US FDA hs Indicated that they plan to closely monitor the sale of genetic tests directly to consumers, Te FDA Friday told this to 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 US 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.
Navigenics has been consulting with the FDA about its operations for more than three years, Amy DuRoss, vice president of policy and business affairs, said in a prepared statement. “We are the only personal genomics company that is approved by state regulators to operate in every state, and we welcome federal oversight as the next stage in that evolution,” she added.
Officials at 23andMe said they have had discussions with the FDA since October 2007. “It is important to note that we disagree with the FDA’s conclusion,” a company statement said. “Regardless, we have always been open to discussions to formulate a rational way to regulate the personal genetics industry.”
It was unclear what penalties — if any — companies might face if they continued selling genetic tests to the public without the agency’s approval. Still, having the FDA get involved in the marketing of such products is “a fairly significant event because this is a type of activity that the FDA heretofore has not regulated, for the most part,” said Gail Javitt, a research scholar with the Johns Hopkins Berman Institute of Bioethics.
Jesse Reynolds of the Berkeley-based Center for Genetics and Society agreed.
“It’s a positive step and an overdue step,” he said, because some consumers may use information from the tests in dangerous ways, such as adjusting the dosages on their prescriptions without consulting a doctor.
Critics have questioned the value of some companies’ tests, which can cost thousands of dollars, because they say they provide only a limited sample of a person’s genetic makeup. And two years ago, the California Department of Public Health launched an investigation into the marketing of such tests, saying some companies lacked proper state licenses.
On June 4, 23andMe also disclosed that a laboratory it uses made an embarrassing goof with some genetic samples. “Up to 96 customers may have received and viewed data that was not their own,” it said. The company added that it is instituting “safeguards to help assure that similar incidents do not occur in the future.”