FDA's recent crack down on genetic tests is the result of aggressive claims companies have made in trying to market their tests to consumers, according to Alberto Gutierrez, director of the agency's Office of In Vitro Diagnostics. In an interview with Newsweek
, Gutierrez said that genetic tests marketed to consumers will require 510(k) clearance or PMA approval, and it all boils down to claims the companies have been making.
In May, FDA objected to San Diego-based Pathway Genomics' attempt to market an OTC genetic test collection kit at Walgreens drug stores because it is outside the boundaries of the regulatory safe harbor for laboratory-developed tests, which are regulated by Centers for Medicare & Medicaid Services. Simply put: “The FDA does not consider distribution of a collection kit that is sold directly to the consumer to be within the boundaries of what is allowed for laboratory developed tests,” an agency spokesman said.
Since then, both Walgreens and Pathway Genomics and some other companies have bailed out of such marketing programs, pending FDA's acquiescence.
Regarding the agency's concern about recent claims, Gutierrez said: “Well, the claims [made by the companies] have changed constantly. The original claims from three years ago were very, very vague.”