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Theranos

Theranos’ Biggest Crime is Casting Doubt on Consumer Diagnostics

Did Theranos Swirl Cast a Shadow on the Entire Sector? Not So!

Photo Credit: Gorodenkoff — istock photo by Getty Images

On the front pages of the business press and in the top stories on broadcast news, we are seeing a lot about Elizabeth Holmes and Theranos. While it’s important that the trial uncover the truth, one casualty of the Theranos scandal is that the idea of convenient, more accessible, diagnostic blood tests has been potentially disadvantaged. The fact is, we need great, consumer-focused, diagnostic care, which leads us to definitive answers around patients’ risk of disease and the ability to stay on top of chronic conditions. Where is the technology today and what can be done to overcome the skepticism among consumers and investors that Theranos has caused?

Dr. David Stein, CEO of Babson Diagnostics, is a recognized leader in the diagnostics innovation category. Dr. Stein has been a pioneer working with medical technology giants such as Siemens Healthineers, Roche Diagnostics, Becton Dickinson, other leading global companies on the field of consumer care diagnostics. What does one of the sector leaders believe is the line between imagination and reality — between sales and science?

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Gil Bashe: We are all following the Elizabeth Holmes trial closely. It captivates us. While there is a lot of debate focused on the person in the spotlight, we all agree that Theranos had a great idea. I think the real question is, “can a drop of blood give us THAT much information?” Dr. Stein, you’ve been at the forefront of looking at this. Is it possible?

Photo Credit: Babson Diagnostics — David Stein, PhD, David Stein is Chief Executive Officer and Director, Babson Diagnostics, former global head of strategy and president of molecular diagnostics for Siemens Healthineers, and Board Chairman of PixCell Medical.

Dr. David Stein: When I first started in this field 20 years ago, people asked if we could do broad panels from small volumes of blood. That was always a goal that everybody was trying to attain. We looked at a very narrow menu based on capillary samples or those that were easy to collect. Then in 2015, we started asking if technology had evolved enough that you could do broad panels from small volumes of blood.

I’m not saying one drop; I’m saying a few drops. We saw that it was possible, but you couldn’t do it via point-of-care locations. You had to totally reimagine the end-to-end process, from collection to the way we automate, making it easier for the person collecting a sample to do the pre-analytics, to the way you maximize the clinical utility of the blood you collect. Then, you need to consider how to approach the analytics, so you get economies of scale and breadth of menu.

In short, the answer is “yes.” From a small volume, it’s possible; however, only through taking a very rigorous, science-first approach and reimagining the end-to-end process can it be achieved.

Did Theranos Cast a Shadow on the Entire Sector?

Bashe: Dr. Stein, you seem so clear that it’s possible, it’s doable. I know, looking at the science that you’re championing, you are demonstrating successful results in large numbers of people. So why did Theranos fail? Where did they go wrong? Can you explain that for us?

Stein: I will not claim to be an expert on what Theranos was doing nor how they approached it. What I do know is how we are approaching that same challenge. We’ve had the great opportunity to partner with Becton Dickinson and Siemens on this journey and really break down this problem from collecting a very reliable, small sample of blood from somebody’s finger to automating all the analytics around it.

When we looked back at when Theranos was doing this, I think it is likely they tried to pull together discrete technologies to make this happen and you can’t do that. Everything has to fit together seamlesslessly. If you look at methods for hematology, comprehensive metabolic panels, immunoassays, lipids, there’s a gold standard, and that’s what we’re adhering to. We’ve looked at how you maximize the clinical utility of the blood you collect and how, on the analytic side, you can use less blood volume to do these broad panels. There are no dilutions or cheats or anything like that in what we are doing. We’re truly using global, gold-standard methods.

Why Consumer Blood Test Matter and How Convenience Saves Lives

Bashe: We’re all occasionally guilty of not following through. A doctor writes a prescription, tells us to go to a phlebotomist or a diagnostic center. Then one year later, we still haven’t done it. What’s the danger of that? Can you talk to us a little bit about the imperative, the importance of timely blood testing?

Stein: We’re doing what we’re doing largely for this reason — to hopefully, help people have a longer lifespan. For me, this is a deeply personal mission. More than 70% of all clinical decisions are informed or powered by diagnostic lab testing. But as you’ve mentioned, a lot of people don’t get it done. What we’ve seen in this new economy is that people want choice. They want convenience. They want to be empowered in their health journey. We believe people should have convenience and accessibility when it comes to their diagnostic blood testing without having to sacrifice quality, menu breadth, cost or any of these aspects.

With the rise of telemedicine, you can sit with your doctor, with your blood tests in front of you and say, how do they look? How could I improve results? Just by looking at somebody, you can’t tell how healthy they are, but a blood test gives you an incredible amount of information about their metabolic state and other risk factors. I can tell you that somebody who’s pre diabetic can take actions a lot more effectively than if they have diabetes already. It’s the same for other diseases. That’s the goal of everything we’re doing: make the information accessible and timely so that your clinician can take action and you can treat conditions before they become chronic disease.

Everybody wants a long life, but the most important thing is that you enjoy a healthy life. That’s my mission: make diagnostic blood testing more accessible and convenient so people can be empowered to take hold of their health care journeys.

Bashe: When we look at take-home COVID-19 antigen assay tests, we’re seeing how easy it is for consumers to engage. Correct me if I’m wrong, but it’s really high-tech made very simple. To your point, I think consumers want to be involved in conveniences that this Amazon-like economy makes possible. The possibility of me easily taking that blood test where I pick up shampoo or prescriptions is very appealing. Share some thoughts about the process that that you imagine for putting into practice convenient diagnostics at the consumers’ point of purchase — a process that Theranos clearly wanted to pursue.

Stein: Retail in general is a great place to get diagnostic blood testing done. Pharmacies are trusted places; when you walk or drive by one, why couldn’t you get your diagnostic blood test done? COVID testing showed that retail is a preferred, convenient way of getting health testing handled. Most COVID testing was done by going to the pharmacy quickly and getting results that day or the next.

That is our approach: a consumer-focused, health-system-compatible path. Go to your pharmacy. No HIPAA or payment going back and forth. It’s transactional, accomplished within five to seven minutes by a pharmacy tech or customer care representative. A phlebotomist doesn’t need to be onsite. The process would be completed using a device we are developing in concert with Becton Dickinson. The pharmacy customer’s sample would go directly into a small device that automates all pre-analytic processes and does everything according to the medical chain of custody. Then once a day, or multiple times a day if volume requires, couriers pick up samples and brings them to a highly automated microsample lab. Patients and providers get results that day or the next. We plan to offer a broad menu of tests, so this service covers what you need for your routine testing.

Bashe: I want to go back to the Theranos situation. The book has come out. The trial is happening. Countless newspaper articles are being written. in the wake of all this reporting and speculation, a core concern is the possibility that the technology has been disadvantaged because people are looking at it through the lens of the Theranos failure. When there’s so much public health need for this idea to be realized, what are you and others doing to overcome communal skepticism?

Stein: The need for accessibility and convenience is real. People want it. I think the no-brainer is that our work is driven by science. We made a very conscious effort to always lead with science, always lead with transparent data. We have a scientific advisory board made up of luminaries in the industry to ensure that we always follow the science. I feel like my first 20 years in diagnostic science and patient care was to help me advance the category to this point. It’s not just me. The leaders of the category are also dedicated to addressing patients’ needs and bring advances to market. But we cannot do that by side-stepping the science.

First and Foremost Validated Science

Bashe: Despite the shadow Theranos cast on the sector, there are a core group of dedicated companies working on blood diagnostics, and that’s a huge public health benefit that investors are recognizing. Among those companies, you are clearly a front runner. You have the right partners, have the science behind you, published peer-to-peer data, you’re developing partnerships: it’s all very exciting. Let’s look at the future for a second. Can you give me a sense, without committing, when you think we could see this in the market? And what are your next steps?

Stein: I won’t give you a definitive timeline because we’re a regulated industry and science is something we take seriously; you can’t push it. The data have to support the concept. I can tell you that we have about a dozen people coming in through our retail partners directly to our facilities each day when we’re running clinical studies and we’re constantly running clinical research with retail partners. Having been in diagnostics for two decades with leaders such as Eric Olsen and industry pioneers as partners, we know we need to be in the field, testing people. That’s what we will continue doing between now and launch, which will be sooner than later. With retail partners, we are ensuring that when a patient walks into a retail space, they have an incredible customer experience, that the collection process is easy and intuitive for all sides, and that people truly get their results same day or next day.

Bashe: I’m glad to see that, in the wake of the Theranos controversary, you and your amazing partners are mobilizing the technology and essential science to address a pressing public health. You’re providing further proof that by engaging the consumer, we have the best chance to use technology to benefit people. I want to thank you and the Babson Diagnostics community for doing your part. Thank you for clarifying the differences between imagination and reality when it comes to consumer-centered testing, and reminding us success is dependent on good science, transparency, and staying true to the regulatory process.

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