The European Union has granted CE mark approval to BG Medicine's diagnostic blood assay, designed to identify individuals at high-risk for near-term major cardiovascular events including heart attack and stroke.
Using algorithmic analysis, the multivariate index CardioSCORE test combines the results of seven reimbursed protein biomarkers to yield a single numerical score, ranging from 0.0 to 10.0.
Higher values indicate elevated risk for a major cardiovascular event in the subsequent three years, and each 1.0 point increment represents a 30% increase in relative risk, according to the company.
The results obtained from the test will help facilitate clinicians to provide appropriate therapy, enabling preventive intervention.
BioImage, the primary clinical validation study for the CardioSCORE, demonstrated that of 6,600 patient 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% were identified as being at high risk upon addition of their CardioSCORE result (p<0.0001).
BG Medicine president and CEO Eric Bouvier said the company believes that the test will be pivotal in the primary prevention of major cardiovascular events and treatment of disease.
"We are working aggressively to launch the test in the first half of 2013 in Europe in collaboration with specialty laboratory partners," Bouvier said.
"BG Medicine now has two products covering the continuum of heart disease diagnostics, positioning us strongly to drive the clinical usage of our important diagnostic tests for millions of patients who will benefit from them throughout the world."
BG Medicine said it is continuing its active discussions with the Food and Drug Administration for 510(k) clearance, to make the test available in the US.