October 21st, 2015 Marco della Cava
SAN FRANCISCO—If you’ve always felt your brother-in-law was a bit of aNeanderthal, now you can prove it.
Among the 60-plus genetic tests available from a newly relaunched23andMe, a pioneer in the DNA-sequencing biotech space, is a breakdown of just how many simian traits we share. Here’s a tip: straight hair, sneezing after eating dark chocolate and, ironically, less back hair means more monkey genes.
But such whimsy aside, 23andMe’s relaunch Wednesday after a 2013Food and Drug Administration-mandated pause is centered on its expansive new Personal Genome Service, which includes a complete website redesign and new user experiences that include carrier status, wellness information, trait breakdowns and ancestry reports. The reboot also marks a significant step toward a future where crowdsourced genetic information can be leveraged to not only satisfy ancestral queries but also ultimately cure diseases.
This summer,Alphabet’s secretive end-of-aging project Calico made a deal to access DNA data from older users of Ancestry.com’s $99 test kits. And last year, diagnostics giantLabCorpbought DNA-analysis firm Bode Technology Group, opening up the possibility that it could eventually bring that company’s commercially focused tech to the masses.
“Our generation is used to getting information they need when they want it, and the idea that we can’t have access to our own health data is bewildering,” saysAnne Wojcicki, 42, who co-founded 23andMe in 2006 withLinda Avey. “If you can be proactive with your health, you can be more in control.”
That consumer-empowerment sentiment is echoed by the likes ofTheranosfounderElizabeth Holmes, 31, who started her highly valued, secretive pin-prick bloodwork company out of a personal mission to give consumers access to easy and inexpensive blood analysis without a doctor’s prescription.
For Wojcicki (pronounced woh-jiskey), 23andMe’s return reaffirms her belief that there is both a business case and moral imperative toDNA sequencing. The former is borne out by this past July’s $115 million Series E funding round led by Fidelity Management & Research, which brings 23andMe’s total to $226 million and a unicorn valuation of more than $1 billion. Other investors have includedGoogle Ventures, New Enterprise Associatesand billionaire Russian investorYuri Milner, who recently funneled $100 million toward a search for alien life.
One of the requirements made of 23andMe by the Food and Drug Administration was a revamped website that made genetic information easy to understand. (Photo: 23andMe)
And the latter is best exemplified by Wojcicki’s oft-stated desire to help find genetic clues to Parkinson’s, which runs in the family of Google co-founderSergey Brin. (Wojcicki is divorced from Brin, with whom she has two children; she is also the sister ofSusan Wojcicki, the CEO of Google-owned YouTube.)
Anne Wojcicki, who took breaks during her years on Wall Street to volunteer at New York City hospitals, feels that in time consumers will overcome their reluctance to sequence and share DNA.
“Health is the ultimate equalizer in society, and 23andMe is aimed at giving consumers a voice in a dialog that typically is between insurance companies, big pharma, physicians and hospitals,” she says. “The biggest barrier to adoption is education.”
For $199, 23andMe customers get access to a simplified website that translates a saliva sample into charted breakdowns of genetic traits and predispositions, tools to dive deeply into possible ancestral avenues and the option of having their genetic results be part of a broader pool of DNA research. If more detailed information is wanted based on one's genetic results, customers can access genetic counselors through the site.
Wojcicki and her Mountain View, Calif-based team have spent the last two years working with FDA regulators after the agency demanded that the company stop returning health results to customers until further evaluations of its science could be completed. In February, the FDA granted 23andMe the green light to tell users if they are carriers for Bloom Syndrome, which includes an increased risk for cancer.
Companies such as 23andMe and Theranos are being closely watched by the FDA as they press into new arenas where often proprietary technology crosses into the medical space.
"I think there's an internal battle at the FDA about where to go with such companies, but for the moment (regulators) are focusing on making sure tests are accurate and efficacious, which equals safety," says Mark Mansour, a partner at Washington, D.C., law firmMayer Brown, where he often represents biotech companies dealing with FDA inquiries.
The FDA's increased vigilance "has caused some of these new companies to scale down," says Mansour. "They want to work with the FDA of course, but you also have to protect your business model at some point. Ultimately, I think we have an explosion of (tech-driven) change happening that is exponential, and the FDA will have to adapt."
Ancestry.com is in talks with the FDA about "how to move into direct-to-consumer genomic health space," says Ken Chahine, executive vice president and general manager of AncestryDNA, a wholly owned subsidiary of Ancestry.com, which recently inked the deal with Calico to provide that project with genomic longevity data from its 1.2 million users.
"We're too early in the genomic testing game to be worried about stealing each others' customers," Chahine says of 23andMe. "This is undoubtedly a revolution that will sweep through many aspects of our lives in time. Most patient information is siloed in doctors' offices, and by aggregating this data we can truly improve health. For now though, it's about getting the word out."
One of the mandates FDA officials laid down for 23andMe was the need to simplify and clarify its user interface. "We had to prove to them that the average person could understand the information they were being presented with," says 23andMe vice president of product Brad Kittredge.
23andMe's current site features simple graphics that lay out information on what it means for the offspring of genetic carriers as well as where one's genetic information fits into the broader pool. "We added features such as 'share and compare,' which allows users to share their information with family and friends,'" says Kittredge. "Finding out this information certainly isn't for everyone, but we think there's a growing population that does want to know more about themselves. "
To date, a million people have signed up with 23andMe, with 80% agreeing to put their data in a pool for research purposes. The tests “are not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future,” according the company’s disclaimer.
That said, Wojcicki says the company will use its latest round of funding to work toward having a growing suite of FDA-approved trait tests that could one day “maybe lead to revolutionary cures.”
In the meantime, 23andMe could come in handy in settling some family feuds. For example, if someone in your clan seems to get wildly upset at the sound of loud chewing, they aren't odd or annoying so much as they're likely just the beleaguered carriers of a gene that occurs in 23% of women and 17% of men. The condition is called misophonia. You're welcome.