The Food and Drug Administration has sharp words for a genetic diagnosis kit that, it claims, hasn't been proved to work as advertised. In a harshly written letter to 23andMe, the federal agency accuses the company of marketing its over-the-counter DNA test in ways that mislead consumers and could unwisely convince them to self-treat, with potentially deadly results.
The test claims to be able to identify 254 conditions based on biological samples that consumers send back to a lab. The lab is staffed by "expert technicians," according to 23andMe's Web site, and can tell you everything about your vulnerability to diabetes, heart disease and breast cancer long before any of these diseases manifest themselves.
The problem? 23andMe's OTC kits may be just as likely to report false positives or false negatives, according to the FDA. And that misinformation could wind up putting people in life-threatening treatment scenarios.
"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," the letter reads, "while a false negative could result in a failure to recognize an actual risk that may exist.
"False genotype results for your warfarin drug response test," the letter continues, "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."
Patients engage in potentially problematic self-diagnosis all the time. The Internet, with its wealth of medical information, has made it incredibly easy to become a hypochondriac. But unlike the Internet, 23andMe is a commercial product that makes specific health appeals directly to consumers — and that means it requires federal approval.
Although the FDA says it's met with 23andMe on 14 separate occasions and exchanged "hundreds" of e-mails to discuss doing studies that would provide the missing safety data, the company is nine months late in submitting its reports proving the diagnosis kit actually works. The kit itself has been available for five years.
Without the proper evidence to make a judgment one way or another, the FDA has ordered 23andMe to stop marketing its product.
Update: A 23andMe spokesperson says in a statement that the company has received the letter. "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."