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Scientists Are Skeptical About The Secret Blood Test That Has Made Elizabeth Holmes a Billionaire

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Faster, cheaper, better.

An innovation that accomplishes those three things has the potential to disrupt an industry. But such innovations are rare.

Theranos, a company founded by Stanford sophomore Elizabeth Holmes in the fall of 2003 (she dropped out a few months later) has generated a lot of buzz for developing a revolutionary approach to the blood test. Theranos’ innovation theoretically does clinical lab testing faster, cheaper, and, in some ways, better. Because of that, Theranos could upend the branch of medicine that provides the data used in roughly 70% of medical decisions.

That disruptive potential has already made Theranos famous and Holmes the youngest female billionaire in the US. But the more buzz Theranos gets, the more questions people seem to have.

When Holmes landed on the Forbes billionaire list in 2014, Theranos had raised $400 million, and the company had a valuation of $9 billion. Holmes owns about half of Theranos, with her worth estimated at more than $4.5 billion.

Holmes assembled a board of directors for Theranos that last year was described by Fortune magazine as “what may be, in terms of public service, the most illustrious board in U.S. corporate history.” Among those board members are a retired Navy admiral, a retired Marine Corps general, former US Sens. Sam Nunn and Bill Frist, former CDC director William Foege, former Wells Fargo CEO Dick Kovacevich, and two former secretaries of state, George Shultz and Henry Kissinger.

The caliber of the board suggests that Theranos must have developed a transformative innovation, but other than Frist, who has not practiced medicine in many years, only Foege is a medical professional. The technical details about Theranos’ seemingly revolutionary tests are hard to come by, and the company is known for its secrecy about its founder’s invention.

There’s one fundamental question, one that in some ways is unanswerable without revealing information that Theranos wants to keep confidential: How, exactly, does what Holmes invented work?

“It’s impossible to comment on how good this is going to be — it may be wonderful and it may bomb, but I really can’t be more definitive because there’s nothing to really look at, to read, to react to,” says Dr. David Koch, president of the American Association for Clinical Chemistry and a professor at Emory University.

We know enough to say that there is something promising about Theranos. People who have seen the company’s data are convinced of that. Holmes has teamed up with Walgreens to put Theranos labs inside its pharmacies (Theranos is in 41 of more than 8,000 Walgreens so far); Theranos has been conducting tests for GlaxoSmithKline and Pfizer and several hospital systems; it recently set up a partnership with Cleveland Clinic; and it earns revenue from the work it does for the US military, though Holmes has previously declined to elaborate on that, beyond saying that it’s an important area with the potential to save lives. Each lab is certified, and it can operate officially in a clinical capacity.

But Theranos hasn’t published peer-reviewed studies comparing its tests to traditional ones, and the company hasn’t allowed independent experts to publicly assess its labs, citing the need to protect its intellectual property.

The lack of peer-reviewed studies, the sort of evidence that scientists traditionally rely upon when looking at a development in their field, has generated skepticism from experts.

“They completely bypassed the traditional process of peer review or publishing in peer-reviewed journals or having peer labs evaluate their product,” says Dr. Jerry Yeo, a professor and director of Clinical Chemistry Laboratories at the University of Chicago.

Yeo says it’s normal for companies when they launch a new medical product to publish their results and allow experts to analyze their tests, especially as they become major players in the field.

“Why haven’t they shown us that information, why haven’t they been willing to publish it, and why haven’t they shown comparisons with existing technology?” Yeo says.

Theranos says it wants to protect the details of its unique product from its competitors, just as any company would protect an innovation. It also says it wants the Food and Drug Administration to evaluate its product to show that it works.

A representative for Theranos provided this statement to Business Insider:

The FDA, which is the ultimate arbiter of safety and efficacy — of high quality tests that are proven to work — is the gold standard, and Theranos wants its tests to be the best and safest for its patients. We have called for an unprecedented level of review with the FDA, something we are not obligated to do. We’ve been submitting all of our tests to them and are committed to continuing to do so.

Business Insider wanted to see what we could figure out about the science behind Theranos, even though it’s impossible to say definitively what the company’s technology is or how well it works without published data. However, we can study what Holmes has said about Theranos and look at the latest developments in related scientific fields. We spoke to experts in the fields of clinical pathology and laboratory medicine, biomedical engineering, and healthcare investing, all to see if Theranos really could have an approach to blood testing that’s faster, cheaper, and better.

This investigation raised as many new questions as answers.

The clues we have so far

Many of the headlines about Theranos talk about how Elizabeth Holmes reinvented the blood test:

Wired: “This Woman Invented a Way to Run 30 Lab Tests on Only One Drop of Blood
The New Yorker: “Blood, Simpler: One woman’s drive to upend medical testing
Business Insider: “This Woman’s Revolutionary Idea Made Her A Billionaire — And Could Change Medicine

But the details of Theranos’ technology aren’t what Holmes usually focuses on when she talks about the company.

When Holmes talks about transforming medicine, she talks about the idea that her system could eventually make it possible for people to more easily access data about their health by going and getting a cheap blood test on their own. Instead of just measuring our weight, we could also check our glucose levels.

We don’t know that having access to all that information is helpful yet, but many think that if we get better at interpreting the data, it could have huge effects on our health and help us catch disease sooner.

Still, whether or not easier access to blood tests could transform our health, such conversations don’t tell us anything about how Theranos’ technology works. Most of the time, Holmes says little about it. The New Yorker’s Ken Auletta described her explanation of what Theranos does as “comically vague.”

She told him:

“A chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result, which is then reviewed by certified laboratory personnel.” She added that, thanks to “miniaturization and automation, we are able to handle these tiny samples.”

More useful is something Holmes said in an interview with Fortune in June 2014.

As Roger Parloff wrote then:

Precisely how Theranos accomplishes all these amazing feats is a trade secret. Holmes will only say–and this is more than she has ever said before–that her company uses “the same fundamental chemical methods” as existing labs do. Its advances relate to “optimizing the chemistry” and “leveraging software” to permit those conventional methods to work with tiny sample volumes.

In other interviews she makes it sound more like she’s improving and streamlining processes while incorporating new but maybe not unheard-of technology.

She’s saying, essentially, that she’s come up with a way to optimize blood tests using chemistry, automation, software, and the latest in biomedical engineering.

An early academic interest might be the key

As an ambitious undergraduate (she worked in a Ph.D. lab her freshman year), Holmes expressed a lot of interest in what Auletta describes as “lab-on-a-chip technology, which allows multiple measurements to be taken from tiny amounts of liquid on a single microchip.”

This type of technology, microfluidics, has the potential to transform biomedical research by allowing people to glean meaningful data from minuscule amounts of liquid — in this case, blood.

The basic definition of microfluidics is “fluid flow in a channel that has a dimension of less than one millimeter,” according to Ben Moga, president and cofounder of a company called Tasso Inc. His company is working on a device that collects blood samples from people at home who attach the collection vessel to their skin with an adhesive so it can draw a clean sample. The ease-of-use factor, lack of big needles, and tiny amounts of blood involved mean the company definitely has something in common with Theranos — Tasso uses microfluidics to work with minimal quantities of blood.

It wouldn’t be possible to revolutionize the blood test and get away from big needles if you couldn’t use these tiny quantities of liquid.

Holmes’ first patent, filed before she started Theranos in 2003 and approved in November 2007, was for a technique to do multiple tests on a drop of blood. The term “microfluidics” appears in nine of the 31 patents that appear when searching the US Patent Office for “Theranos,” and she’s the co-inventor on more than 270 global patent applications.

Holmes may have the most ambitious ideas about how to use microfluidics technology, but she’s not the only one working in that field.

Others have developed quick blood tests using microfluidics before, including an IBM lab in Switzerland. Experts said that not only were these tests becoming more used in general, but that this sounds like exactly what Holmes and Theranos are doing, as it’s what she studied and what would make her blood tests possible.

In other words, the core technology behind the Theranos blood test might not be mysterious or even particularly new after all. But there are still some crucial missing pieces, especially since Theranos’ version sounds more powerful than anything else out there.

“The technology is emerging,” says the University of Chicago’s Yeo, and “some version of it is already out there.” But his question is whether Theranos could have really developed a way to run as many tests as it offers (more than 200 so far, with more to come) on the large scale needed at hospitals and in major labs without relying on already existing machines to automate processing.

Experts we spoke with said it seemed that running more than 20 or 30 tests from a drop of blood would be an impressive feat. Theranos is the first company to start using blood tests that primarily rely on microfluidics, and it says it gets unparalleled results.

“We can perform hundreds of tests, from standard to sophisticated, from a pinprick and tiny sample of blood, and we have performed more than 70 tests from a single tiny sample,” a representative for the company told Business Insider.

Moga’s company, Tasso, spun out of leading microfluidics expert Dave Beebe’s lab at the University of Wisconsin. More than a decade ago Beebe wrote that “microfluidics has the potential to significantly change the way modern biology is performed.”

Last year, in a review published in the journal Nature, Beebe and coauthors wrote that hematology, the study of blood, was one of the leading areas of use for microfluidic technology, though “a ‘killer application’ that propels microfluidics into the mainstream has yet to emerge.” Still, he wrote in that review that using this technology it was possible to use “microliters of blood from a finger prick” instead of “milliliters of blood from a vein” and process those samples in a few minutes instead of an hour.

This is cutting-edge technology, but it’s not exclusive to Theranos.

Others are working in the same area, even if no one else has launched a similar commercial effort. If Theranos is the company that has finally come up with Beebe’s “killer application” for microfluidics, that may explain its reluctance to show the patented details that make its technology unique, even though that rubs researchers the wrong way.

If, as Yeo says, a version of the technology is “already out there,” Theranos’ innovation may be that Holmes is the first to come up with a lab that implements a new form of that technology in an elegant and efficient way, putting it into action on a commercial scale for the first time in history.

Doing that successfully is a big thing. But while experts say that the company’s story is plausible, they want to know for sure that it works.

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Source: Business Insider


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