BG Medicine Announces Receipt Of CE Mark For Its Galectin-3 Blood Test
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BG Medicine, Inc., a privately-held developer of biomarker-based in vitro diagnostics, announced the commercial launch in the European Union of a new, CE-marked test for the measurement of galectin-3 in human plasma or serum. Galectin-3 was first shown by researchers at the University of Maastricht, The Netherlands, to play an integral role in the development and progression of heart failure.
"This is an important point in our development of galectin-3 testing and a milestone for the company," noted Pieter Muntendam, MD, President and CEO of BG Medicine. "Heart failure is a complex and heterogeneous condition, and the objective of our BGM Galectin-3™ test is to redefine heart failure on the basis of underlying disease processes, not as it is currently addressed based solely on the nature and severity of signs or symptoms."
Galectin-3 is a protein that is involved in the biological processes leading to cardiac fibrosis and scarring, which play an important role in heart failure development and progression. Several studies have shown that galectin-3 may provide valuable insight about heart failure and its underlying disease processes.
The BGM Galectin-3 test is currently available for clinical use only in the European Union and certain other European countries as an aid in the stratification of patients diagnosed with heart failure. The BGM Galectin-3 test is not available for sale or distribution in the United States or Canada. The Company has submitted a 510(k) application to obtain clearance from the U.S. Food and Drug Administration to sell the test in the United States.
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