Walgreen’s Won’t Sell At-Home DNA Tests Any Time Soon as FDA Intervenes

Pathway Genomics’ DNA tests allege that from a small saliva sample, they can assess a person’s risk of getting more than 70 diseases. The kits, which cost about $20 via the company’s website, contain a plastic tube to contain saliva, instructions and a postage-paid envelope to send in the spit sample to the company’s laboratory. Originally, Walgreen’s had planned to start selling the kits in their stores starting today. However, after the Food and Drug Administration recently intervened, Walgreen’s changed its mind and is now indefinitely postponing the sale of the kits at stores nationwide.

The FDA contacted the genetic testing company because of concerns that were recently raised by geneticists, who argue that scientific understanding is not sufficient to accurately assess risks for common diseases with a simple commercially-sold test. Even with more advanced testing, scientists still aren’t always sure what genetic markers mean exactly because genomic research is still in the very early stages of development. Specifically, according to Dr. Kenneth Offit, chief of the clinical genetics service at Memorial Sloan-Kettering Cancer Center in New York:

"Many of these markers are not understood, even what genes they are affecting right now. It’s a very, very early stage in this level of genomic research."

Due to the geneticists’ concerns, the FDA warned consumers that “they may be putting themselves at risk if they rely on a test that hasn’t been validated or approved by the FDA”. While these tests aren’t new on the market (they’ve been sold online since September), selling the tests at Walgreen’s would mark the first time the product would be sold at a major retail chain. Furthermore, the FDA has been reviewing online marketing practices of companies like Pathway Genomics and has requested that such companies contact the agency about the legitimacy of claims made on the product websites.

Additionally, while genetic information can be useful, it an also be very confusing—particularly if consumers are collecting their own saliva samples and sending them into various laboratories, which could give conflicting results. What’s worse is that Pathway Genomics advertises their DNA tests as methods of “pre-pregnancy planning”, where consumers can test for genetic mutations and resulting disorders in fetuses such as cystic fibrosis or Tay-Sachs disease. Geneticists are particularly concerned that consumers will use the results of the at-home DNA tests to either stop taking care of themselves because of false reassurance that they he or she is not at risk for a genetic disease. Similarly, geneticists are also concerned that DNA test results will trigger unwarranted worry in consumers because of results that show risk for genetic disease.