Walgreen has reportedly planned to sell consumers a genetic testing kit to help them assess their risk for certain inherited diseases.

Media outlets reported that the Food and Drug Administration Wednesday released a May 10 letter addressed to the manufacturer of the genetic testing kit, Pathway Genomics Corp, asking for any proof that the selling of the product has been sanctioned by the agency.

Pathway argued that the personal genetic testing kit is not a diagnostic tool nor a treatment meaning that it is not a medical product that needs to be approved by the FDA for sale.

The complete genetic test based on saliva samples collected using the kit would cost anywhere between $79 and $249, Reuters reported. 

"Many direct-to-consumer genetic testing companies are not testing individuals for disease -- they are testing for the propensity of developing disease conditions," Alan Mertz, president of ACLA, was quoted as saying in a statement.

But James Woods, the FDA official who signed the letter, was quoted as saying "The Genetic Health Report appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act."

Walgreen has now decided to delay selling the genetic testing kit because of the FDA objection.

David Liu