Aggregated News
Indicating they plan to closely monitor the sale of genetic tests directly to consumers, federal regulators Friday told five companies involved in the business - including two in the Bay Area - their products are medical devices that require the government's approval.
Among the companies the Food and Drug Administration notified were Navigenics of Foster City and Mountain View-based 23andMe.
In letters to the companies, the FDA said neither had "submitted information on the analytical or clinical validity" of their tests, which the companies promote as helping consumers understand their genetic predispositions so they can better manage their health.
Noting that some medical devices can harm people, the letters added, "it is important that they be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations."
The other companies notified were Illumina of San Diego; Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores....
Among the companies the Food and Drug Administration notified were Navigenics of Foster City and Mountain View-based 23andMe.
In letters to the companies, the FDA said neither had "submitted information on the analytical or clinical validity" of their tests, which the companies promote as helping consumers understand their genetic predispositions so they can better manage their health.
Noting that some medical devices can harm people, the letters added, "it is important that they be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations."
The other companies notified were Illumina of San Diego; Knome of Cambridge, Mass.; and deCode Genetics of Lake Barrington, Ill. The FDA sent a similar letter in May to Pathway Genomics of San Diego, after Pathway announced it intended to sell its tests through Walgreens drugstores....