Walgreens to sell genetic testing kits; FDA investigating

? 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 drug store 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 and Pathway will be given a chance to respond.

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.”

Drug stores already carry DNA paternity tests and gender prediction tests for the home, but genetic tests have been harder to find, typically requiring a visit to the doctor’s office.

The Pathway Genomics test kits, sold under the brand name Insight, pledge to provide information on the risks of getting certain diseases, such as Alzheimer’s or breast cancer. The tests also look at the likelihood of passing health problems on to children, and examine how individuals may react to certain drugs.

But the kits are controversial. Some scientists caution that 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 while selling home kits at drug stores would give more people access to genetic testing, receiving genetic information directly from a manufacturer without input from a doctor “increases the chance for misunderstanding or misinterpretation of results.”

The Insight genetic test kit, priced at $20 to $30, comes with a vial and a shipping envelope. Buyers send a sample of their saliva to a Pathway Genomics laboratory, and receive their results online. The online account needed to view the reports varies from $79 to $179, depending on the type of test requested.