Why the Federal Government Is Cracking Down on 23andMe for Offering Personal Genetic Testing
Photo Credit: Shutterstock.com/ Sergey Nivens
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Until recently, if a person had about $100 to spare, she could purchase 23andMe's Personal Genome Service. After sending in a swab of saliva she would receive a genetic breakdown, detailing ancestral background and risks for certain diseases.
23andMe, founded in 2006, offers customers personal genetics tests and helps them understand what existing scientific literature says about their personal genome sequence. In 2008 Timemagazine named 23andMe's saliva test "Invention of the Year."
Co-founder and chief executive Anne Wojcicki has promoted the company as offering the public an opportunity to take control of their health outcomes by understanding their DNA.
The Personal Genome Service (PGS) is a relatively affordable package—especially for one that claims to contain insight into the past and future—which the company argues restores agency to someone seeking personalized medical information. It’s been popular with adoptees looking to reconnect with biological family and with people interested in knowing whether they are genetically predispositioned for certain diseases. With high-profile celebrities like Angelina Jolie discussing the BRCA gene and breast cancer, interest in tests like PGS is growing.
But not everyone is enthusiastic about that prospect, including the U.S. Food and Drug Administration. While the Google-backed 23andMe does not prescribe drugs or medication, it is apprising its customers of certain health problems for which they are at more or less risk according to their genetic information. Therefore, according to the FDA, the company is subject to regulation.
On November 22, the FDA sent the company a second warning letter asserting that until 23andMe was granted authorization to market its PGS as a device for medical advice, the company could not carry on advertising the product as such.
As Michael Hiltzik wrote in the LA Times, “The reports issued by 23andMe prior to the FDA letter typically included pages of qualifications of the genetic results for every health issue, followed by a broad disclaimer stating that the information ‘is intended for research and educational purposes only, and is not for diagnostic use.’"
Critics contend that not everyone makes it to the disclaimer, and that this kind of information should be delivered by trained medical professionals.
“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment,” states the FDA’s second letter.
The FDA’s concerns are not new.
The first warning letter was sent to 23andMe, along with four other prominent personal genomics companies, back in June 2010. Two years later, 23andMe applied for approval for a de novo classification—meaning a low-risk device of the PGS—with the FDA, but has yet to address the federal agency's concerns.
The FDA's November letter emphasized that it had been in ongoing communication with 23andMe since the company first applied for marketing authorization in the summer of 2012:
As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.
The letter revealed that 23andMe had stopped responding to the FDA's attempts to resolve the issue last May: “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.”