BG Medicine, a developer of biomarker-based diagnostics, has reported positive BioImage validation study results of its CardioSCORE diagnostic test.
CardioSCORE is a multivariate index assay which is designed to measure the levels of seven protein biomarkers in blood and integrates the results to yield a single numerical score that is related to an individual’s near-term cardiovascular risk.
The observational; pivotal study, which enrolled 6,600 individuals, was designed to assess the ability of biological markers to improve the accuracy of baseline risk assessment for myocardial infarction (heart attack), stroke, and other major cardiovascular events, over currently used risk assessment methodologies.
The results showed that CardioSCORE testing at baseline significantly predicted high risk of major cardiovascular events in both men and women during the study’s median 2.5-year follow-up period.
In the study, of all subjects who experienced a major cardiovascular event within one year, only 28% were identified as high risk at baseline using a cardiovascular risk assessment algorithm, the Framingham Risk Score.
Similarly, of all individuals in the BioImage Study who experienced a major cardiovascular event within two years, CardioSCORE testing increased the percentage who would have been identified as high risk at baseline from 26% with Framingham risk assessment alone to 54% with the addition of CardioSCORE (P<0.0001).
BG Medicine president and CEO Eric Bouvier said they are encouraged by the positive results of this large, US-based study in which CardioSCORE combined with traditional risk factor assessment more than doubled the sensitivity for detecting near-term risk.
The company filed a 510(k) premarket notification for CardioSCORE with the US Food and Drug Administration in December 2011.