Ed. Note: See Commentary, May 11, on this topic to get the full story.

The FDA did not know about this test. The company’s position was that the product did not require an FDA approval.

The story yesterday said that these kits would go on sale at 6000-plus Walgreen’s stores Friday. This Los Angeles Times story says the kits now are expected to be available later this month.

The Los Angeles Times

…”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.” (Emphasis added)

“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.”

Source: Los Angeles Times, May 12, 2010