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BG Medicine Files 510(k) for Automated Galectin-3 Test on Abbot Architect Platform


BG Medicine said last week that it filed a 510(k) submission with the US Food & Drug Administration for an automated version of its BGM Galectin-3 heart failure test to be run on Abbott Laboratories' Architect platform.

If it receives clearance, the new assay would be the first galectin-3 test on an automated platform and would represent a significant milestone for BG Medicine, which has maintained that moving its galectin-3 assay to an automated format is key to driving commercialization of the test.

"Subject to clearance by the FDA, the automated test would enable broader access and more timely information flow to physicians and their patients," BG Medicine CEO Eric Bouvier said in a statement.

A manual version of the test received US Food and Drug Administration clearance in 2010 and is marketed by Laboratory Corporation of America and Mayo Medical Laboratories. Automated versions of the test are being developed by Abbott, Alere, Siemens, and BioMérieux.

The company announced in May that it has obtained a CE mark and filed a 510(k) submission for an expanded use of the galectin-3 test (PM 5/17/2012). Currently the test is approved for monitoring patients with chronic heart failure. The new application would expand use to the general adult population for identification of people with an increased risk of heart failure.

According to Bouvier, this expanded indication would have a potential market of roughly 200 million people in the US and Europe, compared to around 20 million for its current use.