Genetic testing company 23andMe ordered by the FDA to halt sales

PUBLISHED : Tuesday, 26 November, 2013, 9:31pm
UPDATED : Wednesday, 27 November, 2013, 1:53am


US government regulators have ordered a Silicon Valley genetic-testing company funded by Google to halt sales of its product.

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 device," the agency said. "The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."

In a statement, the California-based company said it was continuing to work to obtain approval from the FDA.

"We recognise that we have not met the FDA's expectations regarding time line and communication regarding our submission," 23andMe spokeswoman Catherine Afarian 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 personal genetic-testing - 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 of the firms that has 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 the FDA says such a product is 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 on Monday, the FDA said 23andMe did not address "the issues described during previous interactions".