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Automated VIDAS(R) Galectin-3 Assay Validated In Published Clinical Research Study

Stocks in this article: BGMD

WALTHAM, Mass., Jan. 28, 2014 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3 ® Test, welcomed today the publication of results of a clinical research study that demonstrate and validate the analytical and clinical performance of the automated VIDAS ® Galectin-3 assay that was developed by bioMérieux SA, a world leader in the field of in vitro diagnostics and one of BG Medicine's automation partners.

In this clinical research study, published online ahead of print in the journal Clinica Chimica Acta, elevated galectin-3 levels in previously collected blood samples, measured using the VIDAS ® Galectin-3 assay, were reported to be significantly predictive of fatal cardiovascular events and severity of heart failure among the 137 patients diagnosed with chronic heart failure who were tested.[1] The prognostic information provided by the VIDAS ® Galectin-3 assay in this published clinical research study was found to be complementary and additive to that obtained by measurement of three different types of natriuretic peptides, including BNP, NT-proBNP and proBNP. The significant predictive value of galectin-3 levels was further demonstrated to be independent of other key clinical parameters, such as impaired kidney function, reduced cardiac left ventricular pumping capacity, and age. When evaluated for analytical performance, measurement values obtained with the VIDAS ® Galectin-3 assay were found to be in excellent agreement with those obtained with the BGM Galectin-3 ® Test.

 "We are very pleased with the results obtained with the automated VIDAS ® Galectin-3 assay in this clinical research study," said Dr. Paul R. Sohmer, President and CEO of BG Medicine, Inc. "These results support commercialization of the VIDAS ® Galectin-3 assay in Europe and substantiate our efforts to assist bioMérieux with its pursuit of 510(k) clearance of the assay in the U.S."

The VIDAS ® Galectin-3 assay was developed by bioMérieux for the quantitative measurement of galectin-3 levels in blood using the bioMérieux VIDAS automated and multiparametric immunoassay testing system. The VIDAS ® Galectin-3 assay requires 200 microliters of blood plasma or serum and is designed to return test results within 20 minutes. [2] This automated and quantitative assay for galectin-3 in blood is CE Marked and currently available in Europe as an aid in assessing the prognosis of patients diagnosed with chronic heart failure when used in conjunction with clinical evaluation.

[1] Gruson D, Mancini M, Ahn SA, Rousseau MF. Galectin-3 testing: Validity of a novel automated assay in heart failure patients with reduced ejection fraction, Clin Chim Acta (2013), http://dx.doi.org/10.1016/j.cca.2013.12.017.

[2] bioMérieux SA. (2014). VIDAS® Galectin-3. Retrieved from http://www.biomerieux-diagnostics.com/servlet/srt/bio/clinical-diagnostics/dynPage?open=CNL_CLN_PRD&doc=CNL_CLN_PRD_G_PRD_CLN_99&pubparams.sform=0&lang=en.

About Galectin-3 and Heart Failure

Galectin-3 has been implicated in a variety of biological processes important in the development and progression of heart failure. Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care. Galectin-3 testing may be useful in helping physicians determine which patients are at higher risk of death or hospitalization, including 30-day hospital readmission.

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