By Bruce Japsen and Sandra M. Jones | The U.S. Food and Drug Administration has given San Diego-based Pathway Genomics 15 days to respond to the agency’s request for information regarding its controversial genetic home test kit.

In a letter released this evening, FDA Deputy Director for Patient Safety and Product Quality James Woods said the agency 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 their saliva to a Pathway Genomics laboratory, then receive their genetic health report online for a fee.

“If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us for the basis for the determination,” Woods said in his letter to Pathway Genomics dated May 10.

Pathway is scheduled to start selling its genetic home test kit at Walgreens drugstores May 14 and CVS stores in August. The home tests claim to 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.

Pathway officials have said that they believe the test is in compliance federal regulations.

“Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines,” Pathway said in a statement issued tonight in response to the FDA’s inquiry. “Our laboratory is federally CLIA-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.”