Pathway Genomics' Insight test will be on the shelves of about 6,000 Walgreens, reports the Washington Post. This "boldest move yet to bring the power of modern molecular medicine to the mass market" may also me "irresponsible" as it "could give many buyers a dangerous false sense of security or, conversely, needlessly alarm them," the Post says. In addition, the US Food and Drug Administration says it will be looking into whether the test can legally be sold, as FDA has not approved it. "They are making medical claims. We don't know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test," says Alberto Gutierrez, the director of the office of in vitro diagnostics at FDA.
Pathway's chief science officer David Becker says they don't think they need approval. "I think there is some underestimation of the ability of the American public to understand this kind of information," Becker says. "They may not understand the exact specifics, but they do understand that these are propensities."
Our sister publication GenomeWeb Daily News notes that the tests will not be found in Walgreens in New York as the state has stricter rules surrounding direct-to-consumer genetic testing. Pathway does have a license from the state of California, and is CLIA-certified.