30 Jun Microbiology Discussion
FEB. 19, 2015 New York Times Business Day F.D.A. Reverses Course on 23andMe DNA Test in Move to Ease Restrictions By ANDREW POLLACK Anne Wojcicki, chief of 23andme, which won approval of a genetic test for Bloom syndrome. Credit Peter DaSilva for The New York Times The genetic testing company 23andMe on Thursday took a step toward being able to offer consumers health-related information again, winning approval from the Food and Drug Administration for a test for mutations that cause a rare disease. The company, a pioneer in offering genetic tests direct to consumers from a sample of spit, stopped doing health-related testing in late 2013 after the F.D.A., in a scathing warning letter, said that such tests required the agency’s approval before they could be marketed. 23andMe had been operating under the principle that consumers had the right to get information from their own DNA. On Thursday, the F.D.A. approved a test from 23andMe that would be administered to prospective parents to see if they carry mutations that could cause a rare disorder called Bloom syndrome in their children. The agency also said that, in general, such so-called carrier tests would no longer need to be approved in advance before being marketed. It also voiced support for allowing consumers in some situations to have direct access to genetic testing, without a doctor being involved. “The F.D.A. believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” Alberto Gutierrez, director of the regulator’s office in charge of diagnostic tests, said in a statement. Anne Wojcicki, the chief executive of 23andMe, said the approval was a first step for her company and the government. “It shows the F.D.A. is willing and supportive of crafting the direct-to-consumer path,” she said in an interview. “It’s a very reasonable first step. I would go so far as saying it’s a very generous first step.” She said that she believed it was the first time that the F.D.A. had approved a genetic test to be offered directly to consumers. There are other types of tests, like pregnancy tests, that are sold directly to consumers. Ms. Wojcicki declined to say when 23andMe would start offering health information again, but said it would probably be this year. However, it would most likely be limited to a suite of carrier tests. “We want to be back on the market with meaningful information as soon as possible,” she said. The company was most known for giving customers information about their risk of getting various diseases. Executives said those tests would take more time to gain approval. But having achieved approval of one test, they said, the company now better understood what it would need to do to win clearance of other tests. The company, based in Silicon Valley and financially backed by Google, says more than 850,000 people have used its service, which costs $99. After it stopped providing health-related information, it continued to offer ancestry information. It is also offering drug companies and others access to its data for research, signing deals with Pfizer and Genentech. Carrier tests are for diseases — cystic fibrosis being the most well known — in which two copies of an abnormal gene, one from the father and one from the mother, are necessary for someone to be sick. People with one normal copy and one abnormal copy are carriers and generally healthy. But if two carriers mate, their children have a chance of inheriting two abnormal copies and getting the disease. Bloom syndrome is characterized by short stature, skin redness, distinctive facial features and increased susceptibility to cancer. Many people with the rare condition are Ashkenazi Jews. Ms. Wojcicki said she was a carrier for that disease. To gain approval of its Bloom syndrome test, 23andMe conducted two studies demonstrating that it could accurately detect carrier status. It did other studies demonstrating that consumers could follow directions for providing saliva samples and understand the results of the test. HealtH Code Breaker Anne Wojcicki has clashed with the FDA in her quest to reveal the secrets of your DNA. But this tech tabloid fgure may also be revolutionizing the way we approach health in the information age. by Dr. Peter b. bach well wishers S he has endured gossip as the most famous jilted spouse in Silicon Valley and been idolized as America’s most daring CEO, but the proper title for anne Wojcicki is DNA safecracker. She’s opening the vault that keeps information about you fom you, starting with your genetic code. Sure, the 41-year-old frst landed in the headlines as Google co-founder Sergey Brin’s other half, but it’s as the co-founder of the genetic testing company 23andMe that Wojcicki (pronounced Woe-JIT-ski) has become a harbinger of the future of healthcare. When 23andMe launched in 2006, with hefy backing fom Google, its mission was clear: Give individuals direct access to their genetic makeup and explain what that information may predict about their future health so they can make proactive choices about their march 2015 care. Competitors came and went; 23andMe seemed destined to dominate a feld it had practically invented. But then the FDA shut down most of the operation in late 2013, in part because the agency believes potentially fightening test results should be disclosed only under doctor supervision, not directly to a consumer. “I’ve never shied away fom the fact that we generate information that may be lifechanging,” Wojcicki says. “You might fnd out that your father is not your father, and you have a sibling that you don’t know about. And if I can tell you that you are also at higher risk for melanoma, that might send you to get your skin checked.” She is adamant that patients are smarter than they’re given credit for being, and she believes that “people can crowd-source solutions” for themselves. Before 23andMe was curtailed, the company’s test, called the Personal T&C 124 Genome Service, was available for only $99. Te pitch was simple: You send in spit; you get an e-mail that contains a link to detailed information about your genes: what you inherited fom your parents, what your ancestry might be, what diseases you might be at risk for. Now you can still get ancestry analysis and raw genetic data, minus the health indicators. (Citizens of Canada and the U.K. recently gained access to the original test for about $200.) Te medical establishment has yet to come around to 23andMe’s DIY approach to wellness. Wojcicki laughs as she relays a conversation she had with a dermatologist, who said (bro to bro, apparently), “Dude, stop sending people to get their skin checked. Do you know how much I get paid for that? Do you know how much more money I make when I do Botox?” It’s exchanges like this that convince townandcountrymag.com S p e n c e r low e l l / T r u n k A r c h i v e Anne Wojcicki envisions a future in which we crowd-source the solutions to our personal health. HEALTH Wojcicki that the current healthcare model genes are arrayed in each of our cells into 46 one gene at a time. But with the scarcity of data needs to change, even if physicians might separate strands called chromosomes, which are available to us today, it’s a little like trying to remain outside the equation. organized into 23 pairs—the 23 of the company’s fgure out if someone has a good poker hand Even though I’m a doctor, I’ll admit there are name—each of which contains a chromosome when only a couple of her cards are showing. times when it doesn’t make sense to put us in fom each of our biological parents. When it’s It’s a lot of educated guesswork. the middle, where we are ofen no more than our turn we pass on one chromosome fom each Tat was another objection fom the FDA, rushed messengers. Especially not these days, pair to our ofspring. Most of these genes are like which considered some of the connections that when it’s possible for a patient to already be distant stars in the galaxy: We don’t know much 23andMe provided overconfdent, and potenarmed with quite a lot of information about about them, but we are slowly fnding out. We tially wrong. In its letter to the company telling themselves, thanks to wearable technology that now know, for example, that a mutation (which it to stop selling its genetic interpretations to can track activity, sleep, and calorie intake. Angelina Jolie carries) in the BRCA gene indicates customers, the agency said that “serious conWojcicki, who feely calls herself dude as an increased risk of both breast and ovarian cerns are raised if test results are not adequately well, is speaking to me in a conference room in cancer. Other mutations can lead to an increased understood by patients or if incorrect test 23andMe’s one-story ofce building in Mounlikelihood of getting the fatal neurological condi- results are reported.” A spokesman for the tain View, California, literally in the shadow tion called Huntington’s disease, or of manageable FDA told me that there are also “no guidelines of Google’s headquarters. In true Silicon Valley health issues like high blood pressure. for healthcare professionals on how to use style, one quarter of the foor is lef open for Tere is a long list of genes we think are corthese test results.” company CrossFit classes, half of the workstarelated to serious diseases, but we don’t underWojcicki agrees that there is still much to tions are standing desks, and there are few stand how or why. Many may be caused by learn. And then she says something that shows actual ofces, even for the CEO. Wojcicki has multiple genes working together; some combina- that her DNA is all Silicon Valley: what we just fnished Facetiming with her six-year-old tions make you sick, and some don’t. don’t know today data will answer tomorrow. son, who is on his way back fom camp. (She To help interpret the range of genetic diferShe imagines the day we learn about genes and also has a three-year-old daughter.) During ences the company was fnding in its customtheir efects the same way Google learns fom our conversation, texts fom Brin interrupt ers, 23andMe eventually started relying on people searching the web. Google’s searches get us several times. Tough the couple are not something called genome-wide association stud- smarter by generating data and observing how divorced, they now live apart—and have since ies, which search for patterns across a person’s searchers respond. If Wojcicki could gather the the Google co-founder became romantically entire genetic makeup rather than looking at genetic and health information of, say, a few entangled with a 27-year-old million people, she could fnd employee. Wojcicki says that the same kinds of connections. Wojcicki imagines the day we learn about they’re active co-parents in the Afer all, the way researchgenes and their efects the same way Google midst of what appears to be a ers recently discovered a gene pretty amicable breakup. found mostly in Latina women learns fom people searching the web. Te seeds for 23andMe were that protects against breast canplanted when Wojcicki worked cer was by analyzing data fom at an investment fund on Wall about 11,000 women. Street. She jokingly says she For now, amid all the red lef New York to return to the tape, Wojcicki is trying to Bay Area, where she grew up, wedge the door back open with because she couldn’t face one the FDA. Tough I’m the one more meeting in a strip club. who went to med school, she But in truth she had been evaluknows far more about genetating and investing in healthics than I do. My training in care and biotech companies and the subject (which was fairly fgured it was time to turn the standard) consisted of a few whole thing on its head. “I was lectures I half slept through in really fustrated with how conthe early 1990s, a decade before sumers were treated in healththe frst human genome was care,” she says. “Tey don’t fully sequenced. So it’s sort of really get that much choice.” a paradox that the FDA trusts Her goal, she says, has always my kind, and not hers, to combeen to give it back to them. municate genetic information. To do that she and coWojcicki is now trying to founder Linda Avey decided to get approval to give test Sample Size At the 23andMe lab in help people unlock their own results and the accompanying Mountain View, California, genetic codes. Each of us has interpretation for one genetic a technician prepares to about 20,000 genes that make defect in particular. It’s called conduct a genetic profle. [ c o n t i n u e d o n pa g e 2 0 0 ] up our individual DNA. Tose MARCH 2015 T&C 126 townandcountrymag.com S p e n c e r Low e L L / T r u n k A r c h i v e Looking gLass A Model T price and quality had just about no relationship. We gave ample time to each shirt that met the criteria. Oscar and I tried it on, critiqued it, and then read the label. We started with a number of shirts that were, simply, all wrong: billowing, sleeves too short, no oomph. Oscar fnally put on one he really loved—for its proportions, sofness, and ft. I tried it and felt the same way, and Saphora concurred. It was fom Gap. In all cases, and I fnd this surprising given the diferences in physique, what looked good on him looked good on me and what looked silly looked silly (n.b., I am talking about the shirts, not their wearers). One shirt that I tried on and instantly ruled out, as did Saphora, made me look like a dentist at work; Oscar’s take when he put it on was that there was “something medical about it.” To my surprise it was fom Sunspel, a maker whose shirts I had specifcally requested. Sunspel is an elite English manufacturer, and I had seen an ad for its T-shirts, which cost more than $100 each, and a description of the cotton, making me think its would be top-of-theline. Later on in the testing we tried another Sunspel, in a thicker cotton, with a pocket, and it was superb. So I must say, in defense of the company, which uses Sea Island cotton woven in Switzerland for T-shirts made in Derbyshire, that I assume that the no-go was an undershirt, while the dashing one was the only one meant for show. A company neither of us had heard of, American Giant, provided the real thing: the sleeves not too short (a problem with several), the collar neither too high nor too low, the material strong but not coarse. Te one fom Levi Strauss was, for Saphora, “very gay sailor”; she added that she liked gay sailors but that she did not think it suited Oscar or me. APC, the French company, sent a small, yet they were correct if they thought that their small was the equivalent of other companies’ mediums. We all three thought it had a certain dash, while the one fom another French maker, Lacoste, was far too baggy—although in my eyes ideal for tennis for that very reason. Te one fom Acne Studios was so nipply that Oscar looked as if he were auditioning for a porn movie. Te Armani samples looked more like underwear than something to wear in public. Te same was true of La Perla’s. (On the other hand, if a T-shirt’s [ c o n t i n u e d f r o m pa g e 1 0 4 ] 200 | T ow n A n D C o U n T R Y M AG. C o M intended function is indeed to be an undershirt, the ft is a diferent matter—unless, like Brando or Dean, you can aford to be seen in nothing but your undershirt.) One shirt I felt instantly allergic to as I tried it on—it was itchy and clingy—and then we all burst out laughing when we saw the way it ft me, which was, as they say, like a glove. Oscar could hardly get it on. It was, to my shock, by Jil Sander, a designer I have interviewed because of her art patronage. And there is no doubt that it was meant to be seen on its own. Te only other one that was equally out of the question was fom Burberry; the material was ribbed like corrugated cardboard. However, another T-shirt later in the testing—comfortable, neat in the way it conformed to the body without being too tight, the material exceedingly pleasant next to the skin—was also fom Burberry. I put on one whose collar was so close around the neck that I felt like a clergyman; when Oscar tried it on I expected him to be holding a chalice. It was fom Brunello Cucinelli, to me one of the most stylish and luxurious sources of men’s clothing; I decided they should stick to suede and cashmere. Two diferent but similarly “average—okay, but nothing to say” (Saphora’s take on both)— ended up being fom Prada. Ten Oscar tried on a shirt and simply said, “Tis takes the biscuit.” We agreed, both when it was on him and on me: marvelous to wear and somehow very good-looking. “Dior,” Oscar announced, when he found the very understated label inside it. We realized that what made it such a success was that it was considerably longer than all the others. Te hem’s being well below the waist—but not too far—was a pivotal diference. I then got out, fom my own chest of drawers, the shirt that had started the whole thing: my Vilebrequin. It was, we all agreed, impeccable, and Saphora felt that the white embossed turtle logo added a wonderful note. I also pulled out a shirt I had bought last summer and still had the tags on it. It was an exceptionally lightweight one made by James Perse, and I bought it to wear on an upcoming trip to rural Senegal, where the temperature rises above 110 degrees Fahrenheit. Tis confrmed Oscar’s and my opinion that Perse is absolutely terrifc. Tis small American maker had made, Oscar told us, the gray T-shirt he was wearing that day. Perse is to both of our tastes, for the subtlety of the material, the perfect style, the sort of elegance that goes with wooden houses and pine forests and sandy beaches. Yes, all in a white T-shirt. • Code Breaker Bloom syndrome, a rare condition that causes short stature and a greatly increased risk of cancer. At the moment she has 800,000 DNA samples in her database. To fnd more genetic connections with any certainty, she’ll need several million. Te value of these samples was proved at the beginning of this year, when the biotech giant Genentech agreed to pay up to $60 million to Wojcicki’s company for access to samples fom patients with Parkinson’s disease and their frst-degree relatives. While 23andMe was reined in by one government agency, another, the famously choosy National Institutes of Health, just gave it a $1.4 million grant to turbocharge the company’s web-based capture of data fom patients, so that some day it can marry what the company fnds in your DNA with what you tell it about your health. Even though she’s now colossally wealthy—something that seems hard to reconcile with the woman in the moisturewicking workout shirt laughing and juggling a dinged-up iPhone with a dead battery— Wojcicki ofen refers to work she did in her twenties, when she was a volunteer patient advocate at Bellevue Hospital in New York and later at San Francisco General. She asks me to speak for my profession and explain why patients still can’t see their own results fom clinical research studies they join. Te best answer I can provide is that it has always been this way. “People should be able to decide where their data goes,” she says. “If you want to share it for breast cancer research, then you should be able to decide to do that.” Tis is just one of the many popular conventions in healthcare she is determined to challenge. Wojcicki may be controversial, but she has earned the respect of even her competitors. Randy Scott is a co-founder of Invitae, a genetic testing company that works directly with doctors and genetic counselors, not customers. About Wojcicki he is clear: “She’s a sincere advocate for patients and is bringing the whole feld along by …
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