23andMe, the Mountain View, CA–based consumer DNA testing company that got in hot water with FDA over its lack of PMA approval for its testing for various medically significant genes, now seems to have backed off in its claims enough to appease the agency.
FDA told the company that its responses to the November 22, 2013, Warning Letter "appears to be adequate." Those responses boiled down to the company eliminating any references to its Personal Genome Service (PGS) having any utility in the "cure, mitigation, treatment, or prevention of disease."
So now they're selling the service, at the same price, merely as an ancestry-related genetic report, with uninterpreted raw genetic data. The company's website says, "We no longer offer our health-related genetic reports" and claims to be the "largest DNA ancestry service in the world."
Reading through that November Warning Letter is instructive.
According to FDA, the company was marketing its saliva-based tests to provide "'health reports on 254 diseases and conditions,' including categories such as 'carrier status,' 'health risks,' and 'drug response,' and specifically as a 'first step in prevention' that enables users to 'take steps toward mitigating serious diseases' such as diabetes, coronary heart disease, and breast cancer."
The Warning Letter described how the Agency had been working with 23andMe since 2009, "providing more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications." And the company apparently did little to resolve the issue.
The Warning Letter continues, "You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, 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."
No wonder they shut them down.
In a blog posted on 23andMe's website, "'My main priority is resolution with the FDA,' our CEO and co-founder Anne Wojcicki said recently." And, "In that effort, 23andMe scientists and executives have met and communicated directly with FDA officials on a number of different occasions over the last few months."
A quick search on the Securities and Exchange Commission's website revealed that Google has invested a total of $5.8 million in 23andMe in two separate rounds. Now, they likely have deep enough pockets to finance all that clinical testing, but will they?
Stephen Levy is a contributor to Qmed and MPMN.
