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FDA: Gene Tests Need Premarket Approval

[Quotes CGS's Jesse Reynolds]

by Bridget M. KuehnJournal of the American Medical Association
July 14th, 2010

Companies that manufacture or market direct-to-consumer tests must submit their products for premarketing review and approval by the Food and Drug Administration (FDA), according to a series of warning letters sent by the agency in May and June.

The letters indicate a shift in the FDA's approach to the tests, which previously had been marketed to consumers online with little oversight. But letters indicate that the agency considers the tests medical devices that consumers may use to make medical decisions and as such require premarket approval.

"It is important that [the tests] be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations," said Alberto Gutierrez, PhD, of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, in warning letters dated June 10.
"Premarket review allows for an independent and unbiased assessment of a diagnostic test's ability to generate test results that can reliably be used to support good health care decisions."

The tests have garnered renewed public attention in recent weeks. In May, Walgreens, the largest drug store chain in the United States, announced that it planned to sell genetic tests for consumers made by Pathway Genomics Corporation. The manufacturer marketed the tests as offering information to consumers about their risk of developing more than 70 health conditions, information about whether they carried genes for inherited conditions such as Tay-Sachs disease or cystic fibrosis, and information about their potential response to certain drugs, such as warfarin or clopidogrel. But the plan was scuttled by Walgreens after the FDA sent a warning letter to the manufacturer May 10 stating that the tests are medical devices that had not received agency approval.

On June 10, the FDA sent similar warning letters to four companies marketing such tests online and to a manufacturer of a microarray used by two of these companies. In the latest letters, the FDA also notes various reasons why the tests do not qualify as in-house laboratory tests, which the agency previously had declined to regulate.

Jesse Reynolds, a policy analyst at the Center for Genetics and Society, a non-profit organization that has lobbied for greater oversight of the tests, said in a statement that the companies have tried to "have it both ways" by stating that their tests are only for educational or recreational purposes, despite making health-related marketing claims.

"The FDA letters are steps toward protecting consumers and providing clarification for the industry," he said.

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