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Genetic Tests and FDA

FDA will convene a public meeting next week to hear from companies that make direct-to-consumer genetic tests, before it begins an overhaul of its regulations on genetic diagnostic testing, MIT's Technology Review says. FDA says doctors need help interpreting results from these tests, and that a third party should assess them before they are sold to the general public. "More than 2,000 genetic tests are now available through clinical laboratories," Technology Review's Emily Singer writes. FDA has made moves towards regulation of these tests in recent years, she adds, but the issue gained widespread notice in May when Pathway Genomics said it was going to sell its DTC genetic tests at Walgreens. (Walgreens called off the deal under FDA pressure, as our sister blog The Sample noted.) "The agency says it plans to take a risk-based approach, meaning that tests linked to major medical decisions will be more tightly regulated than those that might predict a minor increase in risk for disease," Singer says.