23andMe Is Back in the Genetic Testing Business With FDA Approval

Back in the heady Clarence Day of 2007 when 23andMe first launched its outfit , excitement was mounting over the hope of individual genetic testing , with small focus on the potential risks .

We ’re not talking about mapping your full genome here — in fact , it come to less than one percent . What 23andMe ’s test identifies are roll in the hay genetic variant in your saliva sample distribution . They ’re called single nucleotide polymorphism , or SNPs . Think of them as typographic errors that creep in when something is replicate over and over again .

There are about ten million SNPs in your genetic computer code , usually insignificant mutations with picayune to no influence on finical trait . But sometimes — either by themselves or by interacting with many other genes — they can have a very real impact on traits : how you respond to sealed drug , for case , or how at - peril you might be for a given disease . The 23andMe targets known SNPs for its genetic constitution analysis .

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You spit into a thermionic tube , then toss off your sample into the mailbox and it goes to a research lab , where your DNA is extracted from the saliva . It ’s then copied repeatedly to check that there ’s enough for analysis .

Next , your deoxyribonucleic acid is cut up and placed on a chip assay — kind of like a chicken feed microscope slide , except there are million of string of beads attached to its surface . Each bead has a slice of complemental DNA for specific SNP on the genome . It works a luck like a ignition lock and a winder . Your DNA stick to any pearl that matches whatever version of the specific single nucleotide polymorphism you have . It glows when there ’s a match , thanks to a fluorescent fixture mark .

The company account provided a statistical psychoanalysis for certain key trait based on the scientific literature to escort . For just $ 99 and a spittle sample , people could find out all sorts of fun trait : whether they had soaked or dry ear wax , how they smack jaundice , their odds of having a particular eye color , transmissible heritage , and so forth . Until November 2013 , those traits included legion disease risk of exposure factor : everything from obesity , age - relate macular degeneration(whether your eyesight will aggravate with eld ) , and alcoholism , to breast Cancer the Crab , Alzheimer ’s and Parkinson ’s .

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But the company was ahead of the regulative bender . Their reports put up specific peak and guidance on how to reduce certain health peril . Granted , it was based on the recognise scientific literature to date on genetic factors underlying certain aesculapian conditions and disease , but the scientific discipline in many typeface was far from determine and open to reading . How could a consumer be sure that the company was interpreting its event right ? And what if consumers post too much confidence in the trial results and made bad aesculapian decision base on faulty interpretation ?

So the FDA intervene , rate 23andMe to cease and desistfrom provide analysis of people ’s jeopardy factor for disease until the test ’ accuracy could be corroborate . The company still proffer selective information on ancestry base on deoxyribonucleic acid samples , but it was block from assure you anything about your wellness . Then there was aclass - legal action lawsuitalleging that thecompany misledconsumers by , essentially , over - promising what their services could offer consumer .

In February , the FDA approve 23andMe ’s test for carrier ofBloom syndrome , a rare disease associated with an increase hazard of cancer , among other symptoms . The caller quickly put together another 35 similar tests for other inherited conditions or diseases , which also passed muster with the FDA . And now they ’ve relaunched a modified adaptation of their original familial testing outfit .

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There are still restriction , however . 23andMe can only provide selective information on just those 36 tests approved by the FDA , a meaning grading back from the original kit , which gave judgement on 254 disease and condition . And the cost is now $ 199 instead of $ 99 . Technically you ’re getting less entropy for more money ; on the other hand , the information you ’re induce has the FDA stamp of approval .

The nature of the information has changed , too : the focus is on “ carrier status ” reports . The outfit will tell you whether you have a fussy genetic variate for a known genetic endowment stipulation — reap hook cellular telephone anemia , for instance , or cystic fibrosis , orTay - Sachs disease — and thus could pass this on to your offspring , even if you do n’t have the circumstance yourself . But the company is still interdict from telling you whether you ’re move to acquire a fall in genetic - connect disease in the hereafter .

Moving fore , Wojcicki order the New York Times that 23andMe still hopes to derive the FDA ’s blessing for providing health risk information to its customers , although she declined to give specifics . The society also just announced a newdrug uncovering and developmentventure , fire $ 115 million from investor .

Photo: Jae C. Hong

[ ViaThe New York TimesandPopular Science ]

Images:23andMe

remark 10/23/15 ( 1:30 PM ): The first paragraph of this Emily Price Post was edited to reflect that 23andMe was only barred from medical nosology associate to their kits .

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