At the end of 2013 , 23andme was order tostop sell its DNAtesting kit health reports by the Food and Drug Administration . Now , the FDAhas grantedthe ship’s company favorable reception to sell a single test for the markers of Bloom Syndrome , a rarefied hereditary disease .
Bloom Syndrome is link up with short height , sun sensitivity , and increase Crab risk . Sufferers develop any of the cancers found in the general population , but onslaught is typically other and multiple types often develop more chop-chop .
The conclusion by the FDA allowing 23andme to sell the kit is the first time it ’s actually approved a “ unmediated - to - consumer ” genetic mental testing . The FDA has also said that it will reclassify these kinds of kit , meaning that they will be nontaxable from premarket review .
Back in 2013 , official were concerned “ about the public wellness consequences of inaccurate results from the … gimmick . ” The FDA went on to suggest that false positives or put on negative on the test could lead to startling consequences — like woman getting unnecessary mastectomies . It turned out that people take such genetic testing somewhat gravely !
That s why the new favourable reception only allows tests for single diseases to be sold . Butin a blog place , 23andme writes that it come across this as “ an important first step in accomplish our loyalty to return genetic wellness reports to consumer in the US . ” In other word , it ’s hoping that this paves the mode for approval of its original offer . Only metre , and the FDA , will differentiate . [ 23andme , FDAviaVerge ]
Image byShutterstock / isak55
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