Biomarker Shows Promise For Improving Patient Outcomes and Reducing Costs
NEW YORK — Critical Diagnostics today announced publication of a key opinion article describing the utility of the cardiac biomarker ST2 for assessing cardiac risk in the emergency department. The article, published in the College of American Pathologists journal CAP Today is titled “ST2 in the ED: Will it nail cardiac risk.” The article summarizes the opinion and experience of an international group of key thought leaders in the utilization of biomarkers in the application of emergency medicine and cardiology. The consensus is that, although still at an early stage of development, the ST2 assay shows great promise as a valuable tool in treating patients who are diagnosed with cardiovascular disease or who present with symptoms of cardiovascular disease.
Contributing to the article were Robert H. Christenson, Ph.D. (Director of Core Laboratories at the University of Maryland Medical Center and Professor of Pathology and of Medical Research and Technology, University of Maryland School of Medicine), James L. Januzzi, MD (Associate Professor of Medicine at Harvard University, and Clinical Director of the Cardiac Intensive Care Unit at Massachusetts General Hospital), Robert L. Jesse, MD, Ph.D. (Director of Acute Cardiac Care for Virginia Commonwealth University Health System, Chairman of the Cardiology Division at the Veteran Affairs Medical Center in Richmond, and National Program Director for Cardiology for the Veterans Health Administration in Washington, DC), Jordi Ordonez-Llanos, MD, Ph.D. (Professor of Clinical Biochemistry at Hospital Santa Creu I Sant Paul in Barcelona), W. Frank Peacock, MD (Vice Chief of Emergency Medicine at the Cleveland Clinic), and Richard L. Summers, MD (Professor of Emergency Medicine at the University of Mississippi Medical Center, Oxford).
“Researchers around the world have recognized the importance of this (ST2) marker in each study, and the consistency of results is really remarkable,” says Dr. Januzzi. Speaking of the evolution in cardiac markers, Dr. Christenson comments, “Everybody in this field is searching for that Holy Grail, a marker that will not only predict risk but also may be key to treatment… Then ST2 comes along and, consistently in trials for not only heart failure but also for acute coronary syndrome, it’s a better predictor of death… This is a marker that people will actually see become useful in laboratories in the next few years.” Dr. Peacock echoes some of the same sentiments. “ST2 could also work on acute coronary syndrome as well as heart failure,” adding, “...it’s a ‘this-dude-is-sick’ marker that’s extremely valuable in the emergency department.”
“It’s very consistent,” says Dr. Christenson, “If you come into the ER with shortness of breathe, and you have a value of ST2 greater than 0.2ng/ml, then you’re a high-risk patient.” According to the article’s author, Anne Paxton, “Christenson believes ST2 may be an even broader marker than BNP or NT-proBNP.” “While we think naturetic peptides are very useful, they are not perfect,” says Dr. Januzzi, adding, “…to have another cardiac biomarker with profound value to assist naturetic peptides testing in evaluating the acutely dyspneic patient – with or without heart failure – would be welcome. We may have found it.” “What ST2 adds is a much sharper risk assessment,” according to Dr. Peacock. “BNP won’t identify all the people who do worse. ST2 identifies more, so it’s a better prognostic tool. It’s a great discriminator.”
In addition to the previously published results describing the utility of ST2 in assessing the risk of mortality in patients presenting with symptoms of heart failure recent research results extend this to include patient monitoring. Alan Maisel, MD and Rob Fitzgerald, Ph.D. at the University of California, San Diego, have reported results from a cohort of patients hospitalized for acute decompensated heart failure showing that ST2 is a stronger prognostic indicator than natriuretic peptides. The conclusion from this study is that those patients whose ST2 levels remained high during treatment had a higher likelihood of mortality, irrespective of their BNP levels. In fact, among those patients destined to die, BNP levels often trended downward, while the ST2 concentrations did not. “So the take-home message – since we’re lately focusing on BNP as a tool to identify those patients not responding to medical therapy – is that ST2 may be superior for this indication,” according to Dr. Januzzi. Expanding on the description of the utility that ST2 shows for patient monitoring Dr. Ordonez, describes results from analysis of an ADHF outpatient cohort. Dr. Ordonez comments, “ST2 was predictive of events in this population with long-term followup, even stronger than NT-proBNP.”
“Effectively managing and treating patients presenting with symptoms of cardiovascular disease is particularly challenging for emergency department physicians with the tools available to them today. And it doesn’t get any easier after admission or during outpatient monitoring. Our research results, as described by these key thought leaders and published in major journals, indicate that ST2 is a novel cardiac biomarker that, in these applications, is superior to the existing gold standard biomarkers for cardiovascular disease, troponin and natriuretic peptides. As a cardiovascular risk stratification and disease severity determination biomarker ST2 has the potential to significantly improve the delivery of patient care and lower overall cost,” comments Critical Diagnostics President James V. Snider, Ph.D., adding, “The body of evidence supporting the clinical value of ST2 is growing as several additional research studies have been completed with results being prepared for publication and new studies are being initiated.”
The complete CAP Today article is available online at www.cap.org or can be downloaded from the company website at www.criticaldiagnostics.com.
About Critical Diagnostics
Critical Diagnostics is the exclusive developer of the Presage™ laboratory assays employing ST2 for the diagnosis and prognosis of cardiovascular disease.1 Critical Diagnostics was founded in 2004 and is funded by Carrot Capital Healthcare Ventures (CCHV) of New York. CCHV focuses on promising seed- and early-stage investment opportunities across a broad spectrum of the healthcare industry.
1Presage and assays employing ST2 are not currently approved by the FDA for clinical use and are not available for sale in the US for clinical use.
Contacts
Critical Diagnostics
James Snider, President, 925-399-5035
jsnider@criticaldiagnostics.com