Fresh off sending stern letters to five consumer-genomics companies indicating that, as currently marketed, the companies’ tests will require clearance by the FDA, Alberto Gutierrez—the agency’s director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health—spoke to NEWSWEEK. Among the revelations: Pathway Genomics, the company that started the controversy by planning to sell its test in drugstores, will be withdrawing from the direct-to-consumer market. Gutierrez also clarified the agency’s reasoning and timing. Excerpts:

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