CardioSCORE, a diagnostic blood test designed to improve risk prediction of major cardiovascular events beyond traditional risk factor assessments, has received CE Mark approval in Europe.
The CardioSCORE test is performed on a standard blood sample and uses algorithmic analysis to combine the results of seven protein assays, according to Waltham, Mass.-based BG Medicine, a company that develops and commercializes cardiovascular tests. CardioSCORE provides an independent scoring system that yields a quantitative result ranging from 0 to 10, with higher values indicating elevated risk for a major cardiovascular event in the subsequent three years and with each one-point increment representing a 30 percent 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, 26 percent were identified as being at high risk at baseline by traditional risk factors, while 54 percent were identified as being at high risk with the addition of a CardioSCORE result.
The CardioSCORE test is not yet available commercially in the U.S. BG Medicine said it is discussing 510(k) clearance with the FDA.