It 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.
