The FDA has give personal genetics company23andme15 days to comply with health regulations , before the Union delegacy begins clutch the company ’s DNA examination kits . The FDA says 23andme is pop the question an untested “ diagnostic ” machine in intrusion of the Federal Food , Drug and Cosmetic Act .
For $ 99 , 23andme will send you a DNA collection kit and sequence cardinal regions from your whole genome . The ship’s company promises to reveal your possible wellness risks and assets , as well as ancestry selective information .
For the past several eld , the FDA has push 23andme to offer strong grounds that its kits sour as advertised , and the government agency say the company has done nothing to abide by . It appears that talks between the caller and the agency break up down , and 23andme has not been in touch with the FDA since May of this year .
The FDA ’s master worry is 23andme ’s claim that it can offer up information on medical conditions , which multitude may attempt to treat without medical supervising . One possible scenario is that people who take 23andme ’s tryout , and get a false positive , will try out many other expensive medical tests and treatment ( including surgery ) that are unneeded . instead , people may be falsely reassured by a 23andme examination that indicate they have no predisposition for genetic disease , and not heed wellness warning sign when they develop .
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Specifically , the FDA highlight “ the potential health consequences that could result from assumed positively charged or false negative judgment for gamy - endangerment indications such as these . ” As one exercise , the FDA points out that a sham convinced for tit or ovarian malignant neoplastic disease could “ lead a patient role to undergo prophylactic surgery , chemoprevention , intensive screening , or other morbidity - inducing actions . ” On the opposite end , a false negative could “ leave in a failure to recognize an actual peril that may live . ”
The theme of patient self managing any experimental condition they may have without a doctor ’s input seems to be a major concern for the FDA . “ The risk of serious wound or decease is known to be high when patients are either non - compliant or not decent dose ; combined with the risk of exposure that a direct - to - consumer exam answer may be used by a patient to self - manage , serious concerns are raised if test termination are not adequately see by patient or if incorrect examination answer are reported . ” Doctors associations have repeat these complaints in recent old age , dread that affected role are n’t capable to by rights interpret all that these saliva kits say them . Direct - to - consumer genetical testshave already been bannedin New York and Maryland as a result .
One of the FDA ’s repeated requests has been that 23andme must adequately establish the accuracy of its tests .
This FDA move may have logical implication for other transmissible examination service , and possibly services that essay the human microbiome as well .
Read the FDA’sfull warning letter to 23andme , where it issues its 15 day ultimatum .
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