Anne Wojcicki was feeling dispirited. It was the internet age: Google had rendered information universally accessible; Amazon could sell you anything, cheaply. But after seven years scrutinising healthcare companies as a Wall Street analyst, she couldn’t see any sign of healthcare joining the revolution. “I was frustrated,” she recalls.

But then she heard about a company decoding human genomes at an affordable price, and this sparked an audacious idea. “What if we made this affordable technology accessible to people?” she asked. If people could read their own DNA, they could know their own disease risks and change their lives or seek medical help accordingly.

She cites how YouTube, the video-streaming company now led by her sister, Susan, challenged traditional media by allowing anyone to broadcast video. “It was this idea of: give the power to the people . . . leverage this web 2.0 world,” says Wojcicki.

Iconoclastic ambition is in the stem cells of 23andMe, the company that Wojcicki, who graduated from Yale University with a degree in biology in 1996, co-founded with Linda Avey almost 12 years ago. Named after the 23 chromosome pairs that make up our genome, it sells kits for home DNA testing, a technology once confined to clinical settings. Customers spit in a tube and 23andMe has the DNA in their saliva analysed. It reports back certain genetic health risks, clues about ancestry, and idiosyncratic traits such as earwax type.

With venture capital investment of more than $491m, 23andMe has evolved from punky start-up to tech unicorn — a company valued at over $1bn — with a research arm and a drug discovery unit.

According to Wojcicki, more than 5m people have paid from $99 each to spit in 23andMe’s mail-order tubes. Permission from customers to keep and study their valuable DNA has contributed to a formidable bank of genetic information, which 23andMe charges pharmaceutical companies, including Pfizer and Roche, to access. It writes its own research papers and has ambitions to produce medicines.

But the Silicon Valley enterprise has come through a car wash of controversy.

In 2013, the US Food and Drug Administration (FDA), which regulates medical devices, banned 23andMe’s DNA analysis kit, saying it was being sold without its approval. Some medics worry that raw data produced by 23andMe’s tests are hard for people without genetics training to interpret. Others point out that some of the conditions the kit identifies a person’s genetic risk of getting, such as Alzheimer’s, do not have a medical solution.

Wojcicki is unrepentant. “If you go to the doctor today, to get what you want or go against what the doctor recommends, you have to be aggressive,” she says. “Healthcare is a $3tn industry. If you want to change a part of it, you don’t get it just by being nice.”

The company has about 420 employees and expects to hire “a couple of hundred” more this year. “I was recently asking about our maximum legal capacity in the building,” she says, laughing. “My board was concerned about that”.

In a sign of Wojcicki’s tech influences, that board includes Neal Mohan, YouTube’s chief product officer, and Roelof Botha, a partner at venture firm Sequoia Capital whose previous investments have included Instagram and YouTube.

Wojcicki, a California native, could not be much more Silicon Valley. Her sister Susan at YouTube is a former Google advertising executive, and Anne was married to Google co-founder Sergey Brin (they were divorced in 2015). Google was among 23andMe’s earliest investors. Driven in character — “it’s been a while” since her last holiday — Wojcicki is considering learning meditation.

More than 5m people have so far bought 23andMe’s saliva-testing kit, according to company co-founder, Anne Wojcicki
More than 5m people have so far bought 23andMe’s saliva-testing kit, according to company co-founder, Anne Wojcicki

Her take-no-prisoners attitude to genetic testing bears comparison to Facebook’s move-fast-and-break-things motto — the social media company’s Menlo Park headquarters are a 30-minute drive from 23andMe’s base in Mountain View. Such comparisons have exposed 23andMe to accusations of hubris.

After the FDA’s warning letter arrived in November 2013, “it was perceived that we have this arrogance”, says Wojcicki. But rather than trying to circumvent regulation, she argues that the company tried to inform the FDA and was instead guilty of “a failure of communication” and “a failure of trust”.

“The intention was always right,” Wojcicki says. “I want to be rebellious and aggressive, but in a way that is respected by the scientists and the community.”

As 23andMe pushed its health-related testing into other territories, including the UK, it mounted a charm offensive in Washington DC. According to Open Secrets, which tracks business influence on Capitol Hill, 23andMe has spent nearly $1.5m on lobbying services since 2011. Wojcicki hosted a lavish fundraiser for Barack Obama in May 2014 — tickets cost up to $32,400.

In 2015, 23andMe received limited FDA authorisation to tell customers if they carried genes for diseases that could be passed on to their children, and identify genes for certain rare diseases. Last year, 23andMe gained FDA approval to market its genetic tests for 10 diseases or conditions, including Parkinson’s, Alzheimer’s and coeliac disease. It was the first time the FDA had authorised a direct-to-consumer genetic test for genetic health risks.

To explore the test’s genetic warnings fully, however, 23andMe’s customers will need to consult the right doctor. Michael Watson, executive director at the American College of Medical Genetics and Genomics, cautions that there is little patients can do to address some diseases that the 23andMe test assesses for genetic health risk, such as late-onset Alzheimer’s. “I’m not sure what you’re going to do to alter your lifestyle,” he says. “There’s not a clinical intervention.”

Genetic testing in general has blind spots for people of non-white ethnic backgrounds, who are under-represented in databases against which DNA is compared.

Not everyone is convinced that the information 23andMe provides is reliable. Brianne Kirkpatrick, a genetic counsellor and ancestry specialist at the National Society of Genetic Counselors in the US, thinks that having more genetic information can help patients.

She stresses, however, the jury is out on whether 23andMe is delivering what people need. “Depending on who you talk to, whether 23andMe’s information is meeting that ideal of being both accurate and understandable, is up for debate.”

Wojcicki remains buoyant. Driving change, she says, means “changing the system”. She says she was inspired by the HIV-positive community’s fight to gain access to medication — won “not because they wore ribbons but because they stormed the FDA”.

“It’s not advocating violence,” she explains. “But you need to leverage the passion.”

A science commentator’s view

There cannot be many successful companies that want to make their customers spit, writes Anjana Ahuja. Enter 23andMe, which has found a way to spin saliva into gold.

The company has pioneered direct-to-consumer genetic testing (DTCGT), whose revelations can range from the entertaining (your quota of Neanderthal DNA) to the potentially life-changing (your genetic risk of developing Alzheimer’s or stroke).

The company has unsettled clinicians and commentators, including me, for overplaying the medical usefulness of its proposition. Even so, there is no denying that 23andMe deserves its award for boldness in business.

Its founders correctly predicted the genetic revolution in the laboratory would start a public clamour for personal genetic information. Its premise — to make personal genetics an issue of consumer empowerment, rather than a matter of purely clinical concern — has paid off. Today, 23andMe is the leading brand in a market estimated to be worth $340m by 2022.

More significantly, its vast DNA database has allowed it to move into the arena of personalised medicine. It takes vision and persistence to turn drool into a drug discovery pipeline.

Many consumers seek out these genetic tests to discover their heritage. The industry has even spawned a popular television format. Who Do You Think You Are? uses genetic testing to trace the family trees of celebrities. Without it, we would never have known that Danny Dyer, who plays a pub landlord in the gritty British soap opera EastEnders, is apparently a descendant of King Edward III.

While eliciting royal connections from humble DNA is a diverting pastime, pronouncing on future diseases is fraught with pitfalls. This is where 23andMe is in uncertain territory. On the one hand, it offers to reveal a customer’s genetic health risk of several serious illnesses by looking at various genetic variants (customers need to “unlock” this information — and not all choose to).

But, because so many variables, including diet and lifestyle, feed into overall risk, it is impossible to accurately predict which ailments a person will develop. Genetic testing companies say that knowledge allows people to make lifestyle choices: to eat less and exercise more, to give up smoking. Do we really need a test to tell us that?

The tests carry disclaimers that insist that the kits are not diagnostics. Many consumers will see impending catastrophe but not the multiple caveats — and will worry for their future.

In the case of Alzheimer’s, tests can prompt anxiety over a disease that has no effective treatment or cure. Tellingly, it is rare to find a clinical geneticist who champions the industry. For now, my own family’s medical history foretells as much as I usefully wish to know.

DTCGT is a golden key to unlocking our ancestral past but a somewhat unreliable crystal ball when it comes to divining the future. While I send the company my sincere congratulations, I will not yet be sending it my spit.

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