23andMe Inc., the Google Inc. (GOOG:US)-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.”
The Saliva Collection Kit and Personal Genome Service, or PGS, tells users whether they carry a disease, are at risk of a disease and would respond to a drug. Most of the uses fall into the category of a medical device and require Food and Drug Administration approval, the agency told the Mountain View, California-based company in a Nov. 22 letter made public today.
Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin, started 23andMe about six years ago to help people assess their risk of cancer, heart disease and other medical conditions. Brin used the saliva kit to determine he had a gene that makes him susceptible to Parkinson’s.
“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.”
The FDA used candid language in the letter to outline the work the agency has done with 23andMe since 2009 to no avail, including more than 14 face-to-face and teleconference meetings and had hundreds of e-mail exchanges. The FDA said it has given the company feedback on study protocols, discussed regulatory pathways and provided statistical advice.
“Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions,” the FDA wrote.
The agency said it hasn’t heard from 23andMe since May and meanwhile the company has initiated new marketing campaigns, including television commercials, indicating 23andMe plans to expand the device’s use without obtaining FDA marketing clearance.
The FDA decided in 2010 that services claiming to evaluate a customer’s risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe’s would be the first to test for multiple conditions.
“We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission,” Catherine Afarian, a spokeswoman for 23andMe said in an e-mail. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews. The FDA said the company failed to address “the issues described during previous interactions.”
UnitedHealth Group Inc. (UNH:US), the largest publicly traded U.S. health insurer, raised concern in a March 2012 report about the accuracy and affordability of the tests. Such types of genetic tests may become a $25 billion annual market in the U.S. within a decade, highlighting the need to identify which work best, the insurer said at the time.
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