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 nosology, proclaimed the commercial-grade establish in the European Union of a new, CE-marked examination for the measure of galectin-3 in thrum plasm or serum. Galectin-3 was commencement shown by researchers at the University of Maastricht, The Netherlands, to gaming an inherent character in the developing and advancement of bosom nonstarter .
“This is an authoritative gunpoint in our evolution of galectin-3 examination and a milepost for the fellowship,” celebrated Pieter Muntendam, MD, President and CEO of BG Medicine. “Heart loser is a composite and heterogenous precondition, and the object of our BGM Galectin-3™ tryout is to redefine spirit nonstarter on the footing of rudimentary disease processes, not as it is presently addressed based entirely on the nature and rigorousness of signs or symptoms.”
Galectin-3 is a protein that is byzantine in the biologic processes starring to cardiac fibrosis and scarring, which caper an authoritative purpose in nerve bankruptcy exploitation and advancement. Several studies birth shown that galectin-3 may furnish worthful perceptiveness most pump loser and its inherent disease processes.
The BGM Galectin-3 examination is presently usable for clinical use alone in the European Union and sealed over-the-counter European countries as an aid in the stratification of patients diagnosed with spirit loser. The BGM Galectin-3 trial is not usable for sale or dispersion in the United States or Canada. The Company has submitted a 510(k) covering to hold headway from the U.S. Food and Drug Administration to betray the trial in the United States.
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