Thursday, April 11, 2013

BG Medicine, Inc. (BGMD) Receives News of CE Mark for Galectin-3 Test


BG Medicine has received news that its partner Abbott, a global leader in in vitro diagnostics, has obtained a CE Mark for the Galectin-3 assay run on the ARCHITECT immunochemistry platform.

Pending country registration, this launch of the ARCHITECT Galectin-3 test under the CE Mark will make galectin-3 testing further available in several European countries – another significant step in BG Medicine’s commercial strategy. The progress made by Abbott will expand the use of galectin-3 testing in heart failure patients and strengthen BG Medicine’s ability to drive the growth of galectin-3 testing throughout the world. BG Medicine is currently partnering with four diagnostic instrument manufacturers in order to commercialize automated versions of the BGM Galectin-3 test.

Galectin-3 is a strong indicator of prognosis and readmission risk in heart failure patients. The availability of a rapid turnaround galectin-3 result would mean heart failure patients who are at high risk of adverse events can be identified more readily. Considering the rise in heart failure, it is important for new tools to be introduced that will aid fast clinical decision making processes and supply options for exploring new interventions.

In addition to Abbott, BG Medicine is also partnering with Alere, bioMérieux SA, and Siemens Healthcare Diagnostics to provide automated versions of its galectin-3 test to key market segments. bioMérieux SA launched the test earlier this year in Europe and certain other territories that recognize the CE Mark.

Galectin-3 testing has been implicated in various biological processes that are important in the development and progression of heart failure. Elevated levels of galectin-3 are associated with a more aggressive form of heart failure – potentially making the identification of high-risk patients using galectin-3 testing an important aspect of patient care. This testing may be useful in helping physicians identify those patients who are at a higher risk of death or hospitalization, including 30-day readmission.

For more information, visit www.bg-medicine.com or www.galectin-3.com

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