Deerfield-based Walgreen Co. had planned to begin stocking thousands of stores nationwide with the Pathway Genomic home test kit on Friday. Walgreens' decision was announced after the FDA released an enforcement letter sent to San Diego-based Pathway Genomics, giving it 15 days to respond to the agency's request for information regarding its controversial genetic home test kit.
In a letter dated Monday and released Wednesday, FDA Deputy Director for Patient Safety and Product Quality James Woods said the FDA has been "unable to identify any Food and Drug Administration clearance or approval number" for the product.
The kit, sold under the brand name Insight, comes with a vial and a shipping envelope. Buyers send a sample of saliva to a Pathway Genomics laboratory and receive a genetic health report online.
"If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us the basis for the determination," Wood said in his letter to Pathway Genomics.
Walgreens drugstores were slated to be the first to sell the genetic home test kit, followed by CVS stores in August. The home tests say they assess the risk of dozens of health conditions, including Alzheimer's disease, breast cancer and heart disease. But some scientists and physicians worry consumers will misuse or misunderstand the results of the tests. The kit was the subject of an article in Wednesday's Tribune.
Pathway officials have said they believe the test is in compliance with federal regulations. They said the kits were not medical devices and were not intended for use in diagnoses, but provide information to people to make lifestyle choices.
"Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines," Pathway said in a statement issued Wednesday in response to the FDA's inquiry. "Our laboratory is federally (Clinical Laboratory Improvement Amendments) certified and state-licensed. We have provided the same personal genetic report to customers for the past year, and are continuing discussions with the FDA about the regulation of personal genomic information."
CVS officials could not be reached for comment.