BG Medicine Files 510(k) for AMIPredict
12/28/2011 9:10:55 AM
WALTHAM, Mass., Dec. 28, 2011 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and commercialization of novel, biomarker-based diagnostics, announced today that it has filed a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance of the company's second cardiovascular diagnostic test, AMIPredict. The filing was made following the successful completion of a validation study using data from the company's BioImage Study, which involved approximately 6,600 individuals. Results of the validation study were consistent with company's design objectives for this new test. The test aims to improve the identification of individuals at high risk for near-term major cardiovascular events, such as heart attack and stroke, over conventional risk factor scoring, such as the Framingham Risk Score. Identifying individuals at high risk for near-term cardiovascular events is the first step in being able to implement effective risk reduction strategies. AMIPredict is an in vitro diagnostic multivariate index assay that simultaneously measures multiple protein biomarkers in patients' blood and calculates a risk score.
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