Policy Innovations Digital Magazine (2006-2016): Innovations: Bye, Doctor, Hi, "Cloud"

Non-invasive, cheap, fast, and personalized are not usually the adjectives used to describe today's diagnosis methods. But what if we could really change the game? A group of entrepreneurs has created Miriam: a 3D-printed device that could detect dozens of different types of cancer and other diseases in less than an hour, using only a drop (1ml) of blood, a well-plate, and a smartphone. Yes, they are turning the out-of-date diagnostic industry upside down; and they are not afraid.

IRENE PEDRUELO: Some decades ago it seemed it was a golden moment for the computer industry. Everyone was talking about Steve Jobs, Bill Gates, and others starting a revolution. Now it seems we are talking about biotech in similar terms. What should we expect from this biotech revolution?

ALEJANDRO TOCIGL: Today, biology is converging with technologies such as artificial intelligence, nano-technology, high capacity of computing, etc. This convergence is leading us to a revolution, so-called biotechnology. Before, the biggest advances happening in the medical and scientific fields were mainly driven by big pharmaceutical companies or research centers. It was an isolated industry. Whereas today, many emerging companies and start-ups are trying to disrupt the field and the existing traditional approaches to innovation.

IRENE PEDRUELO: You are one of those disrupters. Last October at TEDGlobal your team introduced Miriam, a 3D-printed low-cost device to the world . Miriam is able to detect dozens of cancers with a single blood test in less than an hour. Why hasn't rapid, affordable, and early diagnosis been available before?

ALEJANDRO TOCIGL:Miriam detects the presence of microRNA (miR) in the blood sample. It's only in the last five years that thousands of scientific papers have been published correlating certain microRNA patterns found in blood samples with specific diseases.

IRENE PEDRUELO: What does microRNA refer to?

ALEJANDRO TOCIGL: MicroRNAs are biomarkers that regulate gene expression. Unlike DNA, which is mainly fixed, microRNA can vary depending on internal and environmental conditions. This means that over your lifetime you will have different patterns or expressions of MicroRNA. So, having MicroRNAs is like having a real-time monitoring system in your body!

IRENE PEDRUELO: If microRNAs behave almost like biological signs that warn us about what is happening in our body all the time at the molecular level, how does Miriam play into all this?

ALEJANDRO TOCIGL: Miriam is just a device connecting two very important parts of our company. The first and most valuable one: a very smart biochemistry. And the second one: the cloud. What the device really does is to create the optimal conditions for the reaction to happen. Whenever the microRNA we are looking for is present in the blood sample, the trap on the plate closes and it shines with a green color. Then it sends the information that is coming from the reaction to the cloud.

IRENE PEDRUELO: The first prototype for Miriam incorporated the use of a smartphone that seemed to be acting almost like a dark chamber or a photo booth, taking pictures of the plate where the reactions are happening.

ALEJANDRO TOCIGL: The smartphone was both a connected computer and a camera. It had a specific app incorporated in it, which was taking pictures of the reaction every minute while it was happening, and sending that information to the cloud. In the cloud, we have algorithms that correlate what we found with the existing scientific documentation on microRNAs. The smartphone is just the way to send the data to the cloud.

IRENE PEDRUELO: You recently came up with a second prototype that doesn't incorporate the use of a smartphone. Why?

ALEJANDRO TOCIGL: Instead of a smartphone, we now use sensors, which are even more sensitive to the reaction than a camera. The information is sent via Bluetooth or Wifi to a device connected to the cloud for the data collection and analysis.

From left to right Miroculus founders: Jorge Soto, CTO; Fay Christodoulou, CSO; and Alejandro Tocigl, CEO.

IRENE PEDRUELO: Is Miriam not only able to diagnose an illness but also its severity or even how a patient is responding to treatment?

ALEJANDRO TOCIGL: Miriam itself is just a device. The assay is called Catchme, and the company is called Miroculus. The intention of Miroculus is not just to test, but to be a surveillance platform that is constantly monitoring how your body is reacting to a specific situation. The good thing about microRNAs is that they are not just a diagnostic biomarker but more and more you find papers and publications showing the relevance and the potential that they have as a prognostic and as predictive biomarkers. They can tell you how your body is reacting to a specific treatment, and in the future you will be able to predict how your body will react to a specific treatment depending on the disease. That is the ultimate goal. We don't want to be a test you take once a year or once every couple of years, but hopefully something that is constantly monitoring you and the illnesses you may have.

IRENE PEDRUELO: You just said, "It's a surveillance platform constantly monitoring how your body works." Saying it out loud sounds scary to me.

ALEJANDRO TOCIGL:If you have a disease, you really want to know how that disease is evolving, and how the treatment is actually working in your body. If you don't monitor it, when you discover it's going in the wrong direction it could be too late.

IRENE PEDRUELO: How well is Miriam able to explain how your body is reacting to a specific treatment?

ALEJANDRO TOCIGL: There is a lot already published and validated about using microRNAs as a diagnostic biomarker. The study of biomarkers in blood for prognosis and prediction, however, is still very new, but because of its potential, it is growing. Miroculus is a working project. It's not a platform you can have in a hospital yet. We are still in the developing process, and we will be for at least the next 15 months.

IRENE PEDRUELO: Some people have raised concerns regarding the potential for over-diagnosis of benign cancers that devices like Miriam could trigger.

ALEJANDRO TOCIGL: I know the concern exists, and we don't want to make people scared. We don't want to turn into a paranoid society living in constant fear, but there are some things that are important to know, and having cancer is one of them. If I get diagnosed with cancer, I would be continuously monitoring myself: often if it's a fast growing cancer, and less often if it's a slow growing one.

IRENE PEDRUELO: Scientists and technology companies like yours often give TED Talks and announce that they are on the path to save thousands of lives, etc., but it usually takes a very long time for this to happen, if it ever happens! Many times citizens don't get to experience such a revolution in their daily lives. Are you, innovators, over-optimistic? Is the industry really ready for change?

ALEJANDRO TOCIGL: And another question could be: Why isn't it changing as fast as we think it should? This is just the beginning. It will change. Today there are many things that are stopping the industry from changing, such as regulations, the insurance industry, the U.S. Food and Drug Administration (FDA), the power of big companies that have established a distribution channel that is so strong that it's very difficult for small companies to get in, etc. This is just the beginning of the revolution of the biotech industry. Even if it hasn't changed much for the end-consumer yet, it will be changing radically in the next five to ten years.

IRENE PEDRUELO: If you had to envision how the health industry is going to work in the future, what would you say? How is the game going to change?

ALEJANDRO TOCIGL:It's a much larger conversation, but I envision it as being very different to what is today. I envision it as much more personalized or customized. Once when I was younger, I went to a doctor because I was feeling sick. They gave me a pill, I took it, and three hours later I was back in the hospital, because I had had an anaphylactic shock, which happens when you are basically allergic to something. I asked the doctors how they could possibly have given me something that could do so much harm to my body, and their answer was: "How could we have known?" That memory stayed with me for years: how is it possible that treatment and diagnosis today is so generic? With microRNAs we try to understand the body at the molecular level, which is very different from what we have been doing.

IRENE PEDRUELO: One of the words that Miroculus uses frequently is "democratizing." Your purpose is to "democratize" access to health. It sounds like a very nice concept but why would having Miriam in everyone's hands be better than having it in a lab?

ALEJANDRO TOCIGL:"Democratizing" refers to the fact that it's very affordable. It's not only affordable in price, but also very easy to use. You don't need a high-skilled scientist to be there for the reaction and you don't need a well-equipped lab to handle this operating platform. Also, we are not planning to have it everywhere nor in everyone's hands. Our idea is for Miriam to be in every hospital and it would provide information to the doctor that he or she could pass on the patient.

IRENE PEDRUELO: You are facilitating access to diagnosis, but we know that in many countries people have no access to the treatment.

ALEJANDRO TOCIGL: This company won't just target the richest people in the world, those who can afford running expensive tests. Hopefully it will be available to everyone in developed economies and also in emerging economies, where we believe the platform has the potential to expand. But we're not thinking about countries that couldn't do anything about a disease even if they had the information. We are thinking about countries where there is already access to treatment and where this information can help.

IRENE PEDRUELO: The idea that early detection equals lower mortality rates is almost a mantra in the field. It seems a very intuitive concept, but there is some research that if not contradicting it, at least questions this assumption.

ALEJANDRO TOCIGL: Many organizations from all over the world are saying that we shouldn't leave the battle against a disease to treatment alone, but also to prevention and early detection. As you say, there is some controversy around this assumption, but I personally would much rather have the information first and decide on the best way to treat it, rather than not having it and then seeing myself in stage four cancer.

IRENE PEDRUELO: What are the obstacles you are facing right now in the development phase?

ALEJANDRO TOCIGL:We have a working prototype. We've proved we are able to detect microRNAs in a technical and biological way. In the next few months, we need to get the clinical validation of our platform conducting clinical trials. A cancer research center donated 200 samples with metastatic cancer that we are using to test our platform. After that we will need to start another round of fundraising that will be more focused on how we get the platform to the markets, i.e. getting it regulated, and envisioning how we are going to take it to different countries.

IRENE PEDRUELO: You are operating as a Silicon Valley start-up. You have angel investors, you participate in seeding rounds, etc. How is your business going to be sustainable over time?

ALEJANDRO TOCIGL: We are still in the product development phase, so we have not proved our business model yet. But our hypothesis is that the primary source of revenue will come from the assay or well-plate itself. Miriam, the device itself, will be cheap to buy. Then we will sell the assay in a constant basis, and eventually we will have gathered a lot of data in our servers. This will allow us to improve the algorithms and have better conclusions on diagnostics or on how your body is reacting to a specific treatment. We define ourselves as a data company rather than a hardware company. We are not trying to have a huge amount of mediums. The data will probably become the most valuable part of our company.

Policy Innovations' Eight Quick Questions

Where do you see yourself in 20 years? No idea. I don't even know where I'll be in five years.

What are the three main attributes of an innovator?Bravery, honesty, and craziness.

What other obsessions do you have in addition to fighting cancer?Many. One: how to decentralize cities and countries. We have such an amazing opportunity to improve our quality of life outside the cities.

What does social innovation mean to you?Creating value in a different way that has a positive impact on society.

What do you do in your free time?Surfing and whale watching. I love nature.

Finish this sentence. I am afraid of . . .the power of technology (handled by people with bad intentions).

Life is about . . .definitely about having fun while doing something you care about.

What would you tell your younger self if you had to start over? Be crazier.