FDA tells Google-backed 23andMe to stop selling genetic-testing kits
Government regulators have ordered a Silicon Valley genetic-testing startup funded by Google to halt sales of its product to consumers.
In a letter published on Monday, the Food and Drug Administration said 23andMe was selling its “Saliva Collection Kit and Personal Genome Service” in violation of federal law.
“FDA is concerned about the public health consequences of inaccurate results from the PGS device,” the agency said today. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”
In a statement, the Mountain View-based company said it was continuing to work to obtain approval from the FDA.
“We recognize that we have not met the FDA’s expectations regarding time line and communication regarding our submission,” Catherine Afarian, a spokeswoman for 23andMe, said in a statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
23andMe has been closely watched because of its role as a pioneer in the personal genetic-testing space -- and because its founder, Anne Wojcicki, is the ex-wife of Google co-founder Sergey Brin. The pair only recently made their split public.
Google is one the firms that have provided venture capital to 23andMe.
The company sells a kit and service that promises to let users know whether they are at risk for certain diseases based on their DNA.
But according to the FDA, such a product constitutes a medical device that must be approved by the agency.
23andMe, which was founded six years ago, sought FDA approval last year in a series of applications. In its letter Monday, the FDA said 23andMe did not address “the issues described during previous interactions.”
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