Cardiovascular Disease Risk Scores Could Help Physicians Better Manage Patient Outcomes

An upcoming randomized, controlled study enrolling 248 physicians is measuring whether SomaLogic’s SomaSignal tests help doctors with cardiovascular disease risk stratification for their patients.

Researchers from the University of California San Francisco (UCSF) are hoping to determine whether these physicians are more likely to prescribe high-risk patients with drugs to help control blood glucose (SGLT2 inhibitors and GLP-1 receptor agonists) in better alignment with current medical guidelines.
 
“Through prior research we discovered that physicians using traditional risk factors are having difficulties in calculating and applying risk scores in patient management,” SomaLogic Chief Medical Officer, Stephen Williams, M.D., Ph.D., said. “We conducted this new study to see if we can show that individualized proteomic cardiovascular risk assessment could play a positive role in this scenario, enabling more effective allocation of drugs and improving patient outcomes.”
 
The study, conducted by QURE Healthcare, measures the use of SomaSignal test results in clinical practice using scientifically validated patient simulations to uncover what clinical decisions practicing physicians are making with patients. The full study is expected to be published in an upcoming peer-reviewed journal.
 
“We conducted this independent randomized trial to determine the causal impact of a more personalized risk-stratification tool,” said John Peabody, M.D., Ph.D., a professor of epidemiology and biostatistics at UCSF and the study’s principal investigator. “A positive study provides clinicians with a better tool—and one they are more likely to use—when caring for their patients.”
 
SomaLogic’s CardioDM test, a version of the SomaSignal cardiovascular test, is currently being used in clinically focused partnerships with healthcare providers as part of the SomaSignal Proteomics for Precision Medicine Initiative. As part of the program, launched in 2021, disease-focused randomized clinical trials are being conducted by several U.S.-based healthcare innovators in diverse therapeutic areas, including Type 2 diabetes and cardiovascular disease.
 
Trials were launched with initial partners: Emory University, CommonSpirit Health and UCHealth. During these trials, healthcare providers are evaluating CardioDM in their clinical practices by assessing current health state and disease risk based on a patient’s proteomic signature and determining whether to change treatment because of the new information these tests provide. Clinicians are also evaluating whether providing these uniquely personalized test results to their patients motivates them to be more adherent to care recommendations.
 
Additionally, SomaLogic recently provided a data pre-submission for this test to the U.S. Food and Drug Administration (FDA). CardioDM is based on 27 different protein biomarkers which can predict the four-year risk of a cardiovascular event with the median time-to-event of about 20 months.

“SomaSignal tests continue to improve our understanding of an individual’s unique cardiac risk. More importantly, it can guide patients’ and providers’ choices regarding both lifestyle and pharmacological interventions to reduce that risk,” said Nelson Trujillo, M.D., a board-certified cardiologist who is an investigator on the study. “As a long-time user of this test in my own clinical practice, I concur with the findings of this study on this large group of physicians. I have seen it impact my own treatment recommendations and it represents a clear move forward in medical practice.”
 
SomaSignal tests are developed, and their performance characteristics determined, by SomaLogic. They have neither been cleared or approved by the FDA. SomaLogic operates a Clinical Laboratory Improvement Amendments (CLIA) certified, and College of American Pathologists (CAP) accredited laboratory.