Over-the-Counter Genetic Test Needs Authorization, Says FDA

Hot on the heels of an announcement that Walgreens would sell an over-the-counter saliva-based DNA test starting this Friday, The Washington Post reports that the drug store has halted its plans. The move comes after the Food and Drug Administration said the test needed its authorization first:

An FDA official told The Post on Monday that the test required the agency's authorization because it involved consumers collecting their own DNA. Company officials disputed that, saying the test was exempt from FDA oversight because the testing was being done at its own lab.

But in a letter to Pathway released by the agency late Wednesday, the FDA's James L. Woods notified the company that the test "appears to meet the definition of a device" under federal law, therefore making it subject to the agency's review.

According to the press release from manufacturer Pathway Genomics (not currently available at their site, but reposted here):

Insight™ Saliva Collection Kit contains a small saliva collection kit, simple instructions, and a postage-paid envelope that customers can use to send their saliva sample back to the Pathway Genomics laboratory. From there, they simply visit Pathway's web site (www.PATHWAY.com) to create their own secure, password-protected account and order an individualized Genetic Insight™ Report for Drug Response ($79), Pre-Pregnancy Planning ($179), Health Conditions ($179) or a combination of all three ($249). Pathway's Genetics Insight™ Reports offer consumers a convenient and affordable way to learn about their personal genetics.