The Essenlix iMost blood test using iPhone technology for on-demand testing

Courtesy
Essenlix

• In the wake of Theranos — the buzzy blood-testing
  unicorn that’s
  fallen from grace and whose
  founder faces criminal charges — startups are still working
  to make blood-testing faster and cheaper. 
• One new startup called Essenlix uses an iPhone and an
  attached device to run tests like a complete blood count, used
  to measure red and white blood cells in the
  body. 
• The device, not yet approved, could bring blood-testing
  technology to more people who might not have access to a full
  lab. 

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The story might sound familiar: An entrepreneur out of a
prestigious US university has developed a new blood-testing
technology that can be run using only a small sample of
blood. 

While that might leave visions of black turtlenecks, and Silicon
Valley-level valuations in your head, Stephen Chou, a professor
of electrical engineering at Princeton University, is trying to
make sure his startup, Essenlix, doesn’t meet the same fate as
Theranos. 

Professor Stephen
Chou
Courtesy
Essenlix

The New Jersey-based company is developing a a system that uses
an iPhone and an attachment to run lab samples on-the-go. 

“You basically have a mobile chemical biological lab in your
hand,” Chou said. 

To start, Chou developed a test for a
complete blood count (or CBC), which measures the number of
white and red blood cells in the body as well as hemoglobin, a
protein responsible for transporting oxygen.

While the test is used to monitor overall health, it’s also
frequently used in blood cancer practices to check a
person’s blood count before chemotherapy. The company’s
raised about $20 million from investors including
Quadrant Management, Carret Private Investments, and other
high net worth individuals. 

Here’s how it works

Essenlix’s system, dubbed the iMOST (short for “Instant Mobile
Self-Test”), consists of a few different components: there’s an
app, an attachment, a cartridge for the sample, and of course the
iPhone itself. The attachment sits over the iPhone’s camera and
flash. 

Lydia Ramsey/Business Insider

The test starts with a finger-prick. The first drop of blood gets
wiped away, but the second gets put on a thin plastic
cartridge. 

Lydia Ramsey/Business Insider

Once that’s done, the cartridge is loaded into the green
attachment, and the test is run in a matter of seconds,
leveraging the insides of the iPhone including the flash and
camera. 

Lydia Ramsey/Business Insider

Typically, complete blood count tests are done on machines found
in the labs at doctor’s offices. To vet Essenlix’s system, the
team ran clinical trials comparing the new technology to
traditional devices. 

In two trials of 92 patients total run at Hunterdon Hematology
Oncology in New Jersey, Essenlix tested patients with both the
standard machine and its blood test. In the end, there was on
average a 6% difference between Essenlix’s white and red blood
cell counts and what traditional machines found, and a 3%
difference in hemoglobin measurements, all within the FDA
requirements for
allowable total error.

“Our error is clearly smaller than the FDA’s requirement so the
data is very, very good,” Chou said.

With that data, Chou said the company is working with the FDA to
move toward a potential approval, and ideally hopes to publish
the clinical trial results in a publication. 

Proliferating lab testing

While doctors who already have access in their offices to a lab
that runs blood count tests might not need an iPhone-based
version, the implications of a mobile testing platform could be
significant in rural areas that may not have access to
traditional, expensive equipment. And ultimately, because the
test can be run rather simply, it might lead to lower lab costs.

There are others companies trying to make the blood testing
process easier and cheaper. In July, a company building a
tabletop machine got the
European OK for its CBC tests.

The lab-testing community is optimistic for a day when tests like
a CBC can be run on smaller, more portable machines, which will
inevitably improve access to the technology. 

“This is necessary,” Dennis Dietzen, a medical director at St.
Louis Children’s Hospital and professor of pediatrics and
pathology and immunology at Washington University School of
Medicine and president of the American Association for Clinical
Chemistry told Business Insider. But miniaturizing the technology
needed to run these kinds of tests, Dietzen said, isn’t easy.
Dietzen said he’s still waiting to see clinical data published in
an academic journal that compares Essenlix’s technology to the
standard way blood tests are run. 

The dearth of clinical data and published articles about its
technology was a
common refrain for criticism to Theranos. For a long time,
the company didn’t publicly share its data, saying it’d rather go
through the FDA approval process. 

In the future, the hope is to use Essenlix’s iMOST technology for
other blood tests to detect viruses or bacterial infections, and
ideally one day on other types of body fluids
beyond blood.  

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