The FDA has written a letter to Anne Wojcicki, founder of $99 DNA testing service 23AndMe, insisting it “immediately discontinue marketing the [Personal Genome Service] until such time as it receives FDA marketing authorization for the device.” The FDA accuses Wojcicki and her company of “marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).”
Reached for comment via email, a 23andMe spokesperson provided the following statement:
“We have received the warning letter from the Food and Drug Administration. We recognize 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.”
Wojcicki told Fast Company for our November cover story that she has been working toward two goals: bringing the power of genetic testing to everyday consumers so they can better manage their own health care, and using the aggregated data from those tests to help doctors, scientists, hospitals, and researchers discover new cures for diseases that emanate from troublesome genetic mutations.
She went on to say her goal is to sign up a million customers by the end of 2013. Eventually, she said, “I want 25 million people. Once you get 25 million people, there’s just a huge power of what types of discoveries you can make. Big data is going to make us all healthier. What kind of diet should certain people be on? Are there things people are doing that make them really high-risk for cancer? There’s a whole group of people who are 100-plus and have no disease. Why?” 23andMe has about a half-million genotyped customers.
23andMe applied for medical device reviews in July and September of 2012. But today’s FDA letter insists that the reviews don’t cover all that the testing company is offering. The FDA writes, “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 problem, in a nutshell, the FDA claims, is the potential for false results that could result in someone taking incorrect or unnecessary medical action.
Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. 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. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by INR management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.
At Fast Company‘s recent Innovation Uncensored event in San Francisco, Wojcicki addressed the need for test-takers to use what they learn in cooperation with their doctor, although she discussed whether doctors were ready to handle patients who had so much personal information. “Physicians have told us that the biggest problem with 23andMe is that we generate non-billable questions. If a patient goes to their doctor and says ‘I’m at high risk for a blood clot, what do I do?’ the doctor will say, ‘Come back to me when you have a blood clot,'” Wojcicki said. “The great loophole in all of health care is that you own your own data and ultimately you can direct your care. … We’re direct to consumer not because it’s easy, but because that’s how you create a revolution.”
The FDA informs Wojcicki she has 15 working days from the date she receives the letter to spell out how she plans to address the issues or let the administration know a reasonable alternative timetable. Failure to do so could result in “regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties,” the FDA writes.