BG Medicine is a diagnostics company focused on the development and commercialization of novel cardiovascular tests. The company has two products: the BGM Galectin-3 test for use in patients with chronic heart failure, and the CardioSCORE test for the risk prediction of major cardiovascular events.
The company announced today that it has obtained a CE Mark enabling the commercial sale of its CardioSCORE test in the European Union and other countries that recognize the CE Mark. The patented diagnostic blood test is designed to dramatically improve risk prediction of significant cardiovascular events beyond the current traditional risk factor assessments such as the European SCORE and the Framingham Risk Score.
BG Medicine’s test is performed on a standard blood sample and utilizes algorithmic analysis to combine the results of seven reimbursed protein assays. It also involves a scoring system that yields a quantitative result ranging from 0.0 to 10.0, with higher values indicating the patient has an elevated risk for a major cardiovascular event over the next three years. Each one point move higher represents a 30% increase in relative risk.
The CardioSCORE test is not yet commercially available in the United States. BG Medicine is continuing in active discussions with the U.S. FDA regarding 510 (k) clearance for the test in the U.S. For additional information about BG Medicine and its innovative cardiovascular blood tests, visit www.bg-medicine.com.
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