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BG Medicine Seeks FDA Clearance for Second Cardiovascular Test

NEW YORK (GenomeWeb News) – BG Medicine today said it has filed with US regulators for clearance of its test for predicting near-term cardiovascular events, following the successful completion of a validation study.

The Waltham, Mass.-based firm has filed for 510(k) clearance from the US Food and Drug Administration for AMIPredict, a test for identifying individuals at high risk for near-term cardiovascular events such as a heart attack or stroke. The goal of AMIPredict is to improve upon current risk factor scoring such as the Framingham Risk Score, it said.

The test is an in vitro diagnostic multivariate index assay that measures multiple protein biomarkers in blood and then calculates a risk score. The company's FDA submission follows the completion of a validation study that used data from its BioImage Study, which included 6,600 individuals.

In a research note, Quintin Lai, an analyst at R.W. Baird, said that he believes AMIPredict is being submitted for use on Abbott's Architect automated platform. He maintained an Outperform rating on BG Medicine's stock, as well as an $11 price target.

AMIPredict is BG Medicine's second cardiovascular diagnostic test, following its galectin-3 test, which was cleared by FDA in November 2010 and is marketed by Laboratory Corporation of America.

In afternoon trading on Nasdaq, shares of the company were down 1 percent at $4.95.

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