NEW YORK (GenomeWeb) – The US Food and Drug Administration has issued an untitled letter to direct-to-consumer genetic testing firm DNA4Life requesting additional information on the company's recently launched Pharmacogenetic Report product.
DNA4Life's product, the FDA asserted in its letter issued last week, is marketed directly to patients as a means to predict how they will respond to more than 120 of the most commonly prescribed medications. As such, the test appears to meet the definition of a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act.
The FDA further stated that it has been unable to identify an FDA clearance number for Pharmacogenetic Report and requested that DNA4Life either provide the agency with this number or with the reasons it believes that FDA clearance is not required for its product.
Mandeville, Florida-based DNA4Life introduced Pharmacogenetic Report last month. The company said that the test assesses the 12 most common genes affecting drug metabolism and response in a patient. This information is then compared with more than 120 of the most commonly prescribed medications across all major therapeutic classes.
Ordering of the test is "physician-integrated," as patients are required to share their results with physicians, the company said. The assay costs approximately $249, the company added.