Regulators just gave DNA testing startup 23andMe the go-ahead to offer a health product that scientists have called dubious


23andMe Co-Founder and CEO Anne Wojcicki speaks onstage during TechCrunch Disrupt SF 2017 at Pier 48 on September 19, 2017 in San Francisco, California.

23andMe Co-Founder and CEO
Anne Wojcicki

Steve Jennings/Getty
Images for TechCrunch


  • Anne Wojcicki, the CEO and founder of Silicon Valley’s
    most popular genetics testing startup, 23andMe, said earlier
    this month that she hoped the company would

    add a new
    health offering
    that looks at how you process medications,
    including those for depression.
  • 23andMe, which made headlines recently on the heels of
    a new
    $300-million partnership with drug giant GlaxoSmithKline
    ,
    currently offers health screenings for some of the genes
    involved in breast cancer, Alzheimer’s, and
    Parkinson’s.
  • On Wednesday, federal regulators gave 23andMe the green
    light to add the test to its lineup.
  • Albertsons pharmacies and gene testing startup Color
    Genomics offer the same type of test for $250-$750, but many

    scientists say it’s not worth the money
    .

Anne Wojcicki, the CEO and founder of popular Silicon Valley gene
testing company 23andMe, said earlier this month that she didn’t
feel like the company was currently offering what she called a
“complete product.”

That’s because the current gene testing kit — which includes
health screenings for some of the genes involved in Alzheimer’s,
Parkinson’s, and breast cancer — did not include a
test that looks at
how you process medications, including
those for depression.

But on Wednesday, Wojcicki’s company got the green light from the
Food and Drug Administration to offer the test.

The
tests
, which assess genes involved in the break down of
antidepressants in the body, are
currently being offered
by psychiatrists and Albertsons
pharmacists in three major cities at a hefty price tag of $750.
Just last month, another Silicon Valley genetics testing startup
called
Color Genomics
began offering the test as part of its $250
kits. 

Many scientists feel the tests don’t offer a clear benefit to
people and say that in many cases they are not
worth the money
. Among other issues, the tests may give

conflicting results to the same patient
for the same
medication and don’t tell providers which specific medication is
best, according to experts.

‘When we can bring pharmacogenomics back, then we have a complete
product back’


23andMe kit
Lydia Ramsey/Business Insider

In the early days of 23andMe, the company included a test for
depression medications in its lineup of health offerings,
Wojcicki said. But in 2013, the FDA forced the company to stop
selling those products and get federal approval on the grounds
that the tests could be misinterpreted as health advice. The
company was allowed to continue selling the genealogy component
of its kit, which looks at ancestry.

Last year, the FDA gave the company the green light to again sell
some of its health screenings. On the heels of that decision,
23andMe rolled out a limited selection of some of its original
products. The most recent addition, unveiled in March, is a

test
for some of the genes involved in the risk of developing
breast cancer, also known as
BRCA
genes.

Now, the company was only missing one of those original health
products, Wojcicki said: a test for depression medications, also
called pharmacogenomics.

“The only one we don’t have back yet is pharmacogenomics. We used
to have that and we’d like to have that one come back,” Wojcicki
said earlier this month at a panel discussion at the Rock Health
Summit in San Francisco.

“When we can bring pharmacogenomics back, then we have a complete
product back,” she said.

What the FDA approved

It remains to be seen how the company will roll out the new
pharmacogenomics test to customers. Because 23andMe sells its
tests directly to people (they can be purchased online and at a
selection of drug stores), it needed to get FDA approval first.

That happened on Wednesday.

“This test is a step forward in making information about genetic
variants available directly to consumers and better inform their
discussions with their health care providers,” Tim Stenzel, a
director in the FDA’s Center for Devices and Radiological Health
said in a statement. 

The test could be incorporated into the existing health lineup,
which currently includes tests for Alzheimer’s, Parkinson’s, and
breast cancer for $199, or it could be sold as a stand-alone
test.

Color Genomics chose to incorporate its new pharmacogenomics
product into its existing $250 test. Unlike 23andMe, which sells
its services directly to consumers, Color requires people to
order their tests through a medical provider. In addition, the
company mandates talking with a professional genetics counselor
and a clinical pharmacist to avoid potentially dangerous
misinterpretations of the results.

Genomind and Assurex, the two companies who offer a standalone
pharmacogenomics product, sell the test through psychiatrists and
some pharmacists for $750.

Wojcicki did not provide further details on how much the test —
should the company ultimately choose to offer it — would cost or
when it would be available. A company representative also
declined to offer Business Insider more information about the
test. But Wojcicki said she saw the pharmacogenomics service as
part of the company’s overall mission to help empower customers
with more data about themselves and prevent negative health
outcomes when possible.

“I think one thing genetics can do is help prevent a lot of early
deaths,” Wojcicki said.

Still, the FDA’s Tim Stenzel offered caution for people who get
the test:

“This test should be used appropriately because it does not
determine whether a medication is appropriate for a patient, does
not provide medical advice, and does not diagnose any health
conditions.”