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FDA has questions about DNA testing kit, so Walgreens backs off on selling it

May 13, 2010 | 12:36 pm

Bad news for those of you eager to buy a DNA testing kit at Walgreens: The drug store chain has put off plans to carry the controversial product in its stores.

PathwayIt turns out the Food and Drug Administration has some questions for the kit's manufacturer, San Diego-based Pathway Genomics. According to this story in Thusday's Los Angeles Times, the FDA's deputy director for patient safety and product quality, James Woods, is concerned that his agency hasn't approved the testing kit for sale. Woods sent Pathway Genomics a letter about the situation this week.

"If you do not believe that you are required to obtain FDA clearance or approval," Woods wrote, "please provide us for the basis for the determination."

The Insight Saliva Collection Kit was expected to sell for $20 to $30. Users would deposit some spit and send it off to a testing lab. Then they would go online to order tests that would analyze their DNA for risks for a range of disease, gauge the effectiveness of certain drugs, or check whether they are carriers for dozens of genetic disorders.

In a statement, the company implied that it could sell the products in a bricks-and-mortar store because it has been selling the same kit online for a year. But the company also stressed that it was "continuing discussions with the FDA about the regulation of personal genomic information."

Meanwhile, Walgreens decided it was safer to keep its distance from Pathway and its product "until we have further clarity on this matter," said spokesman Jim Cohn.

-- Karen Kaplan

Photo: This DNA testing kit will not be appearing on Walgreens shelves in the near future. Credit: Business Wire

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Comments (1)

I think it is worth noting that the company who is being investigated for the medical test kit (Pathway Genomics) is different than the company with the paternity kit still sold in Walgreens stores(by Identigene). The debate is not over all genetic tests sold in stores, but in tests that tell someone what their risk of getting a disease or disorder. The paternity test is different in that you are very simply comparing markers in your DNA to the same markers in an "alleged father's" DNA. Statistically simply put, if they match, the probablity the alleged father is the child's father is very high(over 99.9999%, if they don't the the probablity is very very that he is the father. Pathway's test however is saying, again very simply, you have these markers that some people with a certain disease also have so you might get it too. It doesn't take into account age, lifestyle, gender, diet, health, or the literally dozens of other things that can lead to getting that disease.

Paternity relys on none of those things. Just your DNA and the alleged father's DNA.




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