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December 6, 1995

Questions on Genetic Testing Services

JAMA. 1995;274(21):1661-1662. doi:10.1001/jama.1995.03530210015005

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AS SCIENTISTS pinpoint genes that underlie such diseases as cystic fibrosis and breast cancer, commercial and academic laboratories are scrambling to provide genetic testing services aimed at diagnosing gene-related disorders and assessing future disease risk.

The problem with this development, according to a new survey, is that some of the laboratories offering genetic testing are bypassing the admittedly vague regulatory controls or other less formal measures that exist to help assure test validity. Some are also failing to make it clear to physicians and patients that many such procedures are still investigational in nature.

"These findings raise questions of whether the quality of labs providing genetic tests can currently be assured," said Neil A. Holtzman, MD, MPH, of Johns Hopkins Medical School in Baltimore, Md, who reported the results of the survey in Minneapolis, Minn, at the annual meeting of the American Society of Human Genetics (ASHG).

The survey of

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