FirstMark's Landmark Clinical Study Successfully Completed that Fulfills the Unmet Need to Access the Risk of Near Term MI
SAN DIEGO, Feb. 16, 2012 /PRNewswire-iReach/ -- FirstMark today announced the completion of the clinical study for the multiple biomarker cardiovascular blood test PREvent. These clinical results demonstrate the extraordinary effectiveness of the test to predict near term (2-3 years) risk of myocardial infarction and death in patients with suspected or confirmed, insignificant or significant CAD. The clinical study and final data was well received in an oral presentation, An Aggregate of 3 Biomarkers Predict Very High Risk of Acute Myocardial Infarction and Death, by Dr. Stephen E. Epstein, Executive Director of the Cardiovascular Research Institute, MedStar Health Research Institute, at the Cardiovascular Research Technologies 2012 Conference in Washington D.C. on February 6, 2012.
The study revealed superior cardiac risk information by identifying the top 5% of CAD at the highest risk of MI with a hazard ratio of 5.5. The data showed an annual average of 18.2% of significant CAD patients with all three biomarkers elevated experienced a myocardial infarction or death, compared to only 2.45% of significant CAD patients with all biomarkers normal. The multiple biomarker model adds markedly to traditional risk-prediction by significantly improving C-statistics from 0.695 for base model to 0.750, distinguishing high risk from low risk subjects.
"We are very pleased about the outstanding data results, and the promise PREvent brings to cardiovascular medicine," said Thomas Silberg, President and CEO of GenWay Biotech. "It's important for physicians to have a simple method to detect patients at greatest risk of near term MI. Ideally this information will lead to the most aggressive therapy, compliance and management in hope to eliminate MI and reduce death."
About the Study
The study was based on long-term research that reveals that there are multiple factors involving components of inflammatory, thrombotic, infectious, and autoimmune pathways that contribute to the development of CAD, subsequent plaque rupture, and adverse outcomes. The research interrogated these pathways both separately and combined, utilizing HSP70, HSP60, hsCRP, FDP levels and seropositivity to CMV biomarkers. The biomarker panel was narrowed down to three markers that provide most valuable information to include hsCRP, FDP, and HSP70. A bioanalytic statistical ranking model (the Aggregate Pathway Risk) was developed that best predicts existing CAD as well as imminent MI.
The controlled study included blood samples from 3,800 patients admitted for cardiac catheterization. The individuals were documented from angiograms for the presence and severity of coronary artery disease. The study design included four groups of patients angiographically confirmed with insignificant or significant CAD, with MI or death and without MI or death. Each group was followed for a minimum of 1 year and a mean of 2.75 years. Groups were matched for age, gender, and cardiovascular risk factors using propensity scoring.
Additional study details are provided at: firstmarkprevent.com
FirstMark is a division of GenWay Biotech, Inc. The FirstMark division is focused on the development and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs. Headquarters are located in the heart of San Diego's biotech community in the Sorrento Valley/Mesa area. For additional information please visit FirstMarkPREvent.com.
Media Contact: Deborah Moore GenWay Biotech, Inc., 858-458-0866 x 113, [email protected]
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SOURCE GenWay Biotech, Inc.