SomaLogic is currently in the process of building in real time what CEO Roy Smythe, MD, describes as “a market for a new class of diagnostics.” Those diagnostics, of course, are based on the company’s proteomic platform, which is slated to cover more than 10,000 proteins in the near future.
Smythe joined SomaLogic as Chief Executive Officer in 2018. Prior to that, he was Global Chief Medical Officer for Strategy and Partnerships at Royal Philips, Chief Medical Officer at Valence Health and Chief Medical Officer at the technology accelerator, AVIA. Smythe also served as a surgeon, biomedical scientist, academician, health system administrator and entrepreneur.
Health Evolution interviewed Smythe about SomaLogic’s roots in the science of measuring proteins, 15 years of hard-fought science, partnering with Intermountain Healthcare, CommonSpirit Health, UPMC, University of Colorado and Emory on precision health initiatives and more.
What is the origin story of SomaLogic or the inspiration fueling the company?
Smythe: It’s a really interesting story, actually. We just went public after being a private company for 20 years. The list of life sciences tools and diagnostics companies that have survived two decades without going to Wall Street is tiny.
The founder of the company is Dr. Larry Gold, who just celebrated his 80th birthday. More than 30 years ago, he discovered the science that underpins the way we measure proteins. He was an RNA biologist and knew that pieces of nucleic acid bind to proteins and cells and that they did things biologically that were important, and he wondered: Why can’t I just engineer little pieces of nucleic acid to bind to proteins so that I can use them to identify and measure proteins? Maybe there’s a therapeutic potential there? So he created a therapeutics company on one of these little pieces of DNA to treat macular degeneration and that drug is still being used today.
That earlier company was eventually sold, and he used some of the proceeds to work on another project – one to better identify and quantify proteins using this new class of reagents, and to also understand all the things that could illuminate. Larry Gold knew 30 years ago that proteins can be a huge information source to power medicine. Then it turned into a 15-year, highly technical science project to first make these protein measurement reagents and then to create an assay that can measure thousands of proteins simultaneously in complex mixtures like blood. It was 15 years of hard-fought science.
The vision has always been to take protein data to make human health and health care better. We’re just now at the point where we can actually do that. I came in two years ago to help mature the company I’m working to structure the business so we can put these tools in people’s hands, for both our biopharma and research clients as well as clinicians. We want to create a new class of diagnostics. And, of course to secure the funding to continue this work, which is no easy feat and never guaranteed.
Why are proteins key to effectively monitoring, treating and preventing disease?
Smythe: Only about five to ten percent of diseases are driven primarily by the genes you were born with. Everything else is driven by some sort of genetic predisposition that probably involves many genes acting together as well as the things that you’re exposed to, so you’ve got more than 90 percent of disease that’s really not determined by genomics alone.
There’s a whole host of things that proteins can tell you about in real time that genes can’t tell you anything about. Even if we identified an obesity gene, that gene doesn’t tell you anything about how much you currently weigh, or your percentage of body fat. Your proteins are constantly changing, but your genes are static. There are 20,000 protein structures in the body and if you can measure enough of them, and then make sense out of the data, there’s all sorts of interesting things you could predict. Proteins are the structural and functional molecules of life.
We currently measure 7,000 and are moving toward 10,000 of those canonical 20,000 proteins. We can do it in a highly reproducible way and artificial intelligence and machine learning can help us look at the data and understand what’s going on in the moment and what will happen in the future.
What are the key therapeutic areas that you see the most opportunity for in the next year or year and a half?
Smythe: In the next year to year and a half, I would say the therapeutic areas that we are likely to have the most impact on are the areas in which we’ve already developed highly complex protein pattern recognition tests. It’s important to know that these tests are not like regular protein tests where you measure one protein – our tests have between 16 and 360 proteins in the models. For example, there’s a combination of proteins in your blood that can predict whether you are at risk of a heart attack or stroke over the next four years, and the way we found the right combination is by measuring thousands of proteins at once and then using machine learning to tell use which ones were important.
The clinical area in which we’re likely to have the most impact in the next couple of years is cardiac and metabolic diseases. Cardiovascular risk, CHF risk and MI, risk of stroke, diabetes risk and risk of secondary complications from diabetes. And then some tests that also would go along with that like percentage of body fat, cardiorespiratory fitness and lean body mass. You can answer all those questions from a blood draw. Take VO2 max, which measures the amount of oxygen you use. It requires that you get on the treadmill and exercise to exhaustion with a mask on. I have a son who is in the NFL and when I told him we could do that VO2 test from a simple blood draw, he wanted to know how much it costs because he would be more than willing to pay for it at the beginning of training camp every year, to avoid that treadmill test.
We have renal tests that are coming, we have tests to predict your biologic risk of developing cancer. These should be available in the next year. We have respiratory disease and neurological disease tests coming to determine a person’s chance of developing or experiencing an exacerbation of emphysema, or developing diseases such as Alzheimer’s or other cognitive decline. All those things are in our pipeline.
Roy Smythe, SomaLogic
What are you looking for in potential partners for SomaLogic?
Smythe: We have already initiated many partnerships and there are others we need in order to take a new clinical product into the market. We have five health systems so far in our Proteomics for Precision Health Initiative: Intermountain Healthcare, CommonSpirit Health, UPMC, University of Colorado and Emory. That’s just a start. These health system partners will be evaluating this new class of diagnostics: Do they make clinicians more efficient? Do they save money today? Do they improve clinical care? We are also conducting these utility proof studies with health systems to help create a dossier of information for FDA and other regulatory submissions.
There are a lot of business partnerships we can create to combine proteomics with tests that are already out there. Proteomics combined with genetic testing, gives us a window into 90-plus percent of human disease. We’re in discussions with some companies that make genomic tests and applications to address this market.
We believe that at some point in the future we’ll have a direct-to-consumer opportunity because we have tests that can characterize or predict not only acute disease, but health and wellness measures as well. We have a test in development for sleep quality. We’re working on a cognitive function test and another for frailty. The direct-to-consumer opportunity will likely require partnerships to acquire the competencies we need to make this a reality.
What would an ideal use of the SomaLogic technology look like in preventative care?
Smythe: I’ll give you a few scenarios. One is the ability to predict someone’s likelihood of an acute event or worsening of disease in the near future in a traditional doctor-patient relationship. In this scenario, the doctor will run a battery of tests to tell what your chance of a stroke is in the next four years, or your chance of renal failure or kidney function over the next four years. These tests are also sensitive to change, so if a person makes lifestyle modifications, such as losing weight, we can repeat the test to determine how their biologic risk is changing. It’s huge to be able to track progress in real time because currently it’s really messy to try to predict these things.
I believe that telling someone their actual biologic risk of disease will have a very powerful impact in direct patient care. I was a practicing clinician for 20 years and witnessed how human beings have this incredible innate ability to sublimate risk. If I told someone they had a lung cancer so they probably need to stop smoking because the chances of having a recurrence of lung cancer are dramatically higher than baseline, the guy might say, “Well, my uncle had a lung cancer and he kept smoking and he was fine.” We all believe that we’re exceptional but we know from another context – genomic testing – that if you give someone a BRCA1 test, they usually act on that because it’s immutable data about their body.
We also think there’s a huge benefit to populations and for people who are managing populations. Let’s say we’re working with the national health service in Spain — we’re not yet but we’d love to — and we tell them we have a test that can identify which subsets of people with diabetes are at risk for a secondary complication in the next four years. One can then imagine the impact of that downstream. Let’s say it’s 2 million people that actually have diabetes in that population and we can identify for them the 20,000 at highest risk, they would focus most of their efforts and deploy resources next year for those people because they know where all the money is going to be spent. Then we can ask how many clinicians do we need? How many clinics do we need to support this?
There are plenty of companies doing this using EHR data and claims data, extracting insights indirectly from that information and some of them are pretty good. We think we’re going to blow those applications out of the water for populations because we will be telling you what the population’s risk is based on individual biological data that just hasn’t existed previously.
Now, let me just give you one more example. We also believe that over the next several years we may be able to use proteomics to directly support clinical decision making. As we continue to work with health systems, we hope to be able to say, “Okay, your risk of a heart attack or stroke in the next four years is very high and based on your protein expression pattern, and this is the treatment you should have.” We’ll be able to pinpoint, or at least hopefully narrow the treatment choices that are most likely to lower your risk instead of guessing.
What should existing and prospective clients expect in the next 18 to 24 months?
Smythe: On our life sciences side, supplying to researchers and biopharma, they’re going to see a diversification of the sorts of products and services we offer. Currently, it’s mostly giving them data back from the samples they send us on what proteins are there and in what relative amounts. We will begin providing bioinformatics services and analytics services to those customers, and we’ll be diversifying the types of measurement tools we give those investigators. In fact, we just launched disease-specific measurement and custom measurement panels in addition to our large-plex offering.
On the clinical side, we believe the developing market will see validation and utility proof studies that show how our diagnostic tests are novel, unique and impactful. We’ll be rolling out another 5 to 10 tests from our pipeline over the next 18 to 24 months as well.
There are many interesting clinical trial use cases for our diagnostic tests in pharma. An epidemic of fatty liver disease is occurring around the world, and we have a test right now that can tell you about NASH, which is Nonalcoholic Steatohepatitis. Currently to diagnose NASH, you have to do an invasive liver biopsy, but we have a test that can diagnose it with 90 percent sensitivity from a blood draw. We can also tell you if your treatment is having an effect without having to repeat the biopsy.
And in cardiovascular disease, our tests could be used to assess cardioprotective drugs for diabetics with small vessel disease. It’s really difficult to know, a few months into a trial, if anybody is getting any biologic benefit. Instead, you’re waiting to see who has an MI and who doesn’t. We could tell you in the first two or three months if this person’s health status is changing.
What advice would you offer to other CEOs and entrepreneurs?
Smythe: Everything’s contextual. The one thing I would say is that my personal philosophy is that even though everybody says “people are your most important asset,” I actually take that to another level: Companies are nothing but the people that constitute them. They are nothing else.
Focusing on people, talent and personal development cannot be underestimated and if you want people to perform over time and perform at the top of their abilities, you need to appeal to their higher order values. There is a ton of social research that says people work much longer and much harder if they believe they’re working for an ideal or a belief versus working where they’ve been threatened with some type of punishment for not performing or simply offered more money when they do. CEOs often don’t take the time and effort to think really hard about what they can do to inspire employees, make them think that what they are doing every day is really important – that it is is going to be impactful and that the work really matters. In health care that should usually be easy but it’s always shocking to me how little time some leaders spend on that.
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