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FDA Investigating Over-The-Counter Gene Tests

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Katie Decicco-Skinner, a cancer biologist at American University, says the tests' results should be taken with a grain of salt.
Rebecca Sheir
Katie Decicco-Skinner, a cancer biologist at American University, says the tests' results should be taken with a grain of salt.

By Rebecca Sheir

The U.S. Food and Drug Administration says it's looking into a new over-the-counter gene-testing kit to see whether it's accurate and does what it says it will do.

Walgreen's is planning to stock the kits to help people assess their risk for inherited diseases. The drugstore chain says the test does not require FDA clearance, since the manufacturer will be analyzing the results at its lab.

But Beth Peshkin, a genetic counselor at Georgetown University, says even accurate results may not be enough to go on.

"The testing that's being done is a snapshot of what we know right now," she says. "They may be testing for three or four variants, when in fact, it may be hundreds that we need to test for to really predict risk in an accurate way."

Katie Decicco-Skinner, a cancer biologist at American University, says the test also doesn't consider non-genetic factors.

"Diet plays a role, exercise plays a role," she says. "There are a variety of other things that are not going to be picked up by this test."

Decicco-Skinner and Peshkin say the tests could be helpful--for instance, for prospective parents. But they warn against false alarms or false complacency, and urge people to see a professional for the best risk assessment.

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