BG Medicine, Inc. Files 510(k) for a diagnostic test to predict heart attacks - Gilde Healthcare

BG Medicine, Inc. Files 510(k) for a diagnostic test to predict heart attacks

28 december 2011

WALTHAM, Mass., – 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.
 
BG Medicine intends to disseminate the results of the study and discuss the market opportunity for the product via a conference call and webcast by early February.
 
About BG Medicine, Inc.

BG Medicine, Inc. (Nasdaq:BGMD) is a life sciences company focused on the discovery, development, and commercialization of novel, biomarker-based diagnostics to improve patient outcomes and contain healthcare costs. The company markets the BGM Galectin-3TM test for use in patients with heart failure. BG Medicine also has products in development to aid in the diagnosis and management of acute atherothrombosis and lipid disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.bg-medicine.com and www.galectin-3.com.

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