BG Medicine has obtained CE mark approval for its diagnostic blood assay, CardioSCORE, designed for identifying individuals who are at high risk for near-term major cardiovascular events including heart attack and stroke.
The multivariate index test uses algorithmic analysis to combine 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 3 years and with each 1.0 point increment represents a 30% increase in relative risk, claims 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 chief executive officer Eric Bouvier said the company believes that the test will be a 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 added.
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.