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FDA Sends Interleukin Genetics, DNA-CardioCheck Untitled Letters

This article as been updated to note three different tests cited in the FDA's letter and to correctly state that Interleukin's deal with NYU focuses on advancing a test for osteoarthritis progression, not PerioPredict.

NEW YORK (GenomeWeb) – The US Food and Drug Administration has issued untitled letters to Interleukin Genetics and DNA-CardioCheck, requesting additional information on their direct-to-consumer tests.

The FDA cites in its letter to Interleukin the firm's PerioPredict Genetic Test, Osteoarthritis Genetic Test, and Weight Management Genetic Test, which are intended to identify individuals with a genetic predisposition for increased risk to periodontal disease, osteoarthritis-related conditions, and obesity-related genotype for weight loss, respectively. 

DNA-CardioCheck offers an eponymous test for genetic markers associated with cardiovascular disease, stroke, deep-vein thrombosis, and thrombophilia.

In letters sent Nov. 4, to Interleukin Genetics, and Nov. 2, to DNA-CardioCheck, the FDA said that the respective tests appeared "to meet the definition of a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act."

The FDA added that it has been unable to identify FDA clearance numbers for either test and requested that each firm either provide the agency with the number or with the reasons it believes that FDA clearance is not required for the respective product.

Interleukin Genetics announced a plan to commercialize a genetic test that identifies people at heightened risk for osteoarthritis progression in July in partnership with NYU School of Medicine. Separately, the firm has been needled by questions about the PerioPredict test's relevance to clinical use.

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