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A high bar is likely to be set for companies seeking to sell genetic tests directly to consumers, according to top Food and Drug Administration officials.
The agency is convening a two-day public hearing starting Monday to discuss how it would regulate diagnostic tests, including direct-to-consumer tests.
In an interview, Jeffrey Shuren, head of FDA's medical-devices division, and Alberto Gutierrez, who oversees the FDA unit that regulates certain laboratory tests, said they considered direct-to-consumer genetic tests "high risk" and have already informed companies selling such tests through their websites that their tests appear to be medical devices requiring FDA approval.
Mr. Shuren suggested it could be difficult for direct-to-consumer tests to gain agency approval the way they are currently marketed. Mr. Shuren said he was concerned about cutting doctors out of the process of interpreting laboratory tests and afraid consumers could make risky medical decisions based on information that suggests they are at risk of developing cancer, diabetes or other diseases or could stop taking a needed medication.
The issue came to light in May after Pathway Genomics Corp., a...
The agency is convening a two-day public hearing starting Monday to discuss how it would regulate diagnostic tests, including direct-to-consumer tests.
In an interview, Jeffrey Shuren, head of FDA's medical-devices division, and Alberto Gutierrez, who oversees the FDA unit that regulates certain laboratory tests, said they considered direct-to-consumer genetic tests "high risk" and have already informed companies selling such tests through their websites that their tests appear to be medical devices requiring FDA approval.
Mr. Shuren suggested it could be difficult for direct-to-consumer tests to gain agency approval the way they are currently marketed. Mr. Shuren said he was concerned about cutting doctors out of the process of interpreting laboratory tests and afraid consumers could make risky medical decisions based on information that suggests they are at risk of developing cancer, diabetes or other diseases or could stop taking a needed medication.
The issue came to light in May after Pathway Genomics Corp., a...