The head of genetic-test maker 23andMe Inc. responded to a Food and Drug Administration warning letter in a blog post Tuesday night, acknowledging the company was behind schedule in addressing FDA concerns but defending the accuracy and value of the company’s tests.
The FDA ordered the Google-backed company to stop marketing its $99 genetic test in a Friday letter, saying the company hadn’t secured marketing authorization and expressing concern that inaccurate results could lead consumers to undergo unnecessary health procedures such as breast-cancer surgery.
The FDA said 23andMe hadn’t responded to numerous requests for more information, even as the company was launching a national television advertising campaign for the product, which analyzes genetic information from a person’s saliva for clues about disease risk and ancestry.
The company began marketing its tests in late 2007.
In a post on the company’s website, CEO Anne Wojcicki said 23andMe began discussions with the FDA in 2008, and submitted its first application for FDA clearance last year.
