23andMe quickly gained notoriety by providing private client with wellness and lineage entropy directly from their sequenced DNA , then , in 2013 , it wasstopped from provide wellness detailsby the FDA . Now it ’s got the green light to re-start .
TheNew York Times reportsthat , two geezerhood later , the company has gained FDA approval to distribute health information — though the insights it will be able to provide are much more special . In the past , 23andMe supply customer with information about their risk of infection of develop a range of diseases base on their DNA sample ; now , it will just be capable to allow for entropy about the risk of passing some inherit disease on to children .
The new report will provide details about what ’s known as ‘ bearer position ’ . The tests will name genetic mutations in DNA samples that could lead to the qualifying of one of 36 disease — including cystic fibrosis , sickle mobile phone anemia and Tay - Sachs — on to materialization . In each example , the disease would only be fall on if both parents shared the same mutation and the child inherit both mutated factor .
23andMe is now to raise the price of its service from $ 99 to $ 199 . It ’s also launching a revamped website , which it hopes will make it easier to interpret the results of its tests .
Back in 2013 , the FDA wrote a varsity letter to 23andMe explaining that it was “ concerned about the public wellness consequences of inaccurate result from the [ 23andMe ] twist , ” adding that “ the main purpose of compliance with FDA ’s regulatory requisite is to check that the tests work . ” The FDA went on to advise that false positives or false negative on the test could lead to startling results .
Clearly 23andMe has demonstrated to the FDA that its tests are precise enough to confirm carrier status , though it remains unreadable how commercially popular such tryout will try — peculiarly collapse that other , alike trial are already available through other labs . No surprise , then , that theNew York Times also notesthat the caller still hopes to gain FDA approving to try out for personal wellness risks , too .
That advance , however , is likely still a means off .
[ New York Times ]
23andMeBiologygenetic testingScience
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