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Abbott Receives EU CE Mark for Automated Version of BG Medicine's Galectin-3 Test

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Abbott this week received an EU CE mark for its automated version of BG Medicine's Galectin-3 protein biomarker assay.

The assay, which is intended as an aid in determining the prognosis of heart failure patients, will run on Abbott's ARCHITECT immunochemistry platform.

BG received a CE Mark and US Food & Drug Administration 510(k) approval for a manual version of the Galectin-3 test in 2010 and has since worked with Abbott, Alere, Siemens, and BioMérieux on automated versions of the test.

Earlier this year, BioMérieux obtained CE approval for its automated version of the test.

"The launch of the ARCHITECT Galectin-3 test under CE Mark is another important step in our commercial strategy," Eric Bouvier, BG's president and CEO said in a statement. "The announcement will strengthen our ability to drive the growth of galectin-3 testing throughout the world."

Currently, the test is approved in the US for monitoring patients with chronic heart failure and in the EU for monitoring of chronic patients and identification of increased heart failure risk within the general adult population.

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