CVS Caremark Corp. announced it had suspended plans to begin offering the Pathway Genomic kits in August, the Chicago Tribune reported Tuesday. Walgreens had planned to begin selling the kits Friday but announced last week that plan was on hold.
James Wood, director of patient and product safety for the U.S. Food and Drug Administration, said in a letter to the company last week he could not find any evidence the kits had been cleared by the agency.
"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.
The kits would allow buyers to send a saliva sample to Pathway, based in San Diego, for analysis. The company's testing fee would be based on the information the consumer wants.
Pathway says its testing allows buyers to learn whether they are at risk for a range of diseases, including breast cancer and Alzheimer's. But questions have been raised about whether most consumers would be able to interpret the results.