WALTHAM, Mass., Dec. 11, 2012 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), a diagnostics company focused on the development and commercialization of novel cardiovascular tests, today announced that it has obtained a CE Mark enabling the commercial sale of the CardioSCORE™ test in the EU and other countries that recognize the CE Mark. The CardioSCORE test is the company's patented diagnostic blood test designed to dramatically improve risk prediction of major cardiovascular events beyond traditional risk factor assessments, such as the Framingham Risk Score and European SCORE.
The CardioSCORE test is performed on a standard blood sample and utilizes algorithmic analysis to combine the results of seven reimbursed protein assays. The test involves an independent scoring system that yields a quantitative result ranging from 0.0 to 10.0, with higher values indicating elevated risk for a major cardiovascular event in the subsequent 3 years and with each 1.0 point increment representing a 30% increase in relative risk. In the 6,600 patient BioImage Study cohort, the primary clinical validation study for the CardioSCORE test, among those who experienced a near-term major cardiovascular event during follow-up, only 26% were identified as being at high risk at baseline by traditional risk factors, whereas 54% percent were identified as being at high risk upon addition of their CardioSCORE result (p<0.0001).
"We are thrilled to bring the benefits of the CardioSCORE test to patients and physicians in Europe. We believe this test will be a pivotal and disruptive game-changer in the primary prevention of major cardiovascular events and treatment of disease, representing a major advancement over the diagnostic tools clinicians have used for the past 15 years," said Eric Bouvier, President and Chief Executive Officer of BG Medicine. "The majority of cardiovascular events occur among patients who are asymptomatic, and current risk factor assessment methods simply miss too many patients with hidden subclinical risk, delaying appropriate therapy and effective monitoring of response to such therapy. The CardioSCORE test will identify individuals at elevated risk for heart attack and stroke, enabling preventive intervention. We are working aggressively to launch the test in the first half of 2013 in Europe in collaboration with specialty laboratory partners."