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DNA analysis kits hit snag

FDA claims it gave no approval to the startup

Washington Post
Anne Wojcicki, far right, chief executive and co-founder of the genetic profiling startup 23andMe, leads a discussion at a health care roundtable.

– In early May, Anne Wojcicki flew into Washington accompanied by two other well-connected Silicon Valley women intent on shaking up the health care industry.

Her genetic profiling startup, 23andMe, a darling of the tech industry, had recently run into trouble with the Food and Drug Administration. It was a setback for the company, but it had given her an important lesson in the power of government.

Wojcicki, 40, who is recently separated from but still legally married to Google co-founder Sergey Brin, was attending the White House Correspondents’ Dinner with her “team of girls,” as she called them. One was Lucy Page, wife of Google’s other co-founder, Larry Page. The other was Laura Arrillaga-Andreessen, wife of Netscape founder Marc Andreessen. It was Wojcicki’s first time at the soiree, a coming out for her on the political scene, and she had a lot to say.

The first is that the U.S. health care system is broken.

It was something she had been angry about since she was 27 years old, a Yale graduate armed with a degree in biology and working as a health care analyst on Wall Street. She remembers a stomach-churning event she attended where insurers and accountants talked about how to “maximize the billing opportunity” when sick people sought care. She couldn’t help but think of the patients dying of cancer at the hospital where she volunteered.

“I had this panic-attack moment,” she said. “I just suddenly realized that there are so many people trying to make money off the inefficiencies in the system that it’s never going to change from within.”

“It was bull----,” she said.

Now Wojcicki is a fabulously wealthy philanthropist, mother and chief executive of 23andMe, and if things work out as she hopes, many of us will live longer, healthier lives – and those medical billers she met years ago will be out of work.

The cornerstone of Wojcicki’s strategy is spit. 23andMe’s customers mail a test tube containing their saliva to the company, which analyzes their DNA. And for $99 they get back a report detailing any risk for more than 240 health conditions. In 2008, Time magazine named it invention of the year and celebrities gleefully tweeted their results.

But in November, the FDA ordered 23andMe to stop marketing its personal genome service because the company had failed to prove its technology. Regulators also expressed concern that the company might be misleading consumers with false negative or false positive results that could encourage people to self-medicate or make lifestyle changes for conditions they don’t have.

Wojcicki acknowledges that the company made mistakes. It didn’t fully understand the FDA’s deadlines or the documents it wanted. But she says the science itself is sound and she’s hopeful that, given time, the company will persuade the FDA to let it put the kit back on the market.

The youngest of three daughters born to a Stanford physicist and a high school journalism teacher, Wojcicki is a self-described super geek.

As a young analyst on Wall Street, Wojcicki had been frustrated by how a country with such wealth could fail to provide even the most basic medical needs to its citizens. By 2006, she had the connections to do something about it.

Wojcicki had moved to California to be with her then-boyfriend Brin and grew convinced that Silicon Valley, with its wonky algorithms and expertise in big data, could help.

For Wojcicki and her peers, disease wasn’t an inevitable part of the human experience. It was more like a math problem. “I think this is something the Valley can solve for,” Wojcicki said.

At a TED conference that year, she met an acquaintance of Brin’s named Linda Avey, a longtime biotech executive, and the two hit it off. Along with one of Avey’s friends, Paul Cusenza, a management expert, they pitched the idea of a DNA profiling company to Google, which invested $3.9 million. Others – Genentech, New Enterprise Associates and Mohr Davidow Ventures – soon followed.

They dubbed the company 23andMe, for the number of pairs of chromosomes in a human cell.

The company’s goals were two-fold. The first was to empower consumers with information about their own bodies. Wojcicki believed that the widespread availability of the spit test would change the relationship between health providers and patients for the better, giving consumers control over their own destinies

The second goal was even more wildly ambitious – to amass genetic information from as many people on the planet as possible. Wojcicki believed the cure for countless diseases and conditions was hidden in those strings of As, Cs, Ts and Gs. If we could figure out how to decipher the patterns, she said, we could cure countless diseases. As of June, it had amassed samples from 700,000 people – a data set that is believed to be the largest in the world and that has led to the discovery of numerous genes associated with illness.

In the hallways of 23andMe, Nov. 22 is a day that is referred to in infamy, like Pearl Harbor.

That’s when a scathing letter addressed to Wojcicki arrived by email from the FDA. It contained an ominous heading – “Warning Letter” – that was centered and in bold type. It ordered her to halt sales of the company’s personal DNA analysis kit because it had not been cleared by the federal agency. The regulator threatened “seizure, injunction and civil money penalties.”

Wojcicki recalled that she was shocked and confused.

Somewhere between a diagnostic and a medical device but neither one exactly, it had been unclear, at least in the early years, how 23andMe should be regulated. The kit had been on the market since 2007, but it wasn’t until 2010 that the FDA announced it would oversee the marketing of direct-to-consumer genetic tests. Since then, 23andMe had been working with the agency to gain formal approval for the product. The FDA had allowed the company to sell its product in the meantime, and, Wojcicki said, had given no indication of the depths of its concerns.

“Clearly we weren’t clear on what they were objecting to,” Wojcicki said.

Wojcicki said it’s early for her to have specific policy prescriptions for Washington. On health care, though, she’s clear: The need for change is urgent and great. It starts with the billing system, which she says creates perverse incentives for doctors, hospitals and insurers.

Wojcicki said one physician complained that the problem with 23andMe is that it “generates non-billable questions” in that many of the concerns the DNA reports raise can’t be solved simply by doctors ordering up drugs or operations.

As she sees it, doctors don’t need to be involved with all aspects of a patient’s care. They can fail to let consumers know all the choices they have or be unduly influenced by drug company marketing campaigns or overly paternalistic.

“The heart of the problem has to do with the fact that there is a third-party intermediary. You know the game of telephone you played when you were little?” she said. “The message never fully translates.”