Google diagnostic firm receives scathing FDA warning
pharmafile | November 26, 2013 | News story | Medical Communications, Research and Development, Sales and Marketing | FDA, dna. 23andme, google
The Google-backed DNA testing firm 23andMe has received a warning letter from the FDA saying it cannot continue to market its product without regulatory approval.
In a warning letter dated 22 November and released on Monday, the FDA said it considers the company’s product a medical device that therefore requires regulatory clearance “as FDA has explained to you on numerous occasions”.
It is now demanding that the firm immediately cease selling and marketing its DNA testing service until it receives clearance from the agency.
The FDA said some of the intended uses of the company’s Saliva Collection Kit and Personal Genome Service are ‘particularly concerning’, including risk assessments for certain cancers.
The US regulator said that if the company’s risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo preventative surgery, intensive screening or other potentially risky procedures.
A false negative on the other hand, could result in a failure to recognise actual risk.
The FDA said in its letter that the company submitted applications in July and September of 2012 for several of these indications for use.
It added: “To date your company has failed to address the issues described during previous interactions with the agency or provided additional information requested.” As a result, the FDA said the applications ‘are considered withdrawn’.
The agency said its interactions with the company included more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications.
“However, 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,” the agency added.
Of the personal genome testing companies – of which there are many – 23andMe may be the best known chiefly because it is backed by Google. The firm is also run by Anne Wojcicki, the wife of Google founder Sergey Brin, though they are now separated.
23andMe’s $99 (£61) test is sold only through the company’s website and has been used by around half a million people. It analyses the DNA in a saliva sample to tell consumers, among other things, whether they might be at a higher or lower risk of developing certain diseases.
The company’s name refers to the 23 pairs of chromosomes that make up each individual’s genome.
It said in a statement: “We have received the warning letter from the Food and Drug Administration. We recognise that we have not met the FDA’s expectations regarding timeline and communication regarding our submission.
“Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.” The company now has two weeks to respond to the FDA.
FDA criticised
Many users of the product took to the firm’s Facebook page and Twitter yesterday, using the #23andme hashtag to voice disapproval of the FDA’s actions.
Mark Lemley, a Professor at Stanford Law whose Twitter handle is @marklemley, says: “FDA thinks a plastic cup is a ‘device’ you need its approval to deliver (and an ‘adulterated’ one at that)”.
Robert West PhD, also said: “Big Medicine (Goliath) versus Google-backed 23andMe (David) .. Fingers crossed for an upset…”
Alec Muffett a UK speaker on digital issues, added: “FDA decides that you’re not allowed to know your own genome without regulation, slaps down”.
There were similar reactions across other media. Posting on the firm’s Facebook page, Grant Williams said: “Pathetic. The FDA has no right to tell me what I can learn about my own genetic information.”
There is also now a petition on the official White House page asking for the government to “overrule the FDA’s decision to bar 23andMe from selling their potentially life-saving diagnostic kits”.
It currently has fewer than 2,000 signatures – it requires 100,000 to be looked at by the government.
Ben Adams
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