FDA Investigating Walgreens Genetic-Testing Kits

If you were, well, salivating at the idea of spitting into a test tube at your corner Walgreens and sending off for a list of diseases you’re at risk for, you may have to keep that drool in check for a while. The Food and Drug Administration is investigating the planned test kits, which were due to appear in stores later this month.

Walgreens announced the test kits yesterday, and said that they’d sell for $20. Genetic testing, to be done by San Diego-based Pathway Genomics, would cost anywhere from $79 to $249. But it turns out that neither Walgreens nor Pathway bothered to tell the FDA about their plans, according to the Chicago Tribune.

[T]he U.S. Food and Drug Administration told the Chicago Tribune it is investigating claims made by the San Diego-based company and Walgreens in marketing its genetic test, which has not been approved by U.S. regulators. “We are in the process of investigating this test,” said Alberto Gutierrez, director for the FDA’s office of in-vitro diagnostics. “We weren’t aware of this test previously.”

Walgreens issued the Chicago Tribune a statement on Pathway’s behalf that said the San Diego company is “providing consumers with information about their personal genetic makeup and traits.”

Some medical ethicists have criticized Walgreen’s plans, as consumers will not be required to share the results of any tests with a doctor, and may misinterpret results. Privacy advocates have also expressed wariness about the test kits.

FDA to Investigate Genetic-Test Kits [Chicago Tribune]