Los Angeles Times

FDA to Investigate Genetic-Test Kits

Chicago Tribune

Walgreens on Tuesday said it will begin selling personal genetic testing kits on Friday, the first major retail chain in the U.S. to offer the home tests.

The Deerfield, Ill.-based drugstore chain has an agreement with Pathway, a startup that offers genetic health and ancestry reports.

But the 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."

The FDA said it will start its investigation of Pathway Genomics, the maker of personal genetic testing kits that are expected to be available in Walgreens later this month.

Gutierrez said FDA officials have been searching the agency's databases and have found no evidence the test has been approved. The FDA said its investigation is in its early stages.

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 scientists caution that the Pathway Genomics home tests can't provide meaningful information. There is no concrete test for Alzheimer's, for example, because researchers still aren't sure what causes the disease.

The National Society of Genetic Counselors warned in a statement Tuesday that receiving genetic information directly from a manufacturer without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."

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