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FDA Panel Urges Caution on Genetic Test Kits

Advisory Panel Is Wary of Genetic Testing That Is Sold Directly to Consumers

FDA Scrutiny of Genetic Testing Kits

Last year, FDA scrutiny prompted Walgreens to pull back on a decision to sell genetic testing kits from a company called Pathway Genomics.

Ed MacBean, the company’s vice president of product management, acknowledged his company had “treaded into” an uncertain business situation, given the FDA’s move.

Other companies, like 23andMe, offer consumers genetic testing kits directly to consumers over the Internet. The company’s web site promises consumers insight into traits from baldness to muscle performance and the chance to “discover risk factors for 95 diseases” for $199.

The company was founded by Anne Wojcicki, wife of Google co-founder Sergey Brin.

Alberto Guttierez, PhD, director of the FDA’s office of in vitro diagnostics, says the agency would look at tests on a case-by-case basis to decide if they should be available directly to consumers.

Tests for genes that affect prescription drug metabolism are likely to remain restricted since the drugs themselves can only be obtained under a doctor’s care. But other tests helping predict metabolism of certain foods would probably have fewer safety implications and may enjoy easier sales for companies.

“It’s going to depend on the test and what they want to claim and how it’s offered,” he told reporters.

The agency will look at the quality of scientific data connecting a test to the disease it’s supposed to predict and at “whether people can understand it and do something with it or not,” Guttierez says.


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