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SomaLogic Using Health System Partnerships to Prove Clinical Utility of SomaSignal Tests


NEW YORK – With the launch of a recent effort to partner with healthcare providers to evaluate the usefulness of its SomaSignal tests, proteomics firm SomaLogic continues its push to drive its SomaScan platform to the clinic.

The company last week announced its SomaSignal Proteomics for Precision Medicine Initiative, through which it is planning clinical trials in areas including type 2 diabetes, cardiovascular disease, and cancer with Emory University, Intermountain Healthcare, CommonSpirit Health and UCHealth, a network of 12 hospitals and hundreds of physicians across Colorado, southern Wyoming, and western Nebraska.

The goal of the initiative is to explore within the different health systems if and how the SomaSignal tests can improve patient outcomes and the delivery of care, said SomaLogic CEO Roy Smythe. He added that the company would also look to extrapolate the studies' findings to assess the tests' health economic benefits and to get input from its partners as to what additional tests might have utility in their systems.

Smythe said that the company and its clinical partners aim to study the tests in patient cohorts on the order of hundreds, with some studies potentially reaching into the thousands of patients.

SomaLogic announced in March that it planned to go public in Q3 of this year via a merger with CM Life Sciences II, a special purpose acquisition company sponsored by affiliates of Casdin Capital and Corvex Management, and noted that it planned to put proceeds from the transaction to, among other things, pursuing additional health system partnerships.

The SomaSignal tests use SomaLogic's aptamer-based affinity reagents called Somamers to measure proteins in patient samples. The company's SomaScan platform, which it uses to develop and run the SomaSignal tests, currently measures 7,000 protein targets. SomaLogic runs the full SomaScan panel on each patient sample and then extracts the data it needs for a particular test, though Smythe said that in the future the company could move to a more targeted approach.

The company launched its first SomaSignal tests in 2019, offering them at several Colorado doctors' practices. It currently offers 12 tests as laboratory-developed tests for indications including risk of major cardiovascular events in patients with and without known heart disease, and the presence of excess liver fat.

Clay Smith, medical director of the UCHealth Innovations Center, said that while his center has not finalized its role within the SomaLogic initiative, he anticipates that it will look at SomaSignal tests for managing diabetes and chemotherapy-related cardiac disease.

Smith said that the first step in the process will likely be just "getting [the tests] into the hands of our clinical trials group and our clinical trials specialists in each of those disease areas so that they can become familiar with the tests and work out the logistics in terms of collecting specimens and getting the test results back."

He said that UCHealth would then likely try to investigate in a prospective fashion whether the tests can help guide the use of existing tests that doctors might prefer to use in a limited way due to their expense or invasiveness.

"An example might be, if someone has a high-risk cardiac score with the SomaSignal test, should we order a cardiac MRI to look more deeply for cardiovascular disease," he said, though he added that "none of this is written in stone yet."

Smith said that he expected that the initial evaluation of the SomaSignal tests and where they might fit into practice at UCHealth would take between six months and a year with those studies likely looking at several hundred patients each.

In addition to serving as medical director for the system's Innovations Center, Smith also directs its blood cancer program, and he noted that he has a strong interest "in developing oncology tests looking at early recurrence and other elements of cancer care."

He said he is enthusiastic about "the idea of proteomics as a precision medicine tool," as it could provide a much more dynamic look at patient health than the genomic-based methods that currently dominate oncology.

"I think the data that [SomaLogic] has presented to date is really compelling," he said, adding that he believed this "provides a wonderfully promising foundation."

Smith said, though, that additional data supporting the test's performance was still needed.

"We should be doing thoughtful and careful clinical trials and validating these things prospectively, ideally and ultimately in multiple institutional settings with large cohorts of people and really learning where they can be applied and where we may want to be a bit careful as we go forward," he said.

To date, use of the SomaSignal tests have largely been confined to small pilot efforts in local Colorado doctors' practices. In an interview last year with 360Dx, Nelson Trujillo, a cardiologist with Boulder Community Health and one of the physicians using the SomaSignal tests as part of the company's initial rollout, similarly noted the need for more clinical trial data supporting use of the tests.

Trujillo primarily uses the company's Secondary Cardiovascular Risk test, which assesses a patient's risk of having a cardiovascular event within four years of a prior cardiovascular event. He noted that he has changed patient management to more aggressive courses of treatment in response to SomaSignal test results but that he remained hesitant to move to less aggressive treatment based on the test.

"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. 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."

Smythe said that the company had developed and evaluated its tests in large numbers of "disparate, retrospective sample sets," noting that this gave it confidence in their performance. He said, though, that the Precision Medicine Initiative would give the company an opportunity to collect some prospective data on its tests that could prove helpful in demonstrating the tests' performance, both to potential users and the US Food and Drug Administration.

"We'll be able to glean from these studies data that supports in a prospective way our large retrospective trials … and use it to our benefit, if possible, with the FDA," he said.

Smythe said that SomaLogic would adopt different regulatory and reimbursement approaches for different SomaSignal tests. Already, the company has launched 12 tests in at least a limited fashion and has in the past discussed developing 100 or more different tests on the SomaScan platform.

"To take 100 diagnostic tests through the FDA and third-party reimbursement process would be fairly expensive and time-consuming," he said, noting that it would likely offer some tests as LDTs, while others would be paid for outside of the traditional third-party reimbursement system, potentially, for instance, by health systems themselves as part of an overall effort to lower the cost of patient care.

He cited as an example of the latter kind of test, an assay the company is currently developing to assess the risk of complications in patients with diabetes.

"If you've got 100,000 diabetics in your system and you run this test on them every couple of years, and you see that there are 5,000 patients that are actually at significant short-term risk for complications from diabetes … you can imagine the utility of that test [to a health system]," Smythe noted.

That said, "we do believe we will have to take some subset of our tests through the full [regulatory and reimbursement] process, and we are prepared to do that," he added.