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(CORRECTION 4/17/14: An beforehand adaptation of this commodity declared that 23andMe barter could abandoned accord out of abiogenetic bloom analysis by closing their accounts. This is incorrect. While customers’ abstracts can consistently be acclimated for centralized analysis accompanying to artefact development, 23andMe’s bloom analysis has a able-bodied accord activity on an opt-in basis.)

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By Aaron Krol 

March 24, 2014 | There’s a abracadabra cardinal that Anne Wojcicki sometimes invokes aback she’s out on the media circuit. As co-founder and CEO of 23andMe, and a arch advocate for genomic medicine, it’s not abnormal to see Wojcicki in a TV flat talking up the allowances of claimed abiogenetic testing. From WSJ Live to CBS This Morning, Wojcicki has acclimated her abracadabra cardinal to persuade admirers that affairs 23andMe’s Claimed Genome Annual (PGS) is an beforehand in a new eyes for medicine.

The cardinal is one million, and it’s explained in a post Wojcicki wrote for the 23andMe blog in December 2012, announcement a bead in the amount of the PGS from $299 to $99:

One million barter can be the angled point that moves anesthetic into the molecular era…  A abiogenetic abstracts adeptness of this consequence has enormous abeyant to abode changing questions accompanying to the contributions of genes, the ambiance and your health… [This is] an aggressive plan that could transform anesthetic for ancestors to come.

You alpha to get a faculty of Wojcicki’s articulate style. Still, the alternation of anticipation is attainable to follow: 23andMe wants to advice you adverse any dangers ambuscade in your genome by acknowledgment what your DNA says about your approaching health. This annual requires a lot of analysis into which abiogenetic variants are complex in which diseases. 23andMe is blessed to do that analysis itself, but it needs lots of data; in fact, it needs one million customers, with genotypes and claimed bloom information, to adeptness a tipping point breadth discoveries will appear faster and faster. In following of that goal, the aggregation will activity a abrupt abatement on its service, aloof to get your data in the calmly of its researchers.

23andMe anticipation this criterion of one actor customers could be accomplished by aboriginal 2014. And for eleven months the activity hummed along smoothly, with almanac numbers of Americans battery out $99 and a canteen of saliva for a blink at their genes and a adventitious to advice accomplish Wojcicki’s healthcare transformation a reality.

Then, on November 22, 2013, the FDA beatific a letter to 23andMe’s abode in Mountain View, California, writing, “23andMe charge anon abandon business the PGS.”

Fateful Choices 

In 2006, Joyce Tung was working as a post-doc at Stanford, researching the abiogenetic abject of bark pigmentation, aback she saw a flyer announcement jobs at a new startup alleged 23andMe. “I was on my way to do a Southern blot, which is a terrible, abhorrent experiment,” she remembers. “So I was apparently decidedly attainable to advancement at the time. I thought, this is absolutely what bodies affliction to be accomplishing with genetics.”

It was the year that personal abiogenetic testing seemed to accomplish it into the air. Falling costs of DNA analysis were fueling the analysis of single-point mutations affiliated to a advanced ambit of diseases, including Alzheimer’s, abdominals disease, and a array of cancers. 23andMe was aloof one of several companies – Navigenics and deCODE analysis amid them – who had absitively the time was accomplished to about-face abiogenetic bloom testing into a commercial service.

Tung started alive as a architect for the beginning company, and became a full-time agent the following year. Forth the way, she best up the spirit of authentic populism that has helped cast 23andMe as a array of insubordinate bloom reformer. “We were really aflame about authoritative analysis attainable to people,” she says of her aboriginal days at the company. “Science should aloof be added attainable to people, and I think we were all aflame about demography commodity that had ahead been bound up in airless old journals, and bringing it to the draft of the world.”

 

23andMe’s Mountain View address in 2011. Reprinted with permission of the artist 

In 2007, 23andMe was not yet accomplishing centralized research. Tung’s aboriginal antecedence as a affiliate of the scientific agents was architecture the letters that barter would see: their ancestry information, a scattering of assorted traits, and best importantly, their ache risks.

This is glace territory, because our adeptness of the abiogenetic contributors to ache is so incomplete. The aggregation had to decide, with no bright precedent, which altitude to accommodate in the PGS reports. This complex combing through the authentic abstract for studies that appear gene-disease associations. “We accept a appealing robust activity for free which studies we anticipation were the best valid,” says Tung. “That was a accord amid the agreeable aggregation and the analysis team.”

One aboriginal accommodation in particular may accept larboard a ample authoritative footprint. Aback 23andMe’s bloom letters show a customer’s accident for a accustomed disease, they don’t artlessly agenda an association amid gene and phenotype as a annual commodity would. Instead, they specify a percent adventitious of accepting that ache over a lifetime. To accomplish these risk figures, the authentic aggregation congenital a set of algorithms that accede the prevalence of anniversary disease, an appraisal of how anniversary abiogenetic alternative skews the odds, and some claimed advice supplied in the customer’s profile, most chiefly indigenous background. (Tung, for instance, who abstruse from her own PGS that she is 100% Chinese, would accept altered accomplishments ache risks than her husband, who has Native American, African, and European ancestry.)

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“Those algorithms were derived aback we had aloof one science team,” says Tung. “We weren’t that big, and we didn’t bisect the accumulation into analysis and not research. We aloof had a accumulation of scientists who formed calm on those algorithms.”

The algorithms are significant, because one of the FDA’s bigger apropos with direct-to-consumer genetic testing has been users overreacting to abiogenetic risks, abnormally if they get incorrect information. The cerebral aberration amid seeing that you backpack a abiogenetic alternative complex in affection disease, and seeing that 23andMe estimates a “30% chance” of developing affection disease, may be profound. In its November letter, the FDA references the PGS address on BRCA mutations, which announce aerial risks of breast cancer, warning that a 23andMe chump with a apocryphal absolute BRCA aftereffect adeptness blitz out to get accidental “prophylactic surgery” – i.e., a mastectomy.

If you anticipate that sounds a little hysterical, you’re not alone. Misha Angrist, of the Duke Institute for Genome Sciences and Policy, was aloof one of abounding assemblage who advised this book “borderline absurd

At affair are the accompanying questions of analytic and analytic validation: whether 23andMe’s microarrays correctly genotype its customers, and whether its interpretations of those genotypes – the accident percentages – are well-supported by affirmation and acutely explained. The above is adequately attainable to prove; the latter, abundant added difficult.

The Added Shoe 

To accept the stakes here, we accept to get a bit into the weeds of the FDA’s medical accessory classifications.

By 2013, 23andMe was the only aggregation still alms barter bloom advice based on their genotypes, and for four years, it had been altercation with the FDA over commodity alleged a 510(k). This is a address to amusement a new product, like 23andMe’s PGS, as a chic II medical device, rather than a added carefully adapted chic III device, the absence for atypical products. A 510(k) is a accustomed avenue for new in vitro tests, which rarely affectation the “potential absurd accident of affliction or injury” that defines chic III.

23andMe’s PGS is about an in vitro analysis – discharge sample in, answers out – so this would assume like the company’s best bet for clearance. Unlike chic III devices, which go through the backbreaking activity of premarket approval, tests in chic II abandoned charge to accommodated some mutually agreed-upon standards for labeling and affection controls, to assure the FDA that the analysis is authentic and accustomed by users. In short, analytic validation is acute for both classes of test, but in chic III, analytic validation is abundant added prominent.

That was the chat the two abandon were accepting amid July of 2009 and ancient in aboriginal 2013. The FDA letter recounts “more than 14 contiguous and teleconference meetings, hundreds of email exchanges, and dozens of accounting communications” in this time, through which the bureau advised business pathways, what disclaimers the PGS should carry, and whether at atomic assertive ache risks appear in the PGS could appropriately abatement beneath chic II regulations.

Sometime in aboriginal 2013, however, it appears that 23andMe absitively to draft off the 510(k) activity – perhaps bank that it could get abroad with not actuality classed as a medical accessory at all. In backward 2012, the FDA beatific the aggregation requests for additional information, which were never addressed. In March 2013, the FDA informed 23andMe that its 510(k) was advised withdrawn. Finally, in May, 23andMe chock-full acknowledging to the FDA’s communications. This has been the best shocking adumbration of the FDA letter, what Matthew Herper of Forbes alleged “the distinct dumbest regulatory activity I accept seen in 13 years of accoutrement the Food and Biologic Administration.”

Seen in this light, it’s almost hasty that the FDA waited until November to accede that the PGS fell by absence beneath chic III, did not accept premarket approval, and could not be sold.

After 14 canicule of application and acute media attention, 23andMe accomplished a aching compromise: it could abide affairs the PGS, but all bloom advice was bare from the reports. Abandoned the raw genotypes and ancestor advice remained. This has been a austere draft to the company’s adeptness to allure customers, as Wojcicki accustomed in an actualization at the SXSW Festival in Austin aftermost week, adage that the FDA activity “has slowed up the cardinal of bodies signing up.”

She additionally appear how many barter accept bought into the PGS so far: 650,000. That’s a lot of genotypes, but it’s not the abracadabra one million.

Before the FDA action, it didn’t abundant amount whether one actor barter was absolutely the angled point for analysis in abiogenetic medicine. It was advantageous buzz, a way to affect bodies on the fence about claimed analysis to join in. Now, with signups adjourned abbreviate of the accomplishment line, one has to ask: will two-thirds of a actor do?

“We Are Attractive to Appulse People’s Health” 

Tung, who comes beyond as mellow but approachable and has a addiction of adage gosh or shoot aback she’s cerebration over a question, is awash with activity for her work. Today, she’s 23andMe’s Director of Research, analogous the projects that assignment through customers’ genotypes for new allegation on heredity. Aback Wojcicki talks about the analysis ability of one actor customers, Tung’s assignment is what she wants you to anticipate of.

The basal arrangement of these projects is a constant. 23andMe creates chump surveys allurement about traits that the analysis aggregation believes may accept a abiogenetic basis. The aggregation casts a advanced net, exploring aggregate from Parkinson’s ache to motion sickness, from accident factors for diabetes to accident factors for smelling asparagus in pee. Tung estimates that there are about 50 of these surveys now in circulation, forth with hundreds of one-off questions.

 

The aeon of claimed genetics, as apparent in an aboriginal 23andMe blog post. Image credit: 23andMe 

The aggregation additionally food troves of abiogenetic abstracts on anniversary of its customers, the fruits of its genotyping service. In its latest version, the custom 23andMe microarray dent captures aloof over 600,000 distinct nucleotide polymorphisms (SNPs) from anniversary user’s genome. (That’s absolutely a abundant abatement from the antecedent chip, but 23andMe is assertive it has zeroed in on added advisory SNPs now, and that abounding of the SNPs it alone can be accustomed from the abstracts it has already.) Compare the SNPs to the analysis answers, and trends may activate to emerge.

So which ancestor is 23andMe most absorbed in? Blight or aback hair? Accustomed the FDA’s crackdown on bloom results, I bisected apprehend Tung to cossack a bit on this question, but she doesn’t hesitate.

“We are attractive to make discoveries that appulse people’s health,” she says firmly. “So we do affliction a lot about the added medically accompanying conditions. And we additionally affliction about people’s acknowledgment to altered treatments.”

Treatment responses are an breadth 23andMe is well-positioned to study, acknowledgment to its advice on customers’ medication histories. “At this point, we accept some barter who accept been with us for over six years,” Tung credibility out. “It’s advantageous to attending at [their drug responses] over time. It’s abundant to apperceive aback they started demography the medication, and if and aback they started to see after-effects or ancillary effects.”

This affectionate of longitudinal abstracts is advised the gold accustomed for analysis in abiogenetic health. The affluence with which Tung’s aggregation can aggregate this advice is a above advantage of working with an complex user association like 23andMe’s chump base. Breadth other studies would accept to go to abundant lengths to accumulate and genotype a accomplice of medication users, 23andMe aloof acclamation its customers.

When I ask Tung if she has any admired findings, she brings up a cardboard her aggregation appear in Attributes Analysis aftermost October, anecdotic regions of the genome associated with allergies.

“That was appealing cool,” she says. “It’s agitative to accomplish discoveries in a acreage breadth there’s not a ton of, say, government funding, because allergies don’t annihilate the cardinal of bodies that blight or cardiovascular ache do. But they absolutely appulse people’s lives, and a ton of bodies accept them. So aggravating to accept how bodies develop allergies, what makes them susceptible, and how we adeptness be able to amusement them, is commodity I absolutely appreciate.”

It’s a acceptable example, demonstrating a absolute unmet charge that 23andMe can fill, by belief conditions of acute affair to accustomed bodies but beneath absorption to acceptable funding bodies. The cardboard additionally appeared in a top-tier journal, which, admitting Tung’s beforehand crowd at “stuffy old journals,” offers 23andMe some much-needed absolution of its methods. Analysis after-effects are not consistently accustomed as reliable measures of analytic phenotypes, although Tung insists that “as continued as you’re allurement the appropriate questions, they’re as acceptable as a medical record.”

Now that 23andMe is barred from advertisement its discoveries to barter directly, publishing in scientific journals may be added important than ever. “We’ve consistently published, and I anticipate we intend to continue,” says Tung. “Our ambition is to beforehand biomedical research, and allotment of that is sharing our allegation with the authentic community.”

 “Certain kinds of allegation are [also] fabricated available via our blog, to our barter and added fans,” she adds. That raises a abstract catechism about the FDA activity adjoin 23andMe. The aggregation can still column its allegation in accessible forums – in fact, there’s apparently no acknowledged action the FDA could booty to stop this if it capital to. And the bureau has signaled it’s not absorbed in blocking companies from alms bodies their raw genetic data. So 23andMe users could apparently aloof accumulate beside of new findings from the company, and analysis their own genotypes adjoin any variants flagged in the research.

Most won’t bother, of course. It’s a huge altercation to burrow through the accordant literature, and chase your genotype for variants one by one. But it’s appropriate to anticipate that our current civic accord on claimed analysis is that you can accept your genotype – or alike your accomplished genome, if you can acquisition addition to arrangement it – and you can accept all the advice you appetite on abiogenetic ache risks, but you can’t have both in the aforementioned place.

Research and Commerce 

It’s not bright how abundant the analysis aggregation will accept to acclimate its methods to the new authoritative realities. On the one hand, it will absolutely accept a harder time accession new data. And there’s affluence of befalling for the agreeable and business teams to influence the beforehand of research, if they anticipate it could advice draw barter in. “The company’s not that big,” says Tung. “We all eat cafeteria calm every day, so we accumulate the curve of advice open. “

On the added hand, the company’s analysis aesthetics hasn’t been forgotten. Asked if 23andMe will now focus more on the ancestor advice it can accurately allotment with customers, Tung says, “The mission of the aggregation charcoal on health. Obviously we’re absorbed in ancestor as well, but it’s still our ambition to beforehand biomedical research. I don’t anticipate that’s changed.”

As the affairs of extensive one actor barter alpha to flag, added than 23andMe’s aboriginal analysis is at stake. Assemblage accept generally appropriate that 23andMe’s $99 kits, which are notably beneath big-ticket than agnate genotyping services, are a accident baton for its real business of affairs customers’ anonymized abstracts to bartering partners. Wojcicki has said in an annual for Bloomberg TV that 23andMe makes “a baby margin” on anniversary kit it sells, but it seems absurd that these revenues are abundant to abutment the company’s operating expenses.

Meanwhile, 23andMe has already partnered with pharma aggregation Genentech on a abstraction of the blight biologic Avastin, to acquisition users who accomplish abiding absolution and ascertain if any of the SNPs in 23andMe’s database are responsible. Academic centers and pharmaceutical companies would be actively absorbed in accessing a database of a million genotypes, complete with analysis responses that angle as acceptable proxies for clinical data. 23andMe’s banking solvency may draft in ample allotment on whether it has accumulated abundant genotypes to allure this affectionate of bartering interest.

23andMe doesn’t accumulate these partnerships a secret, and admired allegation adeptness able-bodied appear from them. The aggregation additionally food customers’ claimed advice – names, acquaintance and acquittal advice – alone from its added data, so any advice it shares with ally is anonymous. But alive that their own genotypes, and analysis responses, are 23andMe’s absolute artefact could calmly be a turnoff for customers, and the aggregation absolutely doesn’t go out of its way to advertise this aspect of the business – as a glance over its Analysis Accord Document will attest. 

To be fair, 23andMe barter as a accomplished are acquisitive to participate in research, and absolutely appetite their data acclimated for atypical medical discoveries. Tung is actual agog about how barter accede to the service. “Getting added advice is a relatively failing affair for us, because bodies frequently log aback into their accounts,” she says. She additionally emphasizes that the alternation amid 23andMe and its barter is a two-way street. Analysis participants can advance new questions or changes to the surveys, and Tung’s aggregation tries to accompany the right analysis to the appropriate customers. If she wants to abstraction childbearing, for instance, she’ll ambition surveys to barter of bearing age.

“We absolutely amount our customers’ time,” she adds. “The added we can balloon up to the top the things that are most accordant and absorbing to them, the better.”

But barter may not be acquainted that 23andMe is not the only accumulation administering analysis on their genotypes. Barter anxious about bartering ally application their abstracts do not accept to accord to analysis participation, but those who accept this advantage charge abjure their abstracts from centralized 23andMe analysis as well.

A Authoritative Path 

My aftermost catechism for Tung is whether she thinks the affection of analysis advancing from her administration could influence the FDA’s approaching decisions about direct-to-consumer testing.

“It might,” she says, afterwards a moment. “It might.”

Given her employer’s reluctance to allege about about why the FDA came bottomward adjoin the PGS bloom reports, and what it adeptness booty to accompany them back, I hadn’t hoped for a abundant more accessible answer. Approached for animadversion on the FDA decision, 23andMe offered me this statement: “Our ambition is to assignment cooperatively with the FDA to accommodate consumers with admission to their abiogenetic abstracts in a way that acutely demonstrates the annual of accepting that advice and the science that underlies the test.”  

Like 23andMe’s added accessible responses, it’s both abashed and defiant. Acutely the FDA has never been afraid that 23andMe would abort to communicate the allowances of claimed genetics. At the aforementioned time, the annual does assume to acknowledge, amid the lines, that barter could misunderstand the appearing ascendancy of their accident reports.

Now that the FDA’s jurisdiction over direct-to-consumer analysis has been settled, the catechism is what will amuse the bureau of a test’s reliability. If the FDA is accessible to resume the 510(k) process, we may acquisition the altercation has been abundantly a amount of packaging. A altered way of communicating abiogenetic risk, some aciculate disclaimers about the acting attributes of genomics, and some affirmation that the 23andMe SNP dent is analytically valid, adeptness alpha to bright up apropos that the PGS accomplish over the band into unvalidated diagnoses.

Then again, if the bureau holds close on labeling the PGS a chic III device, it’s difficult to see a way forward. 23andMe would be hard-pressed to bear accurate analytic studies to prove the accurateness of its bloom calls, or that barter won’t be afflicted by their after-effects – both all-important altitude for premarket approval.

Either way, Tung’s administration is demography a attitude of business as usual. Although new genotypes – and possibly alike new analysis responses – accept slowed to a trickle, there’s already affluence of actual to mine. It’s additionally bright that the focus charcoal absolutely on health, behindhand of whether barter are accustomed to see the allegation or not. Before the FDA action, 23andMe fabricated concerted pushes to accompany in barter with Parkinson’s disease, sarcomas, and claret cancers, and analysis projects on these diseases are still underway.

The Parkinson’s activity in accurate is an absorbing effort. 23andMe has genotyped added than 10,000 bodies with the disease, and appear new abiogenetic accident factors. As large abiogenetic databases like this are leveraged against bloom discoveries, the company’s methods accretion new support, and a bloom ambiance that takes into annual abiogenetic accident looks added inevitable. It’s far from affidavit that 23andMe can adumbrate your approaching bloom from a SNP chip, but it does accomplish the attack assume added worthwhile.

As to whether that will affect the FDA’s thinking… It might. It might. 

 

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