23andme stages a come­back

Fast Company - - Contents - By Adam Bluestein

The Dna-test­ing com­pany’s jour­ney back to health is a les­son in learn­ing to adapt.

Anne Wo­j­ci­cki, CEO of the ground­break­ing Dna-test­ing com­pany, got cross­ways with the Fda—and had to re­think ev­ery­thing. It was a bless­ing in dis­guise.

WEAR­ING A BLUE FLEECE JACKET, RUN­NING SHORTS, AND SNEAK­ERS, HER HAIR IN A PONY­TAIL, ANNE WO­J­CI­CKI IS RECOUNTING HER EVENING OUT THE NIGHT BE­FORE. SHE AND A COU­PLE OF FRIENDS HAD GONE TO SEE U2 AT LEVI’S STA­DIUM IN SANTA CLARA (SHE’S FRIENDLY WITH THE BAND), AND WO­J­CI­CKI HAD FOR­GOT­TEN NOT ONLY HER FRIENDS’ TICK­ETS BUT HER OWN AC­CESS BADGE, TOO. SO, SHE SAYS, “WE JUST BUSTED OUR WAY IN.”

Wo­j­ci­cki, sit­ting in a glass con­fer­ence room at the Moun­tain View, Cal­i­for­nia, of­fice of 23andme, the com­pany she co­founded in 2006, seems not to ap­pre­ci­ate the irony of her story. Just four years ear­lier she paid a heavy price for try­ing to bull­doze her way through ob­sta­cles: In Novem­ber 2013, the FDA gave 23andme a force­ful slap-down, bar­ring the com­pany from sell­ing its revo­lu­tion­ary DNA spit test, which had stirred pas­sion­ate in­ter­est and gen­er­ated head­lines for promis­ing to de­moc­ra­tize ge­netic test­ing and yield data-driven cures for dis­ease. (Fast Com­pany had even run a cover story call­ing her “The Most Dar­ing CEO in Amer­ica.”) The FDA de­clared her com­pany’s ser­vice an “un­ap­proved med­i­cal de­vice,” a crip­pling blow.

While 23andme could still sell its an­ces­try prod­uct, Wo­j­ci­cki and her in­vestors—in­clud­ing Google co­founder Sergey Brin (Wo­j­ci­cki’s then-hus­band, who has per­son­ally in­vested in the com­pany), Google it­self (where Anne’s sis­ter Su­san was em­ployee No. 18 and is now CEO of Youtube), and Rus­sian bil­lion­aire Yuri Mil­ner— hadn’t stuck their necks out and put up $118 mil­lion to build a ge­neal­ogy ser­vice. 23andme’s unique value propo­si­tion, and its founders’ mis­sion, was to em­power in­di­vid­u­als with ac­tion­able ge­netic health in­for­ma­tion. Sud­denly all that po­ten­tial was in doubt.

How 23andme turned that un­cer­tainty around—and, in fact, ex­panded its brand—is a tale of per­se­ver­ance, adapt­abil­ity, and what in days gone by might have been called gump­tion. Less than a year af­ter the FDA’S re­buke, for in­stance, Wo­j­ci­cki signed a lease on a new, larger of­fice space, even though it wasn’t clear at that time if the com­pany would sur­vive. A glass hive with a rooftop gar­den and free lunch and snacks for the nearly 300 em­ploy­ees, the space sports re­minders of what the com­pany has al­ready over­come. A green couch sits in a com­mon seat­ing area, one of a crop of hand-me-downs from Wo­j­ci­cki’s first apart­ment in New York. “We’ve been re­ally fru­gal,” she says. “We used to pride our­selves on these $19 Ikea chairs that would break if you weighed over 220 pounds. We would

go visit com­peti­tors in the early days and say, ‘Oh, they’ve got fancy chairs—they’re burn­ing cash.’ ”

To­day, 23andme is back on track and, as Wo­j­ci­cki puts it, “I still want more.” In April, the com­pany re­ceived FDA con­sent to re­store some of its health re­ports, no­tably those that as­sess a cus­tomer’s ge­netic risk of de­vel­op­ing Parkinson’s and late-on­set Alzheimer’s. Be­yond this “ma­jor ac­com­plish­ment,” as Wo­j­ci­cki de­scribes it, the com­pany has also forged large-scale part­ner­ships with busi­nesses such as Ge­nen­tech, Proc­ter & Gam­ble, and Tar­get; launched an in-house drug-devel­op­ment pro­gram; and raised $155 mil­lion in a Se­ries E round, el­e­vat­ing its val­u­a­tion to an es­ti­mated $1.1 bil­lion.

Still, the cur­rent ver­sion of 23andme’s prod­uct of­fers only a frac­tion of the 254 re­ports it fea­tured in 2013. And while the com­pany now boasts what Wo­j­ci­cki calls “a great, very sup­port­ive re­la­tion­ship” with the FDA, get­ting the next set of ap­provals—for re­ports on can­cer risk and drug re­sponse—is hardly as­sured. Mean­while, com­peti­tors such as An­ces­try and Helix have sug­gested they may start of­fer­ing their own health re­ports (An­ces­try has filed for an IPO), and un­cer­tainty over ge­netic pri­vacy is­sues con­tin­ues to loom over the sec­tor.

Yet con­sid­er­ing all the drama and set­backs, Wo­j­ci­cki might be for­given a bit of se­lec­tive en­thu­si­asm. Build­ing a cult brand within the staid, highly reg­u­lated health in­dus­try is un­usual; sus­tain­ing users’ and in­vestors’ in­ter­est through years of con­tro­versy ratch­ets up the chal­lenge fur­ther. How Wo­j­ci­cki has man­aged 23andme’s come­back, and what she has planned next, is a play­book for dis­rup­tion. As she re­calls, when she first heard about the FDA clam­p­down, “I was like, ‘Hey, what can we do in six weeks [to fix this]?’ I learned pretty quickly, like, noth­ing. I’ve learned that things take longer than you ex­pect.”

Wo­j­ci­cki re­ceived a BS in bi­ol­ogy from Yale

be­fore go­ing to work as a biotech an­a­lyst with a New York hedge fund in the late ’90s, ex­pe­ri­ences that helped her ap­pre­ci­ate not only the enor­mous pub­lic-health op­por­tu­ni­ties that would be cre­ated by the Hu­man Genome Project, but also the in­ef­fi­cien­cies of a health care sys­tem where it seemed every­body but the con­sumer got to call the shots. This is what mo­ti­vated her to start 23andme. When the com­pany be­gan of­fer­ing its Per­sonal Genome Ser­vice (PGS), in 2007, there was no prece­dent. Ge­netic screen­ing for a panel of in­her­i­ta­ble con­di­tions was rou­tinely of­fered by doc­tors to would-be par­ents, to as­sess their like­li­hood of pass­ing on harm­ful mu­ta­tions to their off­spring. And Myr­iad Ge­net­ics had a doc­tor­ad­min­is­tered test with a list price of more than $3,000 that de­tected ge­netic mu­ta­tions as­so­ci­ated with in­creased risk of breast and ovar­ian can­cer, lead­ing some women (fa­mously, ac­tress An­gelina Jolie) to seek mas­tec­tomies and/or ovary re­moval. These tests had to be pre­scribed by doc­tors and were of­ten in­ter­preted by ge­netic coun­selors.

23andme was do­ing some­thing quite dif­fer­ent, lever­ag­ing tech­ni­cal ad­vances in ge­nomic

se­quenc­ing, and dras­ti­cally fall­ing prices, to of­fer ex­ten­sive DNA anal­y­sis di­rectly to con­sumers. An­a­lysts and re­porters cov­er­ing the com­pany fre­quently de­scribed 23andme’s busi­ness model of by­pass­ing the med­i­cal es­tab­lish­ment as hubris, a case of brash Sil­i­con Val­ley con­fronting slug­gish con­ven­tion. Wo­j­ci­cki pushes back at any sug­ges­tion that the com­pany was in­clined to side­step reg­u­la­tors. When 23andme launched its first health re­port to con­sumers, she notes, it had CLIA (Clin­i­cal Lab­o­ra­tory Im­prove­ment Amend­ments) ap­proval, the usual stan­dard for di­ag­nos­tic tests that are han­dled through a sin­gle-lab fa­cil­ity. Wo­j­ci­cki says she didn’t con­sider 23andme’s test to fall un­der the FDA’S purview at first, in part be­cause they weren’t di­ag­nos­ing dis­eases, just re­port­ing risks. “An APOE mu­ta­tion isn’t di­ag­nos­ing you with Alzheimer’s,” she says. “It’s a risk fac­tor.” But as doc­tors, ge­neti­cists, and state reg­u­la­tors started to ques­tion the re­li­a­bil­ity and ap­pro­pri­ate­ness of 23andme’s tests, the com­pany saw where things were headed and in 2008 started meet­ing reg­u­larly with the FDA about a pos­si­ble path to ap­proval by the agency. “We had some hu­mil­ity,” says Wo­j­ci­cki. “We did show up.”

There seemed to be lit­tle sense of ur­gency on the FDA’S part, un­til June 2010—shortly af­ter 23andme started sell­ing its kit through Ama­zon—when the FDA sent warning let­ters to the com­pany, along with di­rect-to-con­sumer ge­nomics com­peti­tors Nav­i­gen­ics, de­code, Knome, and Il­lu­mina. (Another com­pany, Path­way, had re­ceived a let­ter in May, four days be­fore it planned to start sell­ing its test in Wal­greens.) “You should take prompt ac­tion to re­spond to this let­ter,” wrote Al­berto Gu­tier­rez, the direc­tor of the FDA’S of­fice of in vitro di­ag­nos­tic de­vice eval­u­a­tion and safety. Ac­cord­ing to Gu­tier­rez, 23andme’s Per­sonal Genome Ser­vice didn’t meet the cri­te­ria for a sin­gle-lab test, and be­cause con­sumers might make im­por­tant med­i­cal de­ci­sions based on the in­for­ma­tion it con­tained, it was a di­ag­nos­tic “de­vice” un­der the Fed­eral Food, Drug, and Cos­metic Act.

The com­pany found it­self in new ter­ri­tory. While it was al­lowed to keep sell­ing the test, it faced fresh scru­tiny. For the next two and a half years, rep­re­sen­ta­tives from 23andme and the FDA had “14 face-to-face and tele­con­fer­ence meet­ings, hun­dreds of email ex­changes, and dozens of writ­ten com­mu­ni­ca­tions,” ac­cord­ing to the FDA. 23andme sub­mit­ted its first ap­pli­ca­tion for FDA clear­ance in July 2012—un­suc­cess­fully—and fol­lowed it with another sub­mis­sion at the be­gin­ning of Septem­ber. Into 2013, the record shows ex­ten­sive back and forth as 23andme at­tempted to re­spond to FDA feed­back and re­quests for ad­di­tional ev­i­dence.

Then, in May 2013, 23andme abruptly went quiet, which didn’t sit well with the FDA. A com­pany spokesper­son ex­plains that “the de­lays on our part re­ally were re­lated to mis­com­mu­ni­ca­tion and lack of un­der­stand­ing the process.” This quiet stretch with reg­u­la­tors co­in­cided with a nois­ier pub­lic pos­ture, punc­tu­ated by the launch of new 23andme TV ads. This ex­panded brand­ing ef­fort seemed to trip some sort of in­vis­i­ble wire at the FDA. Af­ter hear­ing noth­ing of­fi­cial from 23andme for six months, the FDA sent a heated shut-down let­ter scold­ing 23andme for fail­ing to sub­mit ev­i­dence that its re­ports could be trusted. “We have been dili­gently work­ing to help you com­ply with reg­u­la­tory re­quire­ments,” this new let­ter from Gu­tier­rez read. “FDA has not re­ceived any com­mu­ni­ca­tion from 23andme since May. In­stead, we have be­come aware that you have ini­ti­ated new mar­ket­ing cam­paigns, in­clud­ing tele­vi­sion com­mer­cials that, to­gether with an in­creas­ing list of in­di­ca­tions, show that you plan to ex­pand the PGS’S uses and con­sumer base with­out ob­tain­ing mar­ket­ing au­tho­riza­tion from FDA.”

Wo­j­ci­cki turns re­flec­tive when re­call­ing the let­ter. “With­out a doubt, we didn’t have the right team in place or the ex­pe­ri­ence in how to get reg­u­lated,” says Wo­j­ci­cki. “More and more, I’ve learned how far off we were.” 23andme was forced to stop sell­ing its health re­ports im­me­di­ately.

“Change what you can; man­age what you

can’t,” reads the tagline for a 23andme ad cam­paign from around this time, ad­vice that Wo­j­ci­cki and Andy Page, a for­mer pres­i­dent of Gilt Groupe who came on as 23andme pres­i­dent just months be­fore the 2013 let­ter ar­rived, took to heart. “It was a huge wind out of our sails,” says a for­mer em­ployee who was there dur­ing the cri­sis.

In the weeks af­ter re­ceiv­ing the let­ter, 23andme is­sued press re­leases declar­ing its in­ten­tion to con­tinue mar­ket­ing parts of its ser­vice that the FDA didn’t ex­plic­itly for­bid—in­for­ma­tion about an­ces­try and “raw ge­netic data with­out in­ter­pre­ta­tion”—and pledg­ing to keep work­ing with the FDA to re­store the full range of health tests.

To that end, Wo­j­ci­cki hired a reg­u­la­tory af­fairs ex­pert, Kathy Hibbs, an at­tor­ney who had been work­ing at Ge­nomic Health, a can­cer ge­nomics com­pany. Hibbs had been in­tro­duced to Wo­j­ci­cki by a mu­tual friend and only agreed to meet as a fa­vor. “It didn’t oc­cur to me that they’d re­cruit me,” she says, “and it didn’t oc­cur to me that I’d be in­ter­ested.” But she felt that the com­pany’s in­ter­ac­tion with the FDA “had the po­ten­tial to es­tab­lish the stan­dards for sim­i­lar prod­ucts in the fu­ture. That’s a pow­er­ful thing, and it’s an ac­tual ad­van­tage.” The FDA’S warning let­ter “was pretty provoca­tive,” she ad­mits, but “I don’t think they were try­ing to kill the com­pany.”

But it would take time—and luck—as well as bet­ter sci­ence to re­pair 23andme’s trust with the FDA. Hibbs has tack­led the process in chunks, iden­ti­fy­ing those ar­eas with the high­est like­li­hood of ap­proval first, and then mov­ing to the more touchy ones, in­clud­ing the tests for BRCA gene mu­ta­tions and drug re­sponse (such as sen­si­tiv­ity to the blood thin­ner war­farin).

In the mean­time, the com­pany had no choice but to shift its mar­ket­ing to fo­cus on its an­ces­try prod­uct. The FDA’S warning let­ter gave the

“WITHOUTADOUBT,WEDIDN’T HAVETHERIGHTTEAMINPLACEOR THEEXPERIENCEINHOWTOGET REG­U­LATED,”SAYSWOJCICKI. “MOREANDMORE,I‘VELEARNED HOWFAROFFWEWERE.”

com­pany im­pe­tus to ex­plore the more whim­si­cal side of its busi­ness, such as find­ing rel­a­tives you never knew about. This rel­a­tively low-cost con­sumer DNA test turned out to be a shock­ingly ef­fec­tive way to cre­ate a ge­netic data­base the likes of which no other pub­lic or pri­vate en­tity has ever seen. Sell­ing the $99 an­ces­try re­ports alone, the com­pany added more than half a mil­lion new cus­tomers be­tween De­cem­ber 2013 and June 2015, when it an­nounced its 1 mil­lionth geno­typed cus­tomer. To­day, the com­pany has col­lected DNA from more than 2 mil­lion peo­ple.

Thanks to this un­ex­pected ap­peal, 23andme now con­trols the world’s largest and most di­verse col­lec­tion of hu­man geno­types (600,000-plus unique ge­netic mark­ers per in­di­vid­ual) paired with self-re­ported phe­no­typic in­for­ma­tion (hun­dreds of data points per av­er­age in­di­vid­ual on traits rang­ing from lac­tose in­tol­er­ance to male pat­tern bald­ness to a fam­ily his­tory of can­cer). More than 80% of 23andme cus­tomers—even those who just pur­chase the an­ces­try prod­uct— opt in to its re­search pro­gram, al­low­ing the com­pany to share its anonymized data with aca­demic and in­dus­try part­ners. The in­for­ma­tion, in turn, has al­lowed sci­en­tists to run gene-as­so­ci­a­tion stud­ies—trawl­ing through huge amounts of data to find mu­ta­tions that are strongly linked to par­tic­u­lar traits or health con­di­tions. Plus, be­cause 23andme does an ex­cep­tional job at keep­ing cus­tomers en­gaged well be­yond get­ting their test re­sults—the com­pany pushes fre­quent updates on ge­netic re­search, a com­bi­na­tion of se­ri­ous med­i­cal re­search as well as cock­tail­party-friendly stud­ies on the ge­net­ics of cilantro aver­sion or the ten­dency to be a “morn­ing per­son”—it can prompt them to fill out an end­less string of sur­veys. “The core el­e­ment of our com­pany is this part­ner­ship with the cus­tomer,” says Wo­j­ci­cki.

If a drug com­pany wants to study Parkinson’s, for ex­am­ple, it can quickly iden­tify some 15,000 peo­ple with the con­di­tion through 23andme—or nearly 300,000 with de­pres­sion or high blood pres­sure—and ask them to com­plete ad­di­tional sur­veys, re­cruit them to par­tic­i­pate in clin­i­cal tri­als or ad­di­tional kinds of tests, or per­haps, one day, con­tact them about a new treat­ment.

Re­searchers work­ing with 23andme’s data have al­ready started to pub­lish break­through find­ings. A project with the Michael J. Fox Foun­da­tion has iden­ti­fied novel biomark­ers for Parkinson’s dis­ease. One with Pfizer de­tected 15 new re­gions of the hu­man genome linked to a higher risk of se­ri­ous de­pres­sion. Ge­nen­tech paid a re­ported $10 mil­lion up front (with a po­ten­tial $50 mil­lion more for hit­ting key mile­stones) to ac­cess ge­nomic data from 23andme’s Parkinson’s com­mu­nity. These sorts of suc­cesses have at­tracted other part­ners. Proc­ter & Gam­ble is us­ing ge­netic in­sights gleaned from 23andme to help in­form its mar­ket­ing of prod­ucts rang­ing from over-the-counter sleep aids to skin creams, steer­ing peo­ple whose ge­netic pro­file sug­gests they’d be un­re­spon­sive to retinol, for ex­am­ple, to al­ter­na­tive an­ti­ag­ing prod­ucts. “We can go in the di­rec­tion of per­son­al­ized skin care,” says Frauke Neuser, a prin­ci­pal sci­en­tist at P&G’S Olay brand.

23andme’s head of busi­ness devel­op­ment, Emily Dra­bant Con­ley, says that “in the early days it was all up­hill. It was hard. Now there’s this re­al­iza­tion that hu­man ge­netic data is valu­able. It feels like we’re in a dif­fer­ent time pe­riod.”

If sell­ing test kits to con­sumers rep­re­sents 23andme’s cen­tral busi­ness, and forg­ing

data-shar­ing part­ner­ships with com­pa­nies is its pri­mary line ex­ten­sion, then the com­pany’s in-house ther­a­peu­tics-devel­op­ment di­vi­sion could be con­sid­ered its moon­shot. Cre­at­ing a drug may be the ut­most em­bod­i­ment of Wo­j­ci­cki’s mis­sion to trans­mute data into real im­prove­ments in pub­lic health. “It’s our re­spon­si­bil­ity to help peo­ple fig­ure out how to pre­vent de­vel­op­ing a dis­ease, or to find a cure for it,” she says. “In sci­ence, the best way to try to drive change is to lead by ex­am­ple. If I re­ally be­lieve—and I do—that start­ing with hu­man ge­netic data will make the drug dis­cov­ery process faster and more ef­fec­tive, then the best way to prove that is to do it.”

Richard Scheller al­ways saw the po­ten­tial for drug devel­op­ment in 23andme’s data­base. The award-win­ning bio­chemist, who had spent 14 years lead­ing re­search strat­egy, drug dis­cov­ery, busi­ness devel­op­ment, and early-stage drug-devel­op­ment ac­tiv­i­ties at Ge­nen­tech, had played a key role in Ge­nen­tech’s in­vest­ment in 23andme’s 2007 Se­ries A. Per­son­ally, he says, “up un­til I started, the data­base wasn’t large enough to be re­ally ex­cit­ing for me. But it got there, and now with the FDA ap­provals and more so­phis­ti­cated mar­ket­ing, it’s grow­ing in­cred­i­bly fast.”

The walls are blind­ingly white at 23andme’s re­search lab in South San Fran­cisco, and the cen­trifuges, mass spec­trom­e­ters, and lab­o­ra­tory re­frig­er­a­tors still gleam like new. Scheller, dressed in a check­ered flan­nel shirt and droop­ing gray jeans, leads a tour of the fa­cil­ity, sip­ping Diet Coke from a cup. For the past two years he has been over­see­ing a team that has grown to more than 30 sci­en­tists, hop­ing to use 23andme’s data­base to al­ter the eco­nom­ics of bring­ing new drugs suc­cess­fully to mar­ket. On av­er­age, a new drug costs more than a bil­lion dol­lars to de­velop. This is be­cause for ev­ery one that works, 10 don’t. Drugs with a ba­sis in hu­man ge­net­ics, though, have a suc­cess rate one-and-a-half-fold to twofold higher, says Scheller. “If we can be even twice as good as the in­dus­try av­er­age, we would be in pretty good shape.”

Scheller is cur­rently fo­cus­ing on sev­eral con­di­tions, in­clud­ing car­dio­vas­cu­lar and liver dis­ease, can­cer, skin dis­eases, and im­muno­log­i­cal disor­ders. “We want to bias our­selves to some­thing that’s go­ing to work,” he says. That means leav­ing the devel­op­ment of neu­ro­log­i­cal drugs—scheller’s spe­cialty—to part­ners. “The most im­por­tant thing for a young com­pany is to be suc­cess­ful, and dis­eases of the brain are hard. That’s not a place to start.”

THEFDA’SWARNINGLETTER TO23ANDME“WASPRETTY PROVOCA­TIVE,”SAYSREGULATORY AFFAIRSHEADHIBBS,BUT“I DON’TTHINKTHEYWERETRYING TOKILLTHECOMPANY.”

If the com­pany hap­pens upon a drug com­pound that works, 23andme would likely sell or li­cense the mar­ket­ing rights to a part­ner. “What pharma com­pa­nies do re­ally well is run­ning clin­i­cal tri­als and mar­ket­ing,” says Wo­j­ci­cki. “Those are re­ally com­pli­cated and ex­pen­sive things to do. Where we can po­ten­tially be re­ally good is on the dis­cov­ery side.” Her goal is to get a new drug to the point where it’s proven ef­fec­tive in hu­mans.

Even in the rosiest sce­nario, it will be years

be­fore Scheller’s team sees any big com­mer­cial re­ward for its ef­forts. In the mean­time, 23andme ex­pects to con­tinue work­ing with the FDA to ex­pand its menu of di­rect-to-con­sumer health tests. The com­pany is on much bet­ter terms now with the agency reg­u­lat­ing it. “I think they’re re­ally proud of the work they did,” says Hibbs of the FDA. “It gives them the abil­ity to em­brace in­no­va­tion.” FDA spokesper­son Tara Goodin says via email that “since 2013, 23andme has dili­gently col­lab­o­rated with the FDA to cre­ate a model for of­fer­ing a ge­netic health risk test di­rectly to con­sumers that mit­i­gates risks as­so­ci­ated with how a con­sumer in­ter­prets and uses the test re­sults.” Of course, the fact that every­one’s play­ing nicely now doesn’t mean that fu­ture ap­provals the com­pany is seek­ing— for can­cer risk and drug re­sponse, po­ten­tially the most ac­tion­able in­for­ma­tion for con­sumers—will be any eas­ier to win.

One of the re­ports that Wo­j­ci­cki badly wants back is for mu­ta­tions in the BRCA1 and BRCA2 genes, which are highly pre­dic­tive for breast and ovar­ian can­cer. The tests are not only po­ten­tially life­sav­ing but lu­cra­tive:

The No. 1 provider of BRCA test­ing,

Myr­iad Ge­net­ics, earns some $632 mil­lion an­nu­ally from its ser­vices. But Wo­j­ci­cki will face head­winds—in part be­cause of her own de­ci­sions. 23andme has cho­sen to forgo us­ing so-called next-gen­er­a­tion se­quenc­ing (NGS) tech­nol­ogy for now, since it is ex­pen­sive and re­sults can be hard to in­ter­pret. Un­like Myr­iad’s NGS test, 23andme’s is de­signed to screen only for the three most com­mon BRCA vari­ants found among Ashke­nazi Jews, among whom the in­ci­dence of BRCA mu­ta­tions is about 1 in 40, ver­sus about 1 in 400 in the gen­eral pop­u­la­tion.

“When 23andme cus­tomers got a pos­i­tive BRCA re­sult, it was a pos­i­tive,” says Jill Ha­gen- kord, who led a next-gen­er­a­tion se­quenc­ing ef­fort at 23andme from 2014 to 2016 and is now chief med­i­cal of­fi­cer at Color Ge­nomics—whose $249 doc­tor-or­dered test uses NGS to screen for sev­eral hered­i­tary can­cer risk fac­tors. But when it was neg­a­tive? “There’s a con­cern about peo­ple who think they got a BRCA test but re­ally didn’t,” Ha­genkord says.

Opt­ing not to use NGS will also limit the types of drug dis­cov­ery that the com­pany will be able to do, says Scott Heb­bring, a re­search sci­en­tist at the Cen­ter for Hu­man Ge­net­ics at Marsh­field Clinic Re­search In­sti­tute in Wis­con­sin. “Hav­ing just the com­mon vari­ants from geno­typ­ing,” he says, “can make it harder to find vari­a­tions with large ef­fects that could be rare but po­ten­tially the most in­ter­est­ing for un­der­stand­ing dis­ease.”

23andme also faces pri­vacy fears, which have only in­creased since Wo­j­ci­cki launched her com­pany a decade ago. “We’re liv­ing in a time when we can no longer be com­pletely san­guine about the safety of any of the data we share with the world,” says Misha An­grist, an as­so­ci­ate pro­fes­sor in the So­cial Sci­ence Re­search In­sti­tute at Duke Uni­ver­sity. “We’ve seen too many re­ports of For­tune 500 com­pa­nies, to say noth­ing of hos­pi­tals, get­ting hacked.”

The Ge­netic In­for­ma­tion Nondis­crim­i­na­tion Act of 2008 (GINA), which pro­tects in­di­vid­u­als from ge­netic dis­crim­i­na­tion in health in­sur­ance and em­ploy­ment, was “a good start” on reg­u­lat­ing the le­git­i­mate uses of ge­netic data, says Heb­bring. “But it’s by no means com­pre­hen­sive.” It doesn’t ap­ply to mil­i­tary per­son­nel or em­ploy­ees of com­pa­nies with fewer than 15 work­ers, and GINA will not pro­tect con­sumers with known ge­netic con­di­tions from be­ing dis­crim­i­nated against for dis­abil­ity in­sur­ance, long-term-care in­sur­ance, and life in­sur­ance. (In those in­dus­tries, car­ri­ers are ex­press­ing new con­cerns about con­sumers who game the sys­tem by buy­ing long-term-care cov­er­age only when they dis­cover—but don’t dis­close—an in­creased ge­netic risk for Alzheimer’s.) If the Af­ford­able Care Act is re­pealed, its ex­plicit pro­hi­bi­tion against dis­crim­i­na­tion for pre­ex­ist­ing con­di­tions, in­clud­ing ones re­vealed through ge­netic test­ing, could be weak­ened in sig­nif­i­cant ways. The re­al­ity, or even just the per­cep­tion, that your DNA could be used against you could have a chill­ing ef­fect on peo­ple’s will­ing­ness to get ge­netic test­ing for any pur­pose.

All of this makes it cru­cial for 23andme to po­si­tion it­self as an ap­proach­able and ac­ces­si­ble brand. “I think there’s a whole world of peo­ple who don’t get any health care be­cause it’s too cum­ber­some and ex­pen­sive,” Wo­j­ci­cki says. That’s why she “loves” Wal­mart’s $59 nurse prac­ti­tioner visit and CVS’S Min­ute­clinic. The de­sire to con­nect with con­sumers in the real world, out­side the health care bub­ble, is what pushed her to get main­stream re­tail­ers—in­clud­ing CVS, Sam’s Club, and Tar­get—to start car­ry­ing 23andme’s health-and-an­ces­try test over the past year and per­suade Ama­zon to start sell­ing it again. It also helped mo­ti­vate her to cap­ture the pop­u­lar imag­i­na­tion through part­ner­ships that wouldn’t have been imag­in­able when the com­pany started out, like the re­cent mar­ket­ing cam­paign with Uni­ver­sal Pic­tures around the re­lease of De­spi­ca­ble Me 3, fea­tur­ing an an­i­mated short in which the char­ac­ter Gru dis­cov­ers a lon­glost brother us­ing 23andme’s DNA Rel­a­tives tool.

“We’re def­i­nitely a mis­sion-driven com­pany,” Wo­j­ci­cki says. “There’s a lot of skep­ti­cism about that, but we re­ally want to drive pos­i­tive change in health care.” Many would-be dis­rupters in Sil­i­con Val­ley talk about chang­ing the world. But do­ing so takes both skill and stamina. “In some ways, what hap­pened with the FDA has forced me to learn the les­son of pa­tience,” says Wo­j­ci­cki. “Ev­ery­thing is in steps.”

“INSCIENCE,THEBESTWAY TODRIVECHANGEISTOLEADBY EX­AM­PLE,”WOJCICKISAYS.

Kathy Hibbs, who leads reg­u­la­tory af­fairs for 23andme, has worked strate­gi­cally to gain FDA ap­proval.

Emily Dra­bant Con­ley, the com­pany’s head of busi­ness devel­op­ment, says that she has seen a huge uptick in part­ner­ship in­ter­est.

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