23andMe wants to reveal health risks using your DNA

  • 02 Dec 2014
Jason Madara


Anne Wojcicki
Anne Wojcicki
Jason Madara

Anne Wojcicki's grandmother, Ruby, rushed her 15-month-old son David to hospital near their home in Sunland, Los Angeles, in March 1950. She had found the infant playing with an open bottle of aspirin. "They told him to go home and take a nap. So they went somewhere else where they pumped his stomach and sent him home,"

Wojcicki says today. "She then went to another hospital and they sent my mother and my grandmother home, but kept him in. The next morning when my grandmother called, they said to her, 'Your son is in the morgue. You can pick him up.' "My mum doesn't trust the system and she hammered it into me that you can't just trust that somebody is going to do the right thing for you. If you want to have the best health outcome, you need to be in charge of your health."

Wojcicki's personalised-genetics company 23andMe aims to do just that. By offering customers individual genomic information -- spit in a test tube, post it to a laboratory and, a couple of weeks later, you'll receive a report detailing health conditions towards which you may have a genetic predisposition -- it aims to give people the data that is currently languishing in silos. Wojcicki wants individuals to take control of this information to adapt their behaviour, arguing that this targeted data should be fully integrated into the health system to drive efficiencies and superior patient outcomes. Wojcicki's ideas seemed distant a decade ago when the human genome had just been mapped at a cost of £1.85 billion, and scientists and entre-preneurs were still establishing practical uses -- and business models -- for the determination of chemical base pairs.


Still, the world she envisions would be approaching faster if she were not facing huge government roadblocks. These have limited 23andMe's product offering in the US to a DNA ancestry service that offers information on what percentage of a customer's genome relates to particular populations across the world, making it easier to find relatives and trace paternal and maternal lineages.

The US Food and Drug Administration (FDA) has blocked the company's wider health offerings -- risk factors for diseases, for instance -- pending regulatory approval. Wojcicki wants health records to be as easy to access as online banking and her story, and that of her company, epitomises both the promises and the challenges of the ongoing worldwide genetics revolution. "It's your job to manage your health," she says. Despite its problems in the US, the full 23andMe service launched in Canada in October and was due to launch in the UK at the time of WIRED going to press.

23andMe markets itself as a consumer-friendly personalised-genetics concern. But its product offering is wrapped around a core of hard, rigorous science. It starts with thousands upon thousands of vials of human saliva.

Customers receive an empty vial, fill it with spit and return it to a lab where the customer's DNA is extracted from the saliva.

This DNA is then copied multiple times in a process called amplification, until it grows to the point where it can be genotyped (meaning the point at which differences can be determined when compared to other samples). In order to do this, the amplified DNA is cut into smaller pieces, which are then applied to a customised DNA chip, known as a microarray: a small glass slide with millions of microscopic beads on its surface. Each bead is attached to a "probe", a piece of DNA that matches one of the genetic variants that 23andMe tests.

23andMe doesn't sequence an entire genome -- the human genome contains anywhere between ten million and 30 million genetic variants, many of them closely correlated, meaning certain variants are highly repre-sentative of thousands of others. So the company's scientists have selected tens of thousands of variants linked to various conditions and traits identified in genetic liter- ature.

Cut pieces of DNA stick to the matching DNA probes.

A 23andMe vial requires 2ml of saliva. Add a stabilisation buffer to ensure the sample keeps fresh
Jason Madara


A fluorescent signal on each probe tells which version of a certain genetic variant corresponds to the DNA being tested. These are compiled into a report which lets customers know their genetic predilection towards, say, Type 1 diabetes, breast cancer or Parkinson's disease. Wojcicki's own family has made lifestyle changes after receiving the results of 23andMe's genome mapping: her estranged husband, Sergey Brin, the cofounder of Google, was found to have a high risk factor for Parkinson's. "His mother has Parkinson's disease, he had another family member who has the disease, so he has a 50/50 chance of developing it," Wojcicki explains. "We're more proactive. We try to be aware. He exercises more, he drinks more coffee because that is associated with reducing the risk. Personally, I'm high risk for breast cancer, so I mitigated my alcohol consumption."

It is September 2014 and Wojcicki is welcoming WIRED to the 23andMe office in the middle of the Google site in Mountain View, California. Wojcicki is the public face and voice of 23andMe, inseparable now from the product andits mission. By the time she emerged into public view, she'd already made a fortune as part of a Wall Street hedge fund. "Wall Street emphasises the point that my mother taught about the conflict of interest between health and money," she says. "From a Wall Street perspective, it's all about how to monetise issues like the obesity crisis or diabetes. It leads to the question about who makes money from me not getting sick? If you actually stay healthy, the system doesn't make money. Is that a conflict of interest?" Sergey Brin started his company in 1998 in a garage owned by Wojcicki's sister Susan, who would later become the CEO of YouTube. Anne Wojcicki was brilliant and rich, in possession of a science degree from Yale and unafraid of, and deeply knowl-edgeable about, big business. She had grown up in the right place at the right time. It also helped that she was nerdy enough to sustain an all-consuming passion for genetic science. As the sequencing of the first human genome neared its completion in the mid-2000s, Wojcicki felt tremendous excitement about the potential health benefits. She could sense the potential of combining genomic science with big data. She envisioned a world where diseases could be targeted via millions of discrete genetic data points, and where everyone would have access to as much genetic health information as they needed. Countless lives would be saved and transformed. "23andMe starts this revolution," says Wojcicki. "If I really want to be healthy, we need to have a parallel consumer universe. You need to have ownership of your own information, you need to be proactive, you need to be the one taking charge." 23andMe launched with early funding from Brin, Google and Genentech. On November 17, 2007, the company announced the launch of its Personal Genome Service, at a cost to the public of $999 (£636). By 2008, the company was being featured on Oprah and had been awarded Time magazine's "Invention of the Year". The New York Times ran an article describing how 23andMe's saliva tubes were all the rage at the 2008 Davos conference.

Through his 23andMe profile, Brin learned that he was a carrier of LRRK2, a genetic mutation in the 12th chromosome that greatly increases his risk of developing Parkinson's. His mother, also a carrier, had contracted the disease. This gave 23andMe a little extra narrative push. Could the billionaire, via diet and exercise, turn back this horrible disease? Could his genome provide vital clues to a cure?

When, in 2010, 23andMe's major competitor Pathway Genomics announced plans with the pharmacy chain Walgreens to put saliva kits in stores around the US, the federal government raised a red flag. Within 48 hours, the FDA had sent letters to every direct-to-market genetics company, having decided that the products were medical devices that required clearance. Other government agencies also put out warnings, saying that there were no clear standards for genetics testing. 23andMe wrote an open letter to various government agencies saying that it was willing to work to help establish those standards.

The competition got scared off. Within two years, 23andMe's was the only over-the-counter genetic test available. It published papers about Parkinson's, announced research communities for sarcoma and other blood cancers and received a million-dollar grant from the US National Institutes of Health. By 2013, it was offering tests, providing data on more than 200 health markers, for $299 (£190). Further funding, taking the total from investors to $110m (£70m), was then used to drop the price to $99 (£63). The customer base shot up to 700,000 people on the back of the company launching a slick TV advertising campaign. Fast Company magazine featured Wojcicki on the cover, declaring her "The Most Daring CEO in America".

Then, on November 22, 2013, the hammer fell. The FDA sent Wojcicki an ominously titled "Warning Letter", telling her that, in essence, it was cutting 23andMe's operation off at the knees, threatening "seizure, injunction and civil money penalties". The letter took shots at the TV advertising campaign and seemed concerned that 23andMe was releasing allegedly inaccurate results.

It also implied that, even if the results were accurate, people who received them wouldn't know what to do with them. "Everyone has the right to access and understand their personal genetic information," says Wojcicki. "It's amazing to me it's so controversial that you should be able to get your genetic information."

On December 1, 2013, the company's website offered "reports on 240+ health conditions and traits". By December 5, it was promising merely "ancestry information" and "raw genetic data without interpretation". And that's where it stands for US customers today.

23andMe samples are prepared by LabCorp technicians in Los Angeles for DNA extraction
Jason Madara

Soon, the lease on 23andMe's office on the Google campus will expire, meaning that the company will be relocating to what Wojcicki describes as an "extremely cool" new space downtown.

The current space is an unremarkable warren of office cubicles and conference rooms but, in the middle of the site, there's a full gymnasium where, one afternoon, WIRED takes a yoga class as busy workers' keyboards clack all around. Every day, 23andMe employees receive a healthy, catered lunch, along with a full menu that includes a detailed description of the cheese of the day. When WIRED visits, it is "a Gouda-like cheese with a yellowish tan wax rind and pale-yellow flesh, made for three months during the spring, while the cows are feasting on meadow grass".Some of that rarefied cheese is on display at a lunch meeting with Wojcicki. The CEO is wearing workout shorts, a jogging top and grey Chuck Taylor trainers; she has ridden several kilometres from home on an ElliptiGO, a £2,000 stand-up bike with training pads instead of pedals. 23andMe makes ElliptiGOs available to employees at all times.

This is the only hour Wojcicki has free in her schedule for the following month, such is the cofounder's diary now that she's spending much of her time dealing with a federal agency. In the past, 23andMe has operated without a general counsel; Wojcicki has been distracted by having two young children, and hasn't been going to Washington as often as she could have. "We were out on a three-day off-site, talking about the next five-year plan," she says, recalling the regulatory intervention. "It never crossed my mind that the FDA would ask us to stop."

But ask it did. After the FDA's intervention Wojcicki didn't leave her home office for seven days, calling everyone she could. "One of the best pieces of advice I got from a senior regulatory person in the Valley," she says. "We sat down, and she said, 'Are you trying to have a cash-out strategy? Because that's one path. But if you really want to change the system, and you want to dominate in ten years, that's a different strategy, and that's going to take patience. You have to hire the right people, you have to build a team.'"

Wojcicki hired the best genetics lawyer she could find and engaged with the FDA."We weren't speaking the right language for them," she says. "They didn't understand our process. I get it now."

For the past year Wojcicki has travelled to Washington every few weeks, meeting with Congress members, sitting on a prestigious genetics committee, and, most importantly, trying to satisfy the FDA's concerns. She's also been playing her high-powered tech celebrity card, attending a White House dinner wearing a Victoria Beckham gown, and, on a separate occasion, hosting President Obama at a $32,000(£20366)-a-plate exclusive dinner at her private estate.

The cultural gap between Washington and Silicon Valley can and will be bridged, she says. She's less sanguine, however, about the overall state of the US healthcare system. To her mind, recent reforms haven't changed much. Genetics still isn't taught in most medical schools. Therefore, physicians don't know the field, and the insurance apparatus that rules US healthcare knows and cares even less. The roadblocks are numerous and intense."Everyone talks about the vision as though it's obvious," she says. "They're like,

'Oh yeah, we'll just cure cancer. In ten years, every child born today will be sequenced.' People talk about it like it's inevitable. But there's nothing I see that's happening today that's going to make that a reality. And, to be honest, I find that really depressing."

The full story will be out in WIRED's 2015 February issue. Be the first to read WIRED's articles in print before they're posted online, and get your hands on loads of additional content by subscribing online.