend that the ordering provider be responsible for obtaining patient approval);

Recognizing the role of professional societies in developing guidelines for genetic research and testing; and

Focusing FDA oversight on predictive genetic tests, which have not been proven safe and for which there is no effective intervention available.

AACC suggests SACGT expand this last point by explicitly recommending that the FDA include representatives from the biotechnology and laboratory communities in future deliberations regarding which tests receive high and low scrutiny and how the process is structured. We share the committee's assessment that overly prescriptive requirements could delay and discourage the introduction of new tests. Adequate federal funding and an ongoing dialogue between the regulators and affected parties are necessary to ensure that appropriate patient care is not hindered.

The panel also recommends that an Institutional Review Board (IRB) review all research protocols for genetic tests in which individually identifiable human subjects or samples are used, regardless of the funding sources. AACC recommends that language, such as the following be inserted in this section: "(1) that investigators conducting genetic research using archived, anonymous samples do not need to obtain informed consent; and (2) that laboratories can maintain a specimen for clinical research once the requested test is performed, as long as patient identifiers are removed." The use of anonymous samples is vital to ensuring the quality of laboratory testing, as well as conducting research into new and improved test development. This language should eliminate future confusion over when informed consent is required and when it is not.

Finally, AACC is concerned that the SACGT is recommending that new federal legislation be enacted to protect the privacy of genetic information in medical records. Although we agree that such data should be protected, we believe such protections should cover all patient data. Last year, the Department of Health and Human Services issued a proposed federal rule, which would ensure the confidentiality of patient medical records, including genetic testing results. We recommend that SACGT support improving those standards, rather than enacting new, separate protections for genetic data.

By way of background, AACC is the principal association of professional laboratory scientists--including MDs, PhDs and medical technologists. AACC's members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and to help maintain high professional standards.

If you have any questions or we may be of any assistance, please call me at (919) 684-8724 or Vince Stine, Director, Government Affairs, at (202) 835-8721.



Frank A. Sedor, PhD President

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