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FORBES.COM JUNE 30, 20 19submitted DNA to GEDmatch, a free genealogy database.
“We have our days where, you know, Prime Day—we sell
a couple hundred thousand kits in a day,” says Wojcicki,
referring to Amazon’s discounted shopping day. (23andMe
sells its tests on its own website as well as through retailers
like Amazon, Best Buy and Walgreens. Soon Wojcicki plans
to open the first 23andMe pop-up retail store in a shopping
mall near its headquarters.) “I have my moments where I’m
like, an entire city is going to be impacted.”
Wojcicki admits she screwed up with the Feds. She com-
pares the fight with the FDA to walking around “a Japanese
house with our shoes on.” “It doesn’t matter if you believe
you’re right or wrong. You’re wrong,” she says. “So we had
to start over.”
One way out would’ve been to require a doctor’s approval
as part of the health test-ordering process, the approach
that 23andMe’s competitors, Silicon Valley startups Color
and Helix, have so far taken. But Wojcicki stood by her orig-
inal idea of a kit that could be sold directly to consumers.
The year 2015 marked the beginning of a rebound. That
February the FDA approved a carrier status report on a rare
disorder called Bloom syndrome (something Wojcicki car-
ries herself ). After proving to the FDA that its tests were
accurate and easy to understand, 23andMe became the only
genetics testing company with FDA clearance to sell genetic
health reports directly to consumers. Its Utah-based com-
petitor, Ancestry, which has sold nearly 15 million DNA kits,
doesn’t offer any health-related tests.
Also in 2015, 23andMe started signing deals with phar-
maceutical companies eager to dig into its genetics trove,
starting with multimillion-dollar deals with Genentech
and Pfizer. While they were happy to sell anonymized data
(from customers who opted in) to outsiders, Wojcicki was
also building out an in-house drug-research group and tap-
ping into a new revenue source: recruiting thousands of pa-
tients from 23andMe’s database for pharmaceutical firms’
clinical trials.
Wojcicki’s next big breakthrough came in 2017. Oprah
named its $99 ancestry kit one of her “favorite things.”
Then the FDA cleared 23andMe’s first health-risk report,
which could tell customers whether they have genetic vari-
ants linked with an increased risk for a blood clot condition
or Parkinson’s.
But the raft of approvals hasn’t squelched the medi-
cal community’s doubts. In fact, the fine print on its $199
health kits says they are “not intended to tell you anything
about your current state of health, or to be used to make
medical decisions.” Unlike a pregnancy test, the company’s
reports aren’t permitted to deliver any definitive diagnoses.
Instead, 23andMe’s carrier reports test for whether some-
one could pass variants for genetically inherited diseases
like hearing loss or cystic fibrosis to their offspring. Its 12
health-risk reports tell people whether they may be at an
increased risk for hereditary high cholesterol or late-onset
Alzheimer’s. They are limited in many ways. Since most ge-
netic research to date has been done on Europeans, the risk
reports rarely apply to African-Americans or Asians.
“No self-respecting doctor who has malpractice insur-ance is going to treat you based on your interpretation of a
direct-to-consumer test,” says Mark Rothstein, a bioethics
professor at the University of Louisville.
Perhaps the most controversial 23andMe test is one
that searches for three variants linked to breast, ovarian
and prostate cancer in what’s commonly called the Ange-
lina Jolie gene, BRCA1, and a related gene, BRCA2. Critics
say the problem is that there are more than 1,000 variants
linked to breast cancer, so searching for just three variants
fails to present the full risk profile. To top it off, the three
variants that 23andMe scans for are typically found in peo-
ple of Ashkenazi Jewish descent, just 2% of the U.S. popula-
tion. For most people it’s irrelevant.
“Effectively what you have is a technology that is nei-
ther that helpful [nor] that harmful, and so on the whole
should we really be encouraging people to spend $200 on
it, or should they spend $200 on a gym membership?” asks
Dr. Jonathan Berg, a clinical geneticist at the University of
North Carolina at Chapel Hill.itness fanatic Wojcicki would undoubt-
edly tell people to both test and go to the
gym, but to shore up the test side of the
equation she recently signed the company’s
largest-ever deal with GSK, giving it access
to 23andMe’s genetic database, which contains the DNA of
an estimated eight million people.
“The size of the data set can reveal lots of signals other
data sets that are much smaller would never be able to
show,” says Hal Barron, GSK’s chief scientific officer. The
early results are promising. In just ten months GSK and
23andMe have reviewed at least 13 genetic variants that
could be targets for diseases ranging from cardiovascular
to neurological. The first they will examine as a drug candi-
date is a mutation linked to Parkinson’s disease.
Drugs are a long-term play, taking 10 to 15 years to pay
off, if ever. In the more immediate future, Wojcicki is look-
ing for growth by shifting from giving tests to giving advice.
It’s an obvious move, but there are a host of competitors,
from smoking-cessation apps to diet- and exercise-tracking
tools by everyone from Under Armour to Apple.
The jury is out on whether any of these fitness and health
apps can make a difference, or whether 23andMe has any
meaningful advantage over the other players. No one needs
a genetic test to tell them that smoking causes lung cancer
or that scarfing down junk food leads to obesity. A genetic
test only provides personalized information. People still
have to change their behavior. And a raft of scientific studies
suggests that just giving them warnings won’t do the trick.
“It’s much easier to quantify the impact of drugs. It’s a
much harder problem to quantify the impact of preven-
tion. But I think that’s where mentally I’ll probably be more
proud,” Wojcicki says. “Because, right now, no one thinks
you can do it.”
“I’m really not a believer in the Silicon Valley world of,
like, you should live forever,” Wojcicki continues. “But I’m a
really big believer that you want to die in your 90s or 100s
—and you just want to be healthy.”ANNEWOJCICKI^—PRESCRIPTIONFORINNOVATIONF
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