In the wake of the announcement that Walgreens would sell a DNA test over-the-counter on the saliva from Friday on Washington post reports that the drug store stopped its plans. The move comes after the Food and Drug Administration said the test needed its first authorization:
An official FDA told the Post Monday that the test required the authorization of the agency because it implied consumers collect their own DNA. Company officials disputed that, saying the test was exempted from oversight by the FDA because the test was performed in its own laboratory.
But in a letter to Pathway released by the agency on Wednesday night, James L. Woods FDA notified the company that the test "seems to fit the definition of a device" under the Federal law, making therefore subject to the opinion of the agency.
According to the press release builder Pathway Genomics (not currently available on their website, but republished here):
Insight ™ Saliva Collection Kit contains a small collection of saliva kit, simple instructions, and a postage-paid envelope that customers can use to send their saliva sample to the laboratory Pathway Genomics. From there, they simply visit the Pathway website (www.PATHWAY.com) to create their own password-protected secure account and order an individualized Genetic Insight ™ Report for the response of drugs ($ 79), pre-pregnancy planning ($ 179), health Conditions ($ 179) or a combination of three ($ 249). Genetics Insight ™ Reports Pathway offer consumers a convenient and affordable way to learn about their personal genetics.
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