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February 14, 2012updated 22 Nov 2018 11:19am

CardioSCORE assay could detect patients at high risk of cardiovascular events

BG Medicine has announced positive results from the pivotal validation study of its CardioSCORE diagnostic blood test, which was formerly known as AMIPredict.

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."

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