An independent FDA panel is advising more caution with the use of personal genetic tests.
The federal watchdog agency asked the advisory committee to consider whether it should introduce tougher restrictions on direct-to-consumer genetic tests due to public health and social issues.
The panel said results from such tests, which can be ordered online, can be vague or misleading.
"I would suggest that we are not ready yet to put this completely in the consumer’s hands," said panelist Joann Boughman, executive vice president 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," according to the Los Angeles Times.
“While [DTC genetic testing] enables the consumer to learn more about themselves, it also raises important questions of whether there is sufficient information available to assure that associations are real and meaningful,” the FDA wrote in an executive summary (PDF) ahead of the panel.
The FDA considers such diagnostics tests medical devices and has approved home both “collection kits,” where the test subject mails a specimen to a lab, and “test kits,” such as pregnancy tests, but believes DTC genetic tests “effectively create a third type of home use tests,” the agency wrote.
According to FDA standards, a genetic tests involve “the analysis of human DNA, RNA, chromosomes, protein, or certain metabolites in order to detect alterations related to a heritable disorder,” and cover a wide range of medical issues as disparate as cancer and Parkinson’s risk to whether a patient will respond to Hepatitis C treatment.
Any consensus after the two-day meeting, which closes today, will serve only the advise regulatory action by the FDA, but the agency typically heeds its advisory committees’ recommendations.
