NEW YORK – With a fresh $121 million in financing from its recent Series A funding round, proteomics firm Somalogic is looking to expand its SomaScan platform business and continue its push into the diagnostics space.
The Boulder, Colorado-based company is working to make assays run on its SomaScan system more streamlined and cost-efficient and more easily deployable in sites like hospital labs while also continue to expand the menu of proteins the platform is able to measure, said CEO Roy Smythe.
Smythe noted that the company has also shifted back to accepting fee-for-service work after having decided in 2017 that it would only offer access to its platform as part of research collaborations in which it retained use of the data generated through the collaboration.
At the time, Smythe said, the company believed this was necessary to collect the kind of data it needed to develop diagnostics based on its technology. More recently, though, it came to the conclusion that this approach was both cutting it off from potential business and no longer necessary given relationships it had established with biobanks and other sources of clinical samples, he said.
"We had locked ourselves out of a lot of the pharma market by mandating that they share data in a collaborative fashion in every agreement," he said. "And we now have a lot of biobank relationships around the world, and we are working on more of those, and we do think that even if we tell our pharma customers that they don't have to share clinical data with us every time, we will still get clinical data for studies we are interested in 40 percent or 50 percent of the time."
Smythe added that Somalogic is also beginning to collaborate with health systems on co-development of clinical products, which he said gives the company another source of clinical data.
At the same time, the company continues development and commercialization of its SomaSignal tests. The SomaScan platform uses the company's aptamer-based affinity reagents called Somamers to measure proteins in patient samples, typically blood. The platform currently measures 7,000 proteins per sample (recently expanded from around 5,000), and SomaLogic believes that measuring this large number of proteins across large numbers of samples will provide it with the data it needs to identify correlations between protein measurements and patient health that it can package as diagnostics.
The company launched its first SomaSignal tests last year, offering them at several Colorado doctors' practices. The assays test for risk of major cardiovascular events in patients with and without known heart disease; whether patients show the effects of heavy drinking; patient aerobic fitness levels; the presence of excess liver fat; and percent body fat and lean tissue.
Smythe said the rollout of these tests at the local practices had been slowed by the SARS-CoV-2 pandemic, but that the company had sold roughly 1,500 tests into those practices since the launch.
He added that the company has since developed another 10 tests focusing primarily on management of chronic diseases.
Smythe said that in addition to piloting the tests with the Colorado practices, Somalogic has also been making them available to pharma firms as research tools. He cited the example of the company's test for non-alcoholic steatohepatitis (NASH), which he said can determine whether or not a patient has NASH and what histologic subtype a patient has. The company launched the test roughly two months ago and has signed one pharma customer to use it in a clinical trial.
Nelson Trujillo is a cardiologist with Boulder Community Health and one of the physicians using the SomaSignal tests as part of the company's initial roll-out. Trujillo, who has no financial stake in Somalogic, said that he primarily uses the company's Secondary Cardiovascular Risk test, which provides a patient's risk of having a cardiovascular event within four years of a prior cardiovascular event.
Trujillo said he has used the test in around 300 patients so far, with around 250 of those patients being followed as part of a clinical trial he is conducting with Somalogic on the utility of the test.
He said that he finds the test useful for identifying patients at high risk of another event whose risk is not captured by conventional measures like cholesterol or tobacco or alcohol use.
"We all know people who do everything right and still have an event, and we all know people who do everything wrong and still live to be 100," Trujillo said. "So, is there a way to start to tease that out?"
He acknowledged that the trial being done in his practice is a small one, but noted that some findings indicate the test is providing information beyond what is provided by traditional risk measures. For instance, he said that some of the individuals at highest risk of an event based on their SomaSignal score had normal cholesterol levels. Additionally, he said that he had found patients' scores improved in response to interventions.
"What we've learned in our little trial is that we look at isolated pieces of people — their cholesterol, their smoking history, their family history, and that isn't necessarily sufficient to find the people at the highest risk," he said.
Trujillo said that the SomaSignal test results have changed his clinical decisions in that he will suggest a more aggressive course of treatment for a patient with a high-risk score even if all of that patient's traditional risk measures are low or normal.
"If someone comes in and says, I'm 37, my calcium score is 2, my LDL cholesterol is 100, I'm a triathlete, and I don't want to take medicine, but their SomaSignal comes back and their risk [of an event] is 40 percent over five years, I say, that's all true, but your body's interaction with your environment suggests that your risk is a lot higher, and we need to be aggressive," he said.
As a cardiologist seeing patients with established cardiovascular disease, undertreatment is perhaps a bigger concern for Trujillo than overtreatment.
"Where I worry [about the test] is the negative side," he said. For example, if he has a patient who's had a heart attack or stent, and after a year has passed, he receives a SomaSignal result saying his risk of a cardiac event is low, and he doesn't want to be on meds any longer, "How comfortable am I saying, your risk is low, you're right, you don't need to [take any medicine] even though guidelines would say you need this, that, and the other?"
"When we start to change treatment in the negative in response to SomaSignal, there I'm gun-shy, still," he said. "I believe the science. But I'm not 100 percent in belief."
Trujillo's hesitance is due substantially to the fact that, while he believes the test is useful for identifying at-risk patients missed by traditional measures, the performance of the assay hasn't been rigorously judged against real "gold standard," he said.
"There hasn't yet, and I don't think there will ever be, a blind trial where you take 100,000 people and you do their SomaSignal, and then you don't do anything to them for 10 years, and you find out what happens to them," he said.
In cases where traditional risk measures and the SomaSignal score conflict, caution might dictate that a doctor treat the patient as high risk, but, as Trujillo noted, no large clinical trials have demonstrated which measure is likely the correct one in such situations.
Trujillo said that another issue that could make the SomaSignal test a tough sell to many doctors is the ambiguity around what, exactly, the assays are measuring. A number of clinical researchers have voiced concerns about the SomaScan platform's specificity and how well-validated the individual assays are. For instance, as part of the UK's Interval study, researchers used the platform to quantify plasma protein levels of 3,301 apparently healthy, genotyped subjects, with 14 percent of the Somamers showed non-specific binding, either to a protein other than the target protein (7 percent) or to a protein isoform (7 percent).
Somalogic acknowledges that it has not thoroughly characterized the target and off-target binding for each of its Somamer reagents, but the company believes its strategy of making measurements in large cohorts and observing reproducible signals that they can train against specific endpoints will allow it to develop clinically useful assays.
Trujillo noted that while he believes this is a valid approach, it's one to which many of his fellow doctors are less accustomed.
"They're not comfortable with it at all," he said. "The real hard part from the doctor point of view is, when we get the SomaSignal result … it lists the proteins, and most people want to know what the proteins are and what they do and how to change them. And that's not how the test works. These are just signals. And that has been an Achilles heel to some degree."
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