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Walgreens, which operates 7,500 retail outlets across the country, is holding off on stocking the tests because of concerns expressed by the Food and Drug Administration in an open letter to the company that makes the product.
On Tuesday, Pathway Genomics, a San Diego-based start-up that already sells genetic tests online, announced that the product, called Insight, would be available at Walgreens locations starting May 14.
Pathway Genomics
Pathway Geneomics' genetic testing kits "have not been proven safe, effective or accurate," a Food and Drug Administration spokeswoman said.
FDA officials quickly questioned the legality of the move. Insight hasn't been tested or approved by the regulatory agency.
"These kits have not been proven safe, effective or accurate, and patients could be making medical decisions based on data from a test that hasn't been validated by the FDA," spokeswoman Erica Jefferson said in a statement Wednesday.
Now, Walgreens says it will "postpone" selling the product "until we have further clarity on this matter."
The incident highlights a gap in how the FDA regulates such products, which have yet to be classified either as simple "consumer information," which wouldn't require agency oversight, or "medical devices," which would. For years, companies like 23andMe and Navigenics have been selling similar tests online, without FDA approval.
But the agency seems troubled by the possibility that retail sales could mean more widespread consumer exposure to the tests, which experts warn are easy to misinterpret and could prompt life-changing decisions.
"It is reckless," Hank Greely, director of Stanford University's Center for Law and the Biosciences, told The Washington Post earlier this week. "Information is powerful, but misunderstood information can be powerfully bad."
Pathway's retail product would include a saliva swab, return envelope and informational booklet. After sending the swab to the company's lab, a customer could pay for various analysis packages. The test is designed to evaluate the risk for developing diseases like Alzheimer's, breast cancer and multiple sclerosis. Customers can also be screened for potential pregnancy risks and their sensitivity to dozens of substances and medications.
The product is slated to be priced at $20, and different packages of DNA analyses cost between $79 and $179. For the test and all three result packages, a customer would pay $279.
The FDA's warning letter to Pathway gives the company 15 days to explain itself.
"We give them a chance to respond and tell us why do you think that this is, in fact, actually a legal product," Dr. Alberto Gutierrez, the FDA's director of diagnostic testing, told The Associated Press.
More useful, however, might be a simple doctor's visit. Most experts argue that DNA tests like Insight are based on flimsy data and that a comprehensive medical history is still a superior predictive tool.
