Two months ago a friend of mine used 23andMe’s services and received her genetic report. The report showed a gene mutation sensitivity to a medicine used to prevent blood clots. A month later she ended up in the hospital and when the doctor asked her if she has any allergies to medicines, she gave him her 23andMe report. The doctor took the report in consideration, and ended up finding out she was in fact sensitive to it. If she hadn’t had the report, who knows what could have happened to her after receiving the medication. 23andMe is not supposed to be used as medical advice, but as possible information that you can further share with your doctor.
The FDA has now halted the sales of 23andMe’s genetic test, saying the company has failed to show that the technology is supported by science. The FDA issued a warning letter said the Google back firm has not shown that its tests are safe or effective despite “more than 14 face-to-face and teleconference meetings” and “hundreds of e-mail exchanges.” The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.
The idea of patients self managing any conditions they may have without a doctor’s input seems to be a major concern for the FDA. “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.” Doctors associations have echoed these complaints in recent years, fearing that patients aren’t able to properly interpret all that these saliva kits tell them. Direct-to-consumer genetic tests have already been banned in New York and Maryland as a result.
The FDA says it has worked tirelessly with 23andMe (over a number of years) to resolve the situation: it’s reportedly engaged in “14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications” with the company. But those discussions have apparently proven unsuccessful, and in the meantime, 23andMe has risen in popularity and ramped up marketing for DNA analysis — even airing ads on television for the first time. Now the company faces a major obstacle: it must satisfy the FDA’s requirements or face punishments including injunction, product seizures, or major fines.
In response to the FDA’s letter 23andMe stated:
“We have received the warning letter from the Food and Drug Administration,” the company says. “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.”