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Federal Oversight Lacking for Genetic Tests, NIH Says

Federal regulation and oversight of genetic tests is inadequate and a growing number of the tests are being marketed with unproven, ambiguous, false or misleading claims, according to the final draft report of the NIH's Secretary's Advisory Committee on Genetics, Health and Society, the New York Times reports.

The 15-member panel examined tests that use cheek swabs, blood samples, biopsies and other tissue samples to analyze DNA, RNA, chromosomes, genes, enzymes or other proteins to detect mutations related to diseases or health.

According to the Times, the tests "can provide information to help prevent, detect and treat hundreds of conditions," such as cancer, heart disease and diabetes. However, according to the panel, people could be harmed if a test provides inaccurate results that lead to risky, unnecessary treatment or denial of treatment that could be beneficial. The panel said that "there is currently no requirement that test providers disclose information to support claims about the accuracy and validity of testing," adding that there is little scientific evidence of the tests' benefits. In addition, the panel noted that FDA "is not currently assessing the clinical validity of most genetic tests," and physicians and patients cannot be sure a test will provide the promised results.

The panel also said that most physicians do not have adequate training and expertise to interpret genetic test results, and many are not aware of the professional guidelines for their use. The panel noted that while professional societies provide their members with up-to-date information, "they cannot keep up with the pace of development of genetic tests." In addition, the panel said many companies are marketing genetic tests directly to consumers, which raises "significant ethical concerns."

Some members of the genetic testing industry are open to federal regulatory standards, but others believe that genetic experts are capable of setting their own regulations, the Times reports. Alan Mertz, president of the trade group American Clinical Laboratory Association, said that excessive regulations and standards could "stifle innovation" in genetics testing (Pear, New York Times, 1/18).

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