The FDA banned the genetic testing company 23andMe from selling home kits designed to inform buyers of genetic predispositions relating to health, heredity, and reaction to drugs, Reuters reported. Founded in 2006 and financially backed by Google, the startup company has sold over half a million kits at $99 each (including one to Angelina Jolie), according to the Washington Post. Customers need only to submit a DNA sample (in the form of saliva) and mail it to 23andMe, where experts respond with advice based on that individual's predispositions.
But the genetics company hasn't provided scientific proof that its analysis actually works, according to the FDA.
"We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," 23andMe said in a statement. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
The company will have 15 days to "fully engaging with them" before facing potential fines and civil injunction, according to the Washington Post.
A warning letter dated Nov. 22 culminated a four year process in which the FDA has "been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device," as per the letter. In it, the drug administration worries unproven tests could "lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions."
The FDA worries about cases like Angelina Jolie, who used information gained from a 23andMe home kit to have a mastectomy.
Several publications, including Entrepreneur, Forbes, and The Washington Post, have argued against the FDA's logic. Entrepreneur compares the DNA spit kit to a pregnancy test, which also has the potential for false positives that would almost certainly lead a woman to consult her doctor rather than schedule a "home Caesarian section."
Banning the test for being inaccurate is right, admits the Post, but banning the test because it is accurate and believing people unable to judge the proper course of action is not right, according to Post blogger Timothy Lee.
