Why Theranos’ blood-testing machine failed so hard

The fall of Theranos is a story of biting off more than you can chew. Also, hundreds of millions in fraud.
Image: HBO

Theranos is dead. 

But will the dream of a device that can analyze multiple health factors from a small amount of blood be buried along with it?

What Theranos founder Elizabeth Holmes was proposing, as outlined in the popular HBO documentary about her ill-fated, fraudulent company that aired this week, was scientifically impossible. She told the world she could run 200 tests on a fingerprick-worth of blood using a device she called the Edison, but The Inventor: Out for Blood in Silicon Valley reveals she faked the impossible, putting patients’ lives at risk.

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The extent of the Theranos grift is so gargantuan, its effects are still rippling even after Holmes was first caught lying in 2015.

There are dozens of other companies working on similar, if less-sweeping projects, that involve re-thinking diagnostic blood testing. But the stench of Theranos’ fraud is now getting on them all, and making it more difficult for legitimate projects to raise money from investors.

“The reputation was so bad that everybody would run the other direction if they thought you were doing something like what Theranos was doing.”

“Understand that for the last four years, anyone that’s been talking about point-of-care diagnostics in front of investors has had to say ‘and we’re not like Theranos,'” Dr. Paul Yager, the former director of bioengineering at the University of Washington, said. “The reputation was so bad that everybody would run the other direction if they thought you were doing something like what Theranos was doing.”

Yager is an expert in “microfluidics,” which he describes as the “field of research and engineering that involves itself with moving small volumes of liquid for any purpose, including medical diagnostics.” Under grants from the Bill & Melinda Gates Foundation, the National Institute of Health, and the Defense Advanced Research Projects Agency, Yager has been developing portable tools to test small amounts of blood for diagnosing diseases to use particularly in the developing world.

The problem with Holmes’ Edison wasn’t necessarily the underlying idea of portable, low-impact, point-of-care testing. Using a small amount of blood to run diagnostics for one or more conditions is a reasonable idea, Yager said, within limits. Innovation in microfluidics is leading to progress in this field and a better understanding about what can be done with a small amount of blood. But oversized ambition and purposefully ignoring scientific and tech realities caused Theranos to fail — muddying the waters for everyone else. 

“There are real home tests for a variety of conditions in the U.S. domestic market that are based on microfluidics,” Yager said. “But none of them is following the Elizabeth Holmes model at this point. In fact they’re running away from it as fast as possible.”

Theranos leadership appeared not to acknowledge several constraints, or at least thought they could work around them through a combination of magical thinking and endless technological development. The documentary features multiple Theranos employees explaining how they tried to tell leadership the Edison wasn’t working, but to no avail. Holmes raised $400 million and hooked a lucrative contract with Walgreens, rolling out blood draw centers in Arizona even though the Edison was inaccurately analyzing patients’ blood. 

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The Edison’s first and largest problem is that a fingerprick-worth of blood is insufficient for testing a variety of conditions. There are a finite number of molecules in any given amount of blood. Some condition markers (like glucose levels) have a high presence within any amount of blood. But others, like certain markers of infectious disease, are less prominent, meaning that a small amount of blood won’t give an accurate reading. 

“It depends what kind of test you are running,” Dr. George Yaghmour, a hematologist at USC’s Keck School of Medicine, said. “Platelet count, kidney function, liver function, sodium level, electrolytes —basic stuff. It would be doable, you don’t need much blood. But if you talk about culture and infection, then you need a specific amount of blood.” (Yaghmour is involved in a clinical trial in which patients provide a small droplet of blood to an at-home testing kit in order to test blood platelet levels. He declined to provide further specifics about the trial due to confidentiality.)

Theranos promised the Edison could screen for multiple infectious diseases, like HIV and syphilis, but results were inaccurate. At many Theranos centers at Arizona Walgreens, phlebotomists ended up drawing more blood than advertised with a needle and back at the Theranos lab, technicians leaned on commercially-available blood testing equipment — just like competitors. 

Another selling point, and constraint, of the Edison, was its size. The device that would take in blood samples, run tests, and display results would theoretically be the size of a home appliance that could sit on a counter top. It turned out that it was impossible to build a device of that size to run 200 tests. And yet, Theranos leadership was married to the compactness of the Edison despite pushback from employees.

So if you’re running fewer tests than Edison’s proposed 200, is it possible to get accurate test results from a device of this size?

Yager was optimistic on this front. Engineers and biochemists (Yager estimated about 30 companies) are actually currently inventing devices intended for portability and use outside of a lab setting. Yager’s current work involves one testing kit that’s the size of about a pack of cigarettes, though, of course, the diagnostics are limited to testing for certain diseases, such as influenza, ebola, and zika virus.

“This isn’t a pipe dream,” Yager said. “It’s just that you need to be clever about what you’re doing, you need to have real IP.”

But what about Holmes’ idea to put blood test results in patients’ hands — letting them interpret them without a doctor’s help. This, again, depends on just what you’re testing for, and who’s being tested. Yaghmour is enthusiastic about the prospect that his patients would be able to take tests and monitor their conditions at home, without the need to come in.

“I’m excited about this method, especially for patients who live far away from my centers,” Yaghmour said.

On the other hand, Yager said technology may not be advanced enough to eliminate the need for human interpretation and care. In order to provide a full spectrum of care, diagnostics would have to combine with AI in order to take a patient’s history and current condition into account, along with diagnostic test results. 

“There is a reason we spend a lot of money training our doctors, and then we give them years of experience to do things,” Yager said. “That is that health isn’t just about the test, it’s about the test in context, and understanding the context and the life of the person is really critical to making diagnoses in most cases.”

Doctors and researchers at more proof-focused organizations like the National Institute of Health, are still working to innovate blood tests. What’s more, many researchers were studying how to unleash the potential of a drop of blood long before Holmes was on the scene.

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“She wasn’t a leader, she was a follower,” Yager said.

Not only that — as the documentary shows, she was also a liar. 

Original Article : HERE ; This post was curated & posted using : RealSpecific

This post was curated & Posted using : RealSpecific

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