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FDA to look at commercial genetic tests
WASHINGTON, Commercial genetic testing services need more stringent control and policing by the federal government over their services and claims, experts say.
Few of the tests or the companies offering them have undergone stringent scientific validation, and results from questionable tests can be unnecessarily alarming, The Washing Post reported Saturday.
"It's come to the point where really there's a need for some oversight," Alberto Gutierrez, who heads the Food and Drug Administration's Office of In Vitro Diagnostics, said.
The agency will convene a public hearing next week to consider what regulatory role it should play.
Companies offer tests claiming to inform people of things from what foods they should eat to live longer and what cosmetics they should use to whether they are at genetic risk for cancer, Alzheimer's and other ailments, the Post said.
Critics say many of the claims are unscientific, give results too complicated for people to understand without medical help or are just plain wrong.
But others say more federal oversight will make the tests too expensive and hard to get.
"If you have things completely unregulated, then you have a Wild West of commercial interests around medical information," Robert C. Green, director of Boston University's Center for Translational Genomics and Health Outcomes, said. "If you over-regulate, you run the risk of stifling innovation in a very dynamic industry."
WASHINGTON, Commercial genetic testing services need more stringent control and policing by the federal government over their services and claims, experts say.
Few of the tests or the companies offering them have undergone stringent scientific validation, and results from questionable tests can be unnecessarily alarming, The Washing Post reported Saturday.
"It's come to the point where really there's a need for some oversight," Alberto Gutierrez, who heads the Food and Drug Administration's Office of In Vitro Diagnostics, said.
The agency will convene a public hearing next week to consider what regulatory role it should play.
Companies offer tests claiming to inform people of things from what foods they should eat to live longer and what cosmetics they should use to whether they are at genetic risk for cancer, Alzheimer's and other ailments, the Post said.
Critics say many of the claims are unscientific, give results too complicated for people to understand without medical help or are just plain wrong.
But others say more federal oversight will make the tests too expensive and hard to get.
"If you have things completely unregulated, then you have a Wild West of commercial interests around medical information," Robert C. Green, director of Boston University's Center for Translational Genomics and Health Outcomes, said. "If you over-regulate, you run the risk of stifling innovation in a very dynamic industry."
