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Phlebotomy.
Even the word sounds archaic—and that’s nothing compared to the slow,
expensive, and inefficient reality of drawing blood and having it
tested. As a college sophomore, Elizabeth Holmes envisioned a way to
reinvent old-fashioned phlebotomy and, in the process, usher in an era
of comprehensive superfast diagnosis and preventive medicine. That was a
decade ago. Holmes, now 30, dropped out of Stanford and founded a
company called Theranos with her tuition money. Last fall it finally
introduced its radical blood-testing service in a Walgreens pharmacy
near the company headquarters in Palo Alto, California. (The plan is to
roll out testing centers nationwide.) Instead of vials of blood—one for
every test needed—Theranos requires only a pinprick and a drop of blood.
With that they can perform hundreds of tests, from standard cholesterol
checks to sophisticated genetic analyses. The results are faster, more
accurate, and far cheaper than conventional methods. The implications
are mind-blowing. With inexpensive and easy access to the information
running through their veins, people will have an unprecedented window on
their own health. And a new generation of diagnostic tests could allow
them to head off serious afflictions from cancer to diabetes to heart
disease. None of this would work if Theranos hadn’t figured out how to
make testing transparent and inexpensive. The company plans to charge
less than 50 percent of the standard Medicare and Medicaid reimbursement
rates. And unlike the rest of the testing industry, Theranos lists its prices
on its website: blood typing, $2.05; cholesterol, $2.99; iron, $4.45.
If all tests in the US were performed at those kinds of prices, the
company says, it could save Medicare $98 billion and Medicaid $104
billion over the next decade.
What was your goal in starting a lab-testing company?
We wanted to make actionable
health information accessible to people everywhere at the time it
matters most. That means two things: being able to detect conditions in
time to do something about them and providing access to information that
can empower people to improve their lives.
There are a billion tests done every
year in the United States, but too many of them are done in the
emergency room. If you were able to do some of those tests before a
person gets checked into the ER, you’d start to see problems earlier;
you’d have time to intervene before a patient needed to go to the
hospital. If you remove the biggest barriers to these tests, you’ll see
them used in smarter ways.
What was your motivation to launch Theranos at the age of 19? What set you on this road?
I definitely am afraid of needles.
It’s the only thing that actually scares me. But I started this company
because I wanted to spend my life changing our health care system. When
someone you love gets really sick, most of the time when you find out,
it’s too late to be able to do something about it. It’s heartbreaking.
You’re not alone in your fear of needles.
Phlebotomy is such a huge inhibitor
to people getting tested. Some studies say that a substantive percentage
of patients who get a lab requisition do not follow through because
they’re scared of needles or they’re afraid of worrying, waiting to hear
that something is wrong. We wanted to make this service convenient, to
bring it to places close to people’s homes, and to offer rapid results.
Why the focus on rapid results?
We can get results, on average, in
less than four hours. And this can be very helpful for doctors and
patients, because it means that someone could, for example, go to a
Walgreens in the morning to get a routine test for something their
doctor is tracking, and the physician can have the results that
afternoon when they see the patient. And we’re able to do all the
testing using just a single microsample, rather than having to draw a
dedicated tube for each type of test.
So if I got a blood test and my doctor saw the results and wanted other tests done, I wouldn’t have to have more blood drawn?
Exactly. And on their lab form, the
physician can write, “If a given result is out of range, run this
follow-up test.” And it can all be done immediately, using that same
sample.
Todd Tankersley Brown Bird Design
Some conventional tests,
like pH assays, can be done quickly. Others, like those that require
culturing bacteria or viruses, can take days or even weeks. Are there
some tests that take Theranos longer? Can everything really be turned
around in four hours?
Yes, we had to develop assays or
test methodologies that would make it possible to accelerate results. So
we do not do things like cultures. In the case of a virus or bacteria,
traditionally tested using a culture, we measure the DNA of the pathogen
instead so we can report results much faster.
Where do you see this making a big difference?
Fertility testing is a good example.
Most people pay for it out of pocket, and it can cost as much as
$2,000. These tests provide the data you need to figure out someone’s
fertility, and some women can’t afford them. Our new fertility panel is
going to cost $35. That means women will be able to afford the tests.
They’ll be able to better manage the process and take some of the stress
out of trying to conceive.
What are you doing to ensure the accuracy of your testing?
The key is minimizing the
variability that traditionally contributes to error in the lab process.
Ninety-three percent of error is associated with what’s called
pre-analytic processing — generally the part of the process where humans
do things.
Such as?
Manually centrifuging a sample or how much time elapses before you test the sample, which brings its decay rate into play.
So how do you avoid these potential errors?
There’s no manual handling of the
sample, no one is trying to pipette into a Nanotainer, no one is
manually processing it. The blood is collected and put into a box that
keeps it cold. The very next thing that happens is lab processing, and
that’s done with automated devices at our centralized facility with no
manual intervention or operation.
How can improved processes actually save lives?
We’ve created a tool for physicians
to look at lab-test data over time and see trends. We don’t usually
think about lab data this way today. It’s “Are you in range, or are you
out of range?” Instead, we like to think, “Where are you going?” If you
showed me a single frame from a movie and asked me to tell you the
story, I wouldn’t be able to do it. But with many frames, you can start
to see the movie unfold.
How else can you use this technology?
Many, many years of work went into
making this possible. We started our business working with
pharmaceutical companies. Because we made it possible to get data much
faster, they could use our infrastructure to run clinical trials. They
were also able to run what’s called an adaptive clinical trial, where
based on the data, they could change the dosing for a patient in real
time or in a premeditated way, as opposed to waiting a long period and
then deciding to change a dose.
In the long run, what impact will your technology have?
The dream is to be able to help
contribute to the research that’s going on to identify cancer signatures
as they change over time, to help intervene early enough to do
something about an illness.
Will people become more used to gathering and examining their own health data?
No one thinks of the
lab-testing experience as positive. It should be! One way to create that
is to help people engage with the data once their physicians release
it. You can’t do that if you don’t really understand why you’re getting
certain tests done and when you don’t know what the results mean when
you get them back.
It drives me crazy when people talk about the scale
as an indicator of health, because your weight doesn’t tell you what’s
going on at a biochemical level. What’s really exciting is when you can
begin to see changes in your lifestyle appear in your blood data. With
some diseases, like type 2 diabetes, if people get alerted early they
can take steps to avert getting sick. By testing, you can start to
understand your body, understand yourself, change your diet, change your
lifestyle, and begin to change your life.
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