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sequencing platform provides comparable results to older sequencing methods. It specifically included mutations of the BRCA1 and BRCA2 genes, highly implicated in breast and ovarian cancer. Tests for those mutations were locked up for years by Myriad Genetics (NASDAQ: MYGN) of Salt Lake City, UT, which charged thousands of dollars per test. The Supreme Court’s 2013 dismissal of Myriad’s patents—making it impossible to patent a gene itself—allowed Invitae to exist. But it hasn’t slowed down Myriad much.
Myriad still owns about 90 percent of the market for hereditary cancer tests. It has pivoted by rolling its BRCA tests into a broader hereditary cancer panel and expanding its product line. It was profitable to the tune of $80 million, on $723 million in revenue, in its just-ended fiscal year, even though the sales bump it received in 2013 from Angelina Jolie’s famous disclosure, that she carried the high-risk mutation and elected to have a preventive double mastectomy, had already faded.
Its shares are actually trading about 25 percent higher than the week before the Court’s landmark decision. (When I contacted Myriad for comment, spokesman Ron Rogers referred to slides from a recent company presentation.)
Geneticist David Mittelman, a serial entrepreneur who has launched three genomics startups, says Myriad is still the gold standard. “The sequencing part of the test has been commoditized,” he says, referring to the identification of people’s DNA sequence, “but the interpretation of that sequence isn’t commoditized. While the gap will narrow in the future, Myriad likely maintains the most comprehensive database of variants at this time.”
Myriad has the revenues. 23andMe has the database. Helix has the hardware. Invitae has the cash. With its February IPO and a subsequent public fundraise, it has brought in more than $300 million. Scott predicts the company will ride higher revenues and cost-cutting—even while moving into larger San Francisco headquarters—to become profitable without going back to the markets. The firm posted a net loss of $43 million in the first half of 2015.
Staring any Big Data visionary in the face is also the reality of security and privacy: There’s very little of either. The U.S. has put in place some discrimination protection, the Genetic Information Nondiscrimination Act of 2008, which in theory means one can’t be fired from a job or denied insurance based on one’s genes. But what lies beyond? Anything can be hacked, as recent news headlines have demonstrated. And supposedly “de-identified” genomic data—stripped of personal tags, made anonymous—can be re-linked to its owner.
Even if our genomes aren’t stolen, can we trust the corporate keepers, or will they inappropriately spill the beans on our medical conditions? Remember the story about Target sending pregnancy-related coupons to a teenager’s house?
“These are new waters,” says Marcy Darnovsky of the Center for Genetics and Society in Berkeley, CA, who worries that in the era of consumer genomics, actual diagnosis that leads to better health outcomes will take a backseat to the shiny lure of genetics. “In certain situations, genetic testing is really useful,” says Darnovsky, citing in particular the rare single-gene diseases that can cause mysterious ailments in children and send parents on “diagnostic odysseys.” But in most cases, she says, reading our genes won’t be much help at all.
John Wilbanks of Sage Networks is a bit more optimistic. “Our knowledge is accreting slowly,” he writes. “But it does feel like the slope of the curve at which we accrete causal knowledge about genes is changing, which is a hopeful indicator. It’d sure help if everyone contributed what they knew to the global map of genetic information, because right now we’ve just got pieces of the map in place.”
Perhaps that contribution and accretion is inevitable, but by whom and under what terms is still very much up in the air. Invitae’s Scott acknowledges no system will be 100 percent secure. “That’s another reason you ought to be the one who owns [your own data],” he says. And you’re choosing to take on that risk.”
If people start to ask where they want their information stored and how much risk to take, Scott will be there to make his pitch: Do you want a company that says “‘Give us your data, we’re going to store it and then sell it and makes millions off it,’ then they have a data breach?” he asks. Or do you want “a company that says ‘You own and control your own data, we’ll do the best we can to secure it, but you’ll benefit from sharing it’? We’re not here to just exploit you to make money, we’re here to help connect you with people, and if and when appropriate you can monetize that. That strikes me as fairer system.”