They employ doctors, prescribe tests, and for $2,000 a year they’ll help you keep on top of your health, but they don’t diagnose illnesses. That’s the line new Seattle health startup Arivale wants to walk in providing “wellness” help to its customers—who, Arivale officials stress, are “participants,” not patients.
“We aspire to help people optimize their current health,” says CEO Clayton Lewis.
Now Arivale has a big bankroll and backers to expand from Seattle into San Francisco and beyond. The company has secured a $36 million Series B round from Arch Venture Partners, Polaris Partners, and Maveron, a fund cofounded by Starbucks mogul Howard Schultz.
As Xconomy reported last month, the for-profit Arivale is being spun out of a not-for-profit long-range health study, the 100,000 Wellness Project, that originated at Seattle’s Institute for Systems Biology.
The 100K project grew from Institute president Lee Hood’s advocacy of so-called “P4 medicine”—predictive, preventive, personalized, and participatory—to paint as complete a picture as possible of all the study participants’ health through a range of medical technologies, including full genome sequencing, microbiome screening, and fitness tracking through wearable devices. (Hood is pictured above, in blue shirt, speaking with Arivale board member Bob Nelsen of Arch Venture Partners at an Xconomy event in May.)
The program aims to understand what constitutes wellness, or illness, or a transition between the two. Participants in the study are also paired with a coach to give health-related advice. (You can read a discussion here with Hood’s ISB colleague Nathan Price about the 100K project as it was just launching in mid-2014.)
Arivale will do similar work, with each customer paying $2,000 a year to receive a one-time full genomic sequence; blood, saliva, and stool-sample tests three times a year; and a FitBit to record daily data. All those tests are ordered by Arivale-affiliated physicians; the data are reviewed by the physicians, too, and if something odd in a customer’s profile crops up, Arivale urges that the customer share the findings with his or her doctor.
CEO Lewis, who is also a general partner at Maveron, cites the 107 people in Seattle who took part in the first phase of the 100K project. Forty-three of them were in a prediabetic phase entering the study, and Lewis says seven of them “normalized” those levels based on the feedback from the study.
One of those 107, University of Washington computer scientist Ed Lazowska, told Xconomy last month that when his bloodwork showed elevated levels of mercury, his coach quizzed him about his eating habits, revealing his love of tuna sushi. A switch to salmon brought his mercury levels down quickly. (Lazowska spoke to Xconomy before it was revealed today that he was on Arivale’s scientific advisory board.)
Despite a certain amount of intervention, Lewis says “we don’t diagnose and we don’t treat. The FDA doesn’t want companies in this space practicing medicine. But we’ll discover things that indicate” a certain likelihood of disease, he says.
Arch’s Nelsen, on the Arivale board via his firm’s investment, says the line between Arivale’s practice and medical practice “isn’t fuzzy at all.” The key, he says, is that physicians are ordering the tests for Arivale customers and reviewing the results.
Sometimes the company will decide that its coach can bring something to a customer’s attention, and sometimes it suggests the customer take the data back to a doctor, says Hood, a cofounder. “We don’t send a diagnosis,” says Hood. “We just say, ‘Look at these data.’ What they do is totally up to them.”
The Food and Drug Administration does not take kindly to entities providing health diagnoses or discussing risks without having the underlying test cleared or approved. Genomic test provider 23andMe found out the hard way in late 2013, when the FDA shut down the side of its business that would let customers send in a saliva sample and get back their genetic profiles linked to potential disease risks.
(23andMe has continued to sell ancestry-related reports and recently said it would use the reams of personal health data it has gathered to move into the drug discovery business. It also received FDA clearance in February to market a test for people to check if they are carriers of a mutation that would put their children at risk for Bloom syndrome.)
Arivale’s customers will have the option to share their data—with identifying information stripped out—beyond Arivale’s walls. The 100K Wellness Project continues and will use Arivale data, along with other data sources, says Hood. Hood thinks most people signing up should be willing to share, although Arivale needs to present the argument for sharing—the ability to pool anonymous data could drive research into the medicines of the future—“in the right context, and if we don’t, a certain fraction [of Arivale customers] will be resistant.”
23andMe is actually a great model, says Hood, getting its nearly 1 million users to submit other layers of information beyond their genomic profiles and giving them to option to share for research purposes.
Arivale is currently available only in Seattle. It plans to expand to San Francisco this fall. Its expansion requires offering blood tests locally, which means people outside of Seattle and San Francisco will have to wait until Arivale sets up shop in their towns, according to spokeswoman Gretchen Sorensen.
In addition to its funding round, Arivale is also unveiling today its scientific advisory board:
—Frances Arnold, California Institute of Technology
—George Church, Harvard Medical School
—Robert Green, Brigham and Women’s Hospital and Harvard Medical School
—Jim Heath, California Institute of Technology
—Lee Hood, Institute for Systems Biology (chair)
—Ed Lazowska, PhD, University of Washington
—Larry Smarr. University of California, San Diego
—Ralph Snyderman, Duke University
—Bonnie Spring, Northwestern University
—Eric Topol, Scripps Research Institute
Photo by Xconomy Seattle editor Ben Romano.