23andMe and Anne Wojcicki: Using DNA Data to Transform Health Care

23andMe

In addition to being Women’s History Month, March brings us the gift of March Madness. To celebrate these themes in tandem, Distillery is running a four-blog series that features fitness tech innovation and two tales of successful health-focused businesses founded by women, ClassPass and 23andMe. Welcome to the third blog in the series: the story of 23andMe and its fearless CEO and co-founder, Anne Wojcicki.
 

23andMe CEO and co-founder Anne Wojcicki is Silicon Valley royalty – her ex-husband, with whom she’s still close, is Google co-founder Sergey Brin – with an estimated net worth of $1B. She’s dated A-Rod. She counts Ivanka Trump among her friends. But she’s not what you think. Not in the least.

Wojcicki played ice hockey during college. She does not like “frou-frou things,” and she makes liberal use of the word “dude.” She married Brin while wearing a white swimsuit and no makeup. (She readily admits using the couple’s swimming-themed wedding in the Bahamas as an excuse to avoid any hair-and-makeup nonsense.) She’s famously frugal, shopping for shoes at Payless and cutting her children’s hair herself. She explains, “My mother always said it’s cheaper to wear a jacket than it is to heat a house.” In her work uniform – generally Lululemon shorts and a t-shirt – she does her daily rain-or-shine bicycle commute to the 23andMe office in Mountain View, CA, a seven-mile round trip. When she met A-Rod, she genuinely didn’t know who he was, texting a friend, “I think he plays for the Yankees.”

In other words, Anne Wojcicki is really not what you think.

Finding Her Mission: Disease-fighting Consumer Empowerment

It probably suits Wojcicki (pronounced Woe-JIT-ski) that her name is difficult for people to pronounce. While Wojcicki is clearly a force, she doesn’t want your attention on her. Instead, she wants you to understand the vision of her company and central passion, 23andMe. After all, she’s only trying to revolutionize the way health care works.

Direct-to-consumer genetic testing and biotechnology startup 23andMe, established in 2006 by Wojcicki and co-founders Linda Avey and Paul Cusenza, was founded with two goals in mind: to empower consumers by giving them greater access to their own health information, and to amass an unprecedented stockpile of genetic information about as much of the world’s population as possible.

In part, Wojcicki was motivated by her 10-year stint post-graduation working for biotech-focused investment firms on Wall Street. She was horrified by the companies making money off sick people whose CEOs insisted it wasn’t their responsibility to understand how their companies’ drugs worked. Nobody seemed focused on genuinely solving health problems, or on empowering consumers to take control of their own health. As Wojcicki told the Wall Street Journal, “The existing health-care system is focused on treatment, not on prevention, because prevention doesn’t make money.”

In a MAKERS profile video, Wojcicki recounts another inspiration that led to the company’s founding. She was having dinner with a scientist who was working on a genetics project, and she asked him, “If you had the world’s data – if every single person in the world was sequenced, and you had their medical records – would you be able to solve most health care problems?” When he answered with an unequivocal yes, she was convinced. She would create a way to gather that data and use it to benefit the people who supplied it.

“Big data is going to make us all healthier,” asserts Wojcicki in an interview with Fast Company. “Genetics is part of an entire path for how you’re going to live a healthier life… Everyone’s going to die and everyone’s going to get sick at some point. But I do believe that there are choices you can make in life that will make you as healthy as possible.”

A Healthy Pedigree

A biology major at Yale University and (at one point) a would-be doctor, Wojcicki has always been infatuated with the science of the human body. She remembers the exact moment when, at the age of six, her mom first explained to her the concept of “genes.” She’s been fascinated ever since.

It’s worth noting that braininess and drive are quite literally in Wojcicki’s genes. Her father is a renowned physics professor at Stanford University, her mother is a renowned teacher of journalism, her sister Susan is a former Google executive and the current CEO of YouTube, and her sister Janet is a Fulbright-winning researcher, anthropologist, and epidemiologist at the University of California. In the Wojcicki family, it seems nearly inevitable that your life’s work will have an impact.

Spitting: Good for Your Health

Drawing on $8.95M in initial funding from Google, Genentech, and other investors, Wojcicki turned her vision to action. 23andMe first offered its testing services to consumers in late 2007, using DNA from consumers’ spit samples to develop reports covering a range of health and genetic information. The initial price tag for the service was a hefty $999. To drum up interest, Wojcicki held “spit parties” with celebrities, politicians, and C-suite luminaries. (She once held a spit party at the World Economic Forum.)

By mid-2008, 23andMe was able to reduce the price to $399. In late 2008, Time named 23andMe the “invention of the year.” But consumers were still slow to get on board. For most consumers, the value of genetic testing data was still a mystery.

The work quickly became even more personal for Wojcicki, when her then-husband Brin’s 23andMe test results showed that he carried a genetic variant sharply increasing his likelihood of contracting Parkinson’s disease. The results also meant a 50% chance their two children could inherit the risk. Brin rapidly made lifestyle changes thought to reduce the risk of Parkinson’s (e.g., drinking coffee, exercising), and 23andMe became highly involved in Parkinson’s research.

Uncharted Territory Brings a Thorny Path

As the first direct-to-consumer genetics service, 23andMe is navigating entirely uncharted territory. So it’s not surprising the company has sometimes made errors and missteps as it forges its path. Unfortunately, the biggest, most unfortunate misstep was failing to understand the need to proactively work with the US Food and Drug Administration (FDA) to provide both the FDA – and to some degree, the global scientific community – with sufficient proof about the accuracy of their genetic data, or sufficient clarity about how they were presenting that data to their customers.

The FDA was in communication with 23andMe starting in 2008. Then, as Nature reports,

“In 2009, the FDA started asking 23andme for evidence that the company’s products worked as advertised and wouldn’t harm customers. The agency was worried that people might take drastic medical measures on the basis of their test results, such as deciding to change the dosage of their medications without consulting a doctor or undergoing unnecessary surgery, such as a mastectomy, or treatment based on false positives. Regulators demanded evidence that the tests were accurate, and that customers were well informed what the results meant.”

In other words, the overarching concern was that, without medical consultation, consumers couldn’t be trusted to understand and know what to do with the data they were receiving. The scientific community also worried that people wouldn’t understand the big picture surrounding these risk analyses. For example, as one genetic counselor explained to Fast Company, a variant showing a 10% increased risk over the general population of getting Disease X “is a completely useless thing to find out, because the amount that variants contribute relative to lifestyle, diet, exercise, and weight is tiny.”

In 2010, the FDA formally notified 23andMe and several other genetic testing companies that their products require FDA approval. The FDA continued to communicate with 23andMe over the next several years, repeating the same questions, and as late as 2013 23andMe was still promising that data would be forthcoming. But – after 23andMe stopped communicating with them in May 2013 and proceeded to launch a high-profile advertising blitz – the FDA lost patience. In November 2013, the FDA ordered 23andMe to stop marketing its product. While the company was permitted to continue issuing reports that were solely ancestry-based, it was no longer authorized to dispense any health-related information to consumers.

It was a massive blow to both 23andMe and Wojcicki. A more typical entrepreneur might have cut and run. But, again, Wojcicki is not typical.

Making the Data – and 23andMe’s Intentions – Clear

Undeterred, Wojcicki hired regulatory experts and began the slow climb back into the FDA’s good graces. As she explained to The New York Times, 23andMe wasn’t trying to circumvent the regulators. They simply hadn’t yet understood the culture they were operating in, and they weren’t communicating their intentions in the right way. “It took us a long time to generate a lot of data to prove that our intentions actually were right. But I feel like we’re doing the right thing in terms of proving that the customer is capable of getting this information on their own.”

23andMe works hard to make certain the reports they issue are easy for consumers to understand, so that customers know what their data means. The company’s literature and talk track keep it simple and consistent: Risk factors don’t mean you WILL get Disease A or B, but simply that you’re at risk, and that understanding these risk factors can help you make better choices to reduce your risk. The reports – covering a range of information about ancestry, carrier status, wellness, and physical traits – offer up tailored guidance on lifestyle and diet changes that may reduce risk in each area identified.

FDA approval or not, 23andMe celebrated countless milestones in the years leading up to and during the FDA block. They partnered with the National Institute of Health (NIH) on initiatives to improve genetic testing techniques, develop research tools, understand the genetics behind allergies, and increase health research in the African-American population. Working in partnership with the Michael J. Fox Foundation, they’ve made huge advances in Parkinson’s research. They’ve made several genetic discoveries on physical, athletic, allergy, and habit-related traits (e.g., identifying genetic traits related to “morning people”). They initiated collaborations with Pfizer and Genentech.

In 2013, Wojcicki made key hires to boost consumer outreach; those hires used focus groups to assess 23andMe’s consumer base. Ultimately, to surmount concerns about privacy and uncertainty about an entirely unprecedented service, they decided to focus on consumers seeking to be proactive about their health.

In tandem, public awareness about the power of genetic testing begin to grow. Following Angelina Jolie’s highly publicized 2013 decision to undergo a preventive double mastectomy after she found she carried the BRCA1 gene variant that sharply increases the risk of developing breast or ovarian cancer, 23andMe experienced a rush of consumer interest. As genetic testing startups and enterprises such as 1997’s Ancestry, 2003’s MyHeritage, 2015’s Vitagene, and 2016’s LivingDNA (an offshoot of 2004’s DNA Worldwide Group) have grown in visibility and consumer acceptance, so too has consumer willingness to send in their spit samples for analysis. It doesn’t hurt that most of these companies – including 23andMe – now offer $99 genetic testing packages, a price point far more accessible to the wider population.

Back in Business

In February 2015, 23andMe received their first FDA approval on a single test for a rare disorder, Bloom syndrome. This move made 23andMe the first company to be FDA-approved to market *any* direct-to-consumer genetic test. (Specifically, the test could tell parents whether their future children were at risk of inheriting their genetic risk for the disease.) While the disease’s rarity meant it was only a small step toward providing consumers with the kind of far-reaching data 23andMe wants to dispense, it was a step in the right direction.

The year 2015 also saw the formation of 23andMe’s Therapeutics Division, a research and drug development group dedicated to the discovery and development of new treatment therapies. The group, which uses 23andMe’s database to identify and research targets to support future clinical development, marks another major step toward Wojcicki’s vision of using 23andMe’s data stockpile to improve global health.

The next big breakthrough with the FDA didn’t come until early 2017, when the FDA cleared 23andMe to market genetic tests that inform consumers of their potential risk for 10 specific conditions, including far-reaching conditions such as Parkinson’s disease, late-onset Alzheimer’s disease, and celiac disease. The FDA also granted 23andMe an exemption that will make it easier to get additional tests approved in the future. Though 23andMe’s pre-2013 reports provided risk analyses for 254 diseases – you know, a little more than 10 – it’s still a massive step forward for the company.

Notably, the FDA’s exemption for 23andMe still excludes tests for known cancer-related variants such as BRCA. That’s because the FDA remains largely unconvinced that consumers can be trusted to process that kind of potentially life-changing genetic data without the guidance of medical practitioners. But Wojcicki hasn’t given up. In an interview with Glassdoor, Wojcicki explains it thus: “I feel a responsibility to our customers to get important information out to them. I have seen over the last few years just how much this information can impact lives for the better. I am driven by the desire to have better and better health information for individuals so we can all make better decisions in our lives.”

Indeed, 23andMe takes its responsibility to its customers very seriously. As the company’s website explains, everyone at 23andMe always remains fully aware that “there are real people on the other end of every decision, every interaction, and every data point.” After all, without the trust of their customers, 23andMe would be powerless to fulfill its mission.

Consumers and Businesses: Crucial Partners in 23andMe’s Mission

The trust 23andMe’s customers place in the company and its mission has had a result surprising to many in the industry: The incredible majority of their customers opt in to participate in research. In other words, the everyday people who make up 23andMe’s customer base are willing to turn over their data in the hopes that it can help the scientific community find the means and the medicines to combat diseases and disorders. According to 23andMe’s website, of their more than 5 million customers, more than 80% have opted-in, with each individual contributing to an average of 200 different research studies. 23andMe and its customers are true partners in wanting to drive progress in genetic and biomedical research.

To be clear, 23andMe keeps its customers’ data fully confidential, providing the data to scientists in the form of anonymized reports. But the simple fact is that 23andMe now sits atop the world’s largest database of human health information. “They have quietly become the largest genetic study the world has ever known,” says Stanford University cardiologist Euan Ashley.

The company has now received investments from or established more than 20 partnerships with many of the world’s most powerful biotech and health enterprises, including the NIH, Pfizer, Roche/Genentech, and Proctor & Gamble. These organizations are using 23andMe’s data to fuel groundbreaking work on Parkinson’s disease, depression, rosacea, and other areas.

Fueled by Momentum, Dedication, and Passion

In 2017, Nature estimated that the direct-to-consumer genetic testing industry will grow to more than $340M over the next five years, and that over the same time period, the overall DNA testing market will reach $10B. 23andMe is already seeing that uptick: Investors peg 23andMe’s current worth at more than $1B, meaning it’s now considered a rare but wondrous “unicorn” startup in the investment community.

Wojcicki, for her part, won’t give up anytime soon. It’s clear that she’s genuinely invested, or she likely would’ve given up when the FDA essentially shut down her dream for several years. In a lighthearted interview with Karlie Kloss, Wojcicki explains that her parents gave her strong guidance that she lives by, encouraging her to take risks and pursue the things that she’s passionate about. They also taught her to be frugal, giving her the ability to know how to save and not spend. Since she doesn’t crave a lot of material goods, she explains, “It made me free to then choose a career that I wanted, and it also made it that I was never afraid to quit.” Wojcicki has made it clear she’s not afraid of failure. What’s also become clear is that if she’s investing her time in any endeavor, you know she’s passionate about it. If she’s not? Dude, she’ll quit. She’ll go do something else. And whatever she does, she’ll still conduct business meetings in her Lululemon shorts and t-shirts.

In other words, as long as Wojcicki continues at 23andMe, you can be certain she’s still a believer – in the strength and importance of the startup’s mission, and in the potential that what they’ve built can make a genuine difference in improving people’s health worldwide.

Want to learn more about how Distillery uses technology and analytics to support the world-changing, industry-disrupting ideas of startups and enterprises? Dude, let us know!
 

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