BG Medicine has announced positive results from the pivotal validation study of its CardioSCORE diagnostic blood test, which was formerly known as AMIPredict.
CardioSCORE is a proprietary in vitro diagnostic multivariate index assay that measures the levels of seven protein biomarkers in blood, and combines the results to generate a single numerical score related to an individual’s near-term cardiovascular risk.
CardioSCORE is designed to identify individuals at high risk of near-term major cardiovascular events, including heart attack and stroke.
The BioImage validation study comprised a community-based cohort of 6,600 adults recruited from Illinois and Florida, with no prior history of cardiovascular disease.
During the study’s median 2.5-year follow-up period, CardioSCORE testing at baseline considerably predicted high risk of major cardiovascular events in both men and women.
Of all subjects who experienced a major cardiovascular event within one year, the widely-used cardiovascular risk assessment algorithm Framingham Risk Score identified only 28% of subjects at high risk of cardiovascular event, compared to 60% with the addition of CardioSCORE testing.
Of all study participants who experienced a major cardiovascular event within two years, CardioSCORE testing increased the percentage of individuals identified as high risk at baseline from 26% with Framingham risk assessment alone to 54% with the addition of CardioSCORE.
BG Medicine president and CEO Eric Bouvier said, "CardioSCORE is an easy-to-use blood test designed to identify adults at near-term risk of heart attack or stroke before their first cardiovascular event."
"We are extremely encouraged by the positive results of this large, US-based study of 6,600 subjects, in which CardioSCORE combined with traditional risk factor assessment more than doubled the sensitivity for detecting near-term risk," Bouvier added.
The BioImage study is an ongoing study implemented through the HRP (High Risk Plaque) Initiative, a $30m consortium, and Humana, a health benefit provider.
BG Medicine chief medical officer and executive vice president Pieter Muntendam said, "BG Medicine was the first to partner with a health benefit provider to establish a cohort such as the BioImage study, and is proud to be working with Humana and our academic and industry partners towards the important goal of preventing heart attack and stroke."