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Early Mass General Study Results Could Broaden Use Case for Prevencio Heart Disease Test


NEW YORK – Early results from a study conducted at Massachusetts General Hospital could help broaden the use case and commercialization prospects for Prevencio's flagship cardiovascular test, according to the firm's CEO.

At the 2023 Transcatheter Cardiovascular Therapeutics scientific meeting last month, the firm presented a study abstract on the tests results. In the meantime, a manuscript has been submitted for consideration for print in an undisclosed journal, according to Prevencio CEO Rhonda Rhyne, demonstrating the utility of using the HART CVE panel, which determines a patient's one-year risk of heart attack, stroke, or cardiac death, to risk stratify patients with chronic total occlusions for major cardiac adverse events (MACE) and cardiovascular death. 

In the study, researchers utilized samples from 1,251 patients enrolled in the multiyear Catheter Sampled Blood Archive in Cardiovascular Diseases study at Mass General at the time of receiving a coronary or peripheral angiography, with blood collected both before and after catheterization. About a quarter of the patients, 309, had chronic total occlusions (CTO) — complete or nearly complete blockages of one or more coronary arteries — but 68 had patent coronary bypass grafts and were excluded. Patient outcomes, including MACE and cardiovascular death, were tracked for an average of nearly four years. 

According to the study abstract, the high-risk group stratified by HART CVE had considerably higher incidence of MACE or cardiovascular death compared to the low-risk group, and it was 12 times more likely to experience an adverse cardiac event within four years. 

Rhyne noted that approximately 25 percent of patients with a coronary arterial obstruction have CTO. However, the risk for complications when doing interventions can be high, so lower-risk patients may not want to undergo coronary interventions such as stents, while being able to accurately risk stratify patients "could aid clinicians in making informed decisions about intensifying or personalizing medical therapy," she said.

The HART CVE blood test, one of three tests Kirkland, Washington-based Prevencio has commercialized, uses an artificial intelligence-based algorithm consisting of four protein biomarkers: NT-proBNP, which is associated with stress in the heart; Kidney Injury Molecule-1, which is related to dysfunction of kidneys and heart and with vascular inflammation; osteopontin, which is associated with calcification and plaque obstruction in the heart arteries; and TIMP-1, which is associated with risk of heart artery plaque rupture. The test has been available commercially since 2021, when the firm inked a commercialization agreement with Atlas Genomics. 

The goal of the study was to expand the test to a new patient population, and the results could allow the company to further broaden its commercialization strategy, as in the past it has focused primarily on outpatient use of the test. However, on high-risk patients, percutaneous coronary intervention is usually performed in inpatient settings, opening up new places where the test could be used.

The company has conducted additional studies to build use cases for HART CVE in other patient populations, as well. In addition to its external validation study published in Biomarkers in Medicine in 2020, which found the test's negative predictive value was 99 percent and the area under the curve was 0.86, Prevencio published a study earlier this year in the International Journal of Cardiology validating use of the test to predict cardiovascular events in patients with chronic kidney disease who underwent coronary catheterization. 

Prevencio has other ongoing studies in place for the test, including projects with Memorial Sloan Kettering Cancer Center and Emory Winship Cancer Center investigating the ability of HART CVE to provide a baseline for patients undergoing cancer treatment and its ability to accurately measure the cardiotoxic effects of chemotherapy and radiation. 

The test "can alert clinicians of increasing cardiovascular risks/changes from baseline associated with radiation and chemotherapeutic treatments which allow individualization of therapy," Rhyne said. Both Emory and Memorial Sloan Kettering are finishing manuscripts describing the results.

Mark Houston, director of the Hypertension Institute and vascular biology at St. Thomas West Hospital, said that he has used the HART CVE test for high-risk coronary heart disease patients with many risk factors, such as previous myocardial infarctions, coronary artery bypass grafts or stents, or strong family history of heart disease. The test offers "improved analysis of prevention of coronary heart disease beyond the usual standard of care," he noted. Early identification of heart disease and myocardial infarction risk is a key benefit because it can allow for early prevention and treatment, he said.

Prevencio's other main commercialized test is its HART CADhs assay, which is used to diagnose obstructive coronary artery disease and indicates whether a patient is at imminent risk of a heart attack. It is also commercializing HART KD, a test for diagnosing Kawasaki disease, which causes inflammation of the blood vessels and is usually found in children. 

Prevencio offers all three assays as laboratory-developed tests in an attempt to get market traction and commercial uptake before submitting them to the US Food and Drug Administration for regulatory approval, Rhyne said. Right now, the company is in discussions with multiple companies that have large immunoassay platforms placed in hospitals to develop the HART tests on their systems to go through the FDA process, she added.

The commercialization efforts have been assisted by the company's receipt of Medicare reimbursement starting in 2023, which has further opened the market for additional test utilization, according to Rhyne. The firm had previously been focused on cash-pay physician practices, such as concierge medicine, but it can now expand to other kinds of physicians' offices, including internists and cardiologists. Each of the tests is priced at $390.75, and Rhyne said the company is in the process of gaining coverage from private payors. 

The company has seen interest in its tests from physicians because they are cost-effective and accessible, requiring only a blood draw rather than functional tests that require an echocardiogram or coronary angiogram, she said. Although Rhyne noted that test sales and volumes are confidential, she said that the company is "pleased with the adoption rate." 

The firm is working on multiple upcoming tests, as well, including a new panel to predict whether patients will develop heart failure that would use different biomarkers than HART CVE. Prevencio aims to finalize the biomarkers included in that panel in the next quarter, with the test possibly available for patient use in 2024, Rhyne said. 

It has also developed the HART PAD test to predict obstructive peripheral artery disease, the HART AS test to screen for severe calcific aortic stenosis, and the HART AKI assay to predict acute kidney injury.