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Members of a Food and Drug Administration advisory panel convened to consider new government regulation of genetic testing offered directly to consumers said Tuesday that such testing should only be allowed under a doctor's supervision.
Personal testing, which is mainly available online from companies operating outside traditional medical institutions, can produce ambiguous or misleading results without proper analysis, members of the panel said.
"I would suggest that we are not ready yet to put this completely in the consumer's hands," said panelist Joann Boughman of the American Society of Human Genetics. "Each test is complex and when you have each provider doing slightly different tests, it complicates it even more."
The panel's consensus on new regulations is not binding on the FDA, but the agency usually follows the panel's advice.
The 21-member panel, predominantly a mix of physicians and academics, did not vote on specific questions during the first day of a two-day hearing which will conclude Wednesday. But members expressed general agreement that doctors should be in charge of ordering and interpreting the tests.
Panelists expressed particular concern that...
Personal testing, which is mainly available online from companies operating outside traditional medical institutions, can produce ambiguous or misleading results without proper analysis, members of the panel said.
"I would suggest that we are not ready yet to put this completely in the consumer's hands," said panelist Joann Boughman of the American Society of Human Genetics. "Each test is complex and when you have each provider doing slightly different tests, it complicates it even more."
The panel's consensus on new regulations is not binding on the FDA, but the agency usually follows the panel's advice.
The 21-member panel, predominantly a mix of physicians and academics, did not vote on specific questions during the first day of a two-day hearing which will conclude Wednesday. But members expressed general agreement that doctors should be in charge of ordering and interpreting the tests.
Panelists expressed particular concern that...