By Bruce Japsen | CVS
Caremark Corp. will join rival Walgreens in holding off on carrying
genetic test kits in its stores after the U.S. Food and Drug
Administration last week began an investigation of the supplier of the
product. 

Deerfield-based Walgreen Co. had planned to be the first to sell the
Pathway Genomic home test kit on Friday but last Wednesday reversed its
decision to carry the kits. Now, CVS confirms it will hold off on its
plans to begin selling the kits in August.

The moves by the drugstore giants comes after FDA last week released an enforcement letter sent to San Diego-based Pathway Genomics, giving it until the middle of next week to respond to the agency’s request for information regarding its controversial genetic home test kit.

“We are not moving forward until we understand the outcome of the suppliers’ discussions with the FDA,” said CVS spokesman Michael DeAngelis. It was originally intended to launch in August. Those plans are on hold pending the outcome of the FDA’s investigation into the product.”

In a letter dated May 10, 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 Insight, comes with a vial and a shipping envelope. Buyers send a sample of saliva to a Pathway 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 a letter to Pathway Genomics.

The tests say they assess the risk of dozens of health conditions, including Alzheimer’s disease, breast cancer and heart disease. But some scientists worry consumers will misuse or misunderstand the results. The kit was the subject of an article in last 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 to the Tribune last week.

CVS spokesman DeAngelis said company executives were “continuing to learn more about these products and how they can and should be used.”

“We will follow the FDA discussions closely and make a final decision on whether to carry this product after their questions about the test kits are resolved,” DeAngelis said.