The Challenge of Blood Testing: From Theranos to Today

Blood testing is arguably the centrepiece of diagnostics in medicine. But a few years ago a scandal shook up the field, which still has consequences. The challenge now is to get over it but work towards its idea.

The Challenge of Blood Testing: From Theranos to Today
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About a week ago, on August 31st, Elizabeth Holmes’ trial finally started. She is the founder of Theranos, a startup that intended to develop a blood-testing device that could run diagnostic tests from a single drop of blood and put it into American homes. The company was valued at $9 billion at one point, and Holmes was praised for being the richest self-made woman and even dubbed the “next Steve Jobs”. Then The Wall Street Journal started digging into what holds true, and it turned out their technology was nowhere near what they were promising.

John Carreyrou investigates what was happening at Theranos in detail in his book Bad Blood, and I encourage you to read it. Here are a few quotes to give you a sense of what went down:

“The strange atmosphere got even stranger when the Theranos board convened once a quarter. Employees were instructed to appear busy and not to make eye contact with the board members when they walked through the office.”
In her relentless drive to be a successful startup founder, she had built a bubble around herself that was cutting her off from reality. And the only person she was letting inside was a terrible influence.
Theranos had cleverly played on this insecurity. As a result, Walgreens suffered from a severe case of FOMO—the fear of missing out.
But it had remained beyond reach for a few basic reasons. The main one was that different classes of blood tests required vastly different methods. Once you’d used your micro blood sample to perform an immunoassay, there usually wasn’t enough blood left for the completely different set of lab techniques a general chemistry or hematology assay required. Another was that, while microfluidic chips could handle very small volumes, no one had yet figured out how to avoid losing some of the sample during its transfer to the chip. Losing a little bit of the blood sample didn’t matter much when it was large, but it became a big problem when it was tiny. To hear Elizabeth and Sunny tell it, Theranos had solved these and other difficulties—challenges that had bedevilled an entire branch of bioengineering research.

I always have the story of Theranos in the back of my mind when I discover a new health startup. It demonstrates that some ideas are just too good to be true - a single drop of blood simply can’t be enough for relevant and reliable blood analysis yet. But the idea of being able to do a blood test from home is intriguing and, in my opinion, solves important problems. Not having to go to a clinic or lab for a simple blood test is better for both patients and medical staff. This is already regularly used by diabetes patients. Athletes use lactate measuring devices to follow their conditioning. This gives validity to Theranos’s idea - an all-in-one solution to analyse everything patients need from their home.

The first step of getting blood analysers to people’s homes might be point-of-care testing (POCT). POCT is diagnostic testing at or near the point of care, which is the time and place of patient care. So, instead of drawing blood, sending it to a biochemistry lab for analysis and waiting for the results, the doctor would do all of this in their practice in real-time.

There have already been significant advances in recent years, for example when you think about emergency medicine. Portable ultrasound machines and ECG monitors, while something ordinary today, made a huge difference. And there’s a lot more to cover and implement in this field, such as AI logistics and medical drones.

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However, in everyday medicine, we can’t afford to send doctors to people’s homes. We can, for now, just improve what happens at the point of care.

Genalyte is a company developing an efficient POCT system. Their technology is supposed to give results to doctors in less than 30 minutes after taking a venous blood sample. Their devices, Merlin and Maverick, can measure the vast majority of important blood biomarkers and more are on the way. The added value is in the integration of devices into clinical practice by also providing AI analytics based on the results.

While Genalyte improves how a venous blood sample is analysed, 1Drop Diagnostics uses a single drop of blood to run its tests and also improves the doctors’ workflow. This is similar to Theranos in terms of the technology used (microfluidics) and the idea of using a single drop of blood. So, in my mind, and I imagine in many other people’s minds, an alarm bell goes off. But it's also true that they published more than 22 pieces of peer-reviewed research and have more than 938 citations. They also claim to have tested almost 10,000 drops of blood, which leads me to believe they are improving and working toward a usable and reliable product.

1Drop analysis process

But these types of devices aren’t Theranos’s original idea. They aren’t meant to be used at home, so patients still need to visit their doctor. Some solutions though take care of this in a drastically different form.

These companies offer at-home blood tests, but with an additional step. They send a test kit to you, you send them back your blood sample and the results are visible in their app in a few days. Medichecks is one of those companies. You can choose from a wide variety of blood tests, from hormonal to lifestyle. The point is to make your home the the point of care without having to visit a clinic.

Medichecks and many other companies use the classic method of using a lancet to prick their finger and fill a tube to a certain volume. Everlywell takes it one step further as they developed their method of transporting blood samples to the laboratory. They use a piece of carton with a designated area for five drops of blood instead, which is a very simple and patient-friendly way of “drawing” blood. Their method has been tested and verified by comparing it with traditional analytical methods.

Everlywell test kits

As beneficial as this may sound, some questions need to be addressed. Firstly, the results heavily rely on the patient. They have to take the sample correctly and in some cases also arrange a courier to pick it up. Secondly, the way a sample is handled during delivery to the lab is crucial. Finally, this is simply not for everyone. Some are more comfortable with the technology, some less. Some patients can’t stand the sight of blood, which ironically is precisely why Elizabeth Holmes decided to start Theranos.

Looking at everything written in this issue, we can see that companies are approaching Theranos’s idea in two ways. On the one side, there are POCT devices for clinicians, some even using a single drop of blood to achieve reliable diagnostics. On the other side, there are at-home blood testing kits that are sometimes less elegant but made their way into patients’ homes. The intersection, however, seems unachievable at this time, maybe even because of what happened at/with Theranos.