Walgreens drug stores canceled plans to sell a genetic testing kit because the FDA hasnt reviewed it.
After Pathway Genomics announced this week that its Insight Saliva Collection Kit would be sold at Walgreens, the FDA told Pathway Genomics that the kit meets the definition of a device and is subject to FDA approval.
Though it’s been discussed on genealogy websites, the test kit isn’t a genetic genealogy test. Instead, it’s meant to assess medical conditions and risk for diseases such as Alzheimers. (Pathway Genomics also sells ancestry testing kits on its website.)
The kit was to cost $20 at Walgreens. Then youd send your sample to Pathway Genomics and pick which tests you want (Drug Response, Pre-pregnancy Planning and other Health Conditions) at a cost of up to $249.
The kit is raising concerns about people getting medical information without input from their doctors. Similar testing is available by mail from companies including 23andMe and DNATraits (part of Family Tree DNA).