Several organizations submitted comments earlier this year expressing concern that the genetic test registry might allow unverified claims.

Public Meeting Set on Proposed Genetic Test Registry

The Nov. 2 public meeting will begin at 9 a.m. in Washington, D.C. Several organizations submitted comments earlier this year expressing concern that the registry be structured to prevent unverified claims and litigation.

The National Institutes of Health will conduct a three-hour public meeting Nov. 2 to discuss its planned registry of currently available genetic testing. NIH announced last March that it would create such a registry to help patients, caregivers, health professionals, clinical laboratory professionals, payers, and policy makers make sound decisions as more and more genetic tests become available, but the comments in response raise questions about how a registry would be used and possibly misused.

"Although more than 2,000 genetic tests are available, there is no public resource that provides centralized information about the availability and scientific basis of these tests," NIH noted in its meeting announcement. To attend the meeting, register by Oct. 27 at

The Genetic Test Registry (GTR) project will be developed by The National Center for Biotechnology Information, part of the National Library of Medicine at NIH, and is expected to be available in 2011, according to the announcement.

Elizabeth Kearney, MS, CGC, MBA, president of the National Society of Genetic Counselors, submitted comments July 7 in which she asked NIH to consider peer review of submissions for the registry. "The NSGC is concerned that tests that have little or no clinical validity will gain credibility simply by being listed on the GTR," Kearney wrote. "We appreciate the potential debate that could ensue for some tests but we also fear tests that appear on the registry will automatically become valid in the eyes of the public and nongenetics professionals. If formal peer review is not deemed feasible, then the NSGC would recommend creating the ability for external comments by providers and other laboratories."

In comments dated July 29, Helen Darling, president of the National Business Group on Health, agreed with several other commenters in recommending that the registry permit only Clinical Laboratory Improvement Amendments (CLIA) certified labs to participate. "Although not directly relevant to your request and more appropriate for the FDA," she wrote, "we are deeply concerned about direct-to-consumer (DTC) selling of genetic tests. We will express our concerns to the appropriate individuals and agencies but wanted you to know that DTC advertising of genetic tests sends the signal that genetic tests by any company are acceptable and equal in value."

Stephen C. Suffin, M.D., Quest Diagnostics' vice president and chief laboratory officer, urged NIH in his comments to ensure the registry is "designed as a scientific resource rather than as a platform for unverified representations or claims or as a mechanism for companies that wish to gain proprietary information about their competitors' tests."

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