FDA To Seek Oversight Of Consumer Genetic Testing
Though genetic testing is already available to consumers - at costs sometimes in the thousands of dollars - the information provided isn't always supported by evidence and may be misleading, The Seattle Times reports. "Many experts agree that health-related genetic testing isn't ready yet to be introduced to a mass audience. Yet several companies have been marketing tests that purport to assess serious concerns, such as the risk of developing diabetes, with remarkably little oversight."
Now, however, the federal Food and Drug Administration is preparing to enter the fray. The FDA put "five companies on notice that it believes personal genetic tests are medical devices and, as such, subject to regulation
The FDA first signaled a possible shift in direction after another firm, Pathway Genomics, last month moved to sell genetic test kits through Walgreens drugstores. The plan was quickly shelved, but a high-profile congressional committee launched its own investigation" (Graham, 6/17).