Personal DNA testing kit marketer 23andMe is mounting a defense after the Food and Drug Administration on Nov. 22 ordered the company to stop selling its kits without marketing clearance.
San Francisco-based WCG is the Google-backed company's PR agency of record and handling communications through the crisis. In a statement, 23andMe acknowledged receiving a warning letter from the FDA. "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," the company said. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
The FDA issued the warning letter to the Mountain View, Calif.-based company's CEO Ann Wofcicki on Nov. 22, ordering it to discontinue marketing its $99 Personal Genome Service until it gets FDA approval. The FDA says 23andMe has expanded the use of the product beyond its purpose submitted to the federal agency – assessing risk of genetic disease, for example -- and it fears the health consequences for a customer reacting to a false positive or negative result from a PGA test.
"We have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA," said Alberto Gutierrez, director of the FDA's Office of In vitro Diagnostics and Radiological Health.
23andMe launched its first TV ad campaign in May, "Portraits of Health," via Arnold Worldwide, highlighting the product's ability to identify genetic risk factors in users for illness and health conditions.
The company's significant financial backing – Google, Genentech, venture capital – has dropped the price of its consumer genetic tests down to $99 from nearly $1,000.
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