BG Medicine Announces 510(k) Filing for the ARCHITECT Galectin-3 Assay on the Abbott Laboratories ARCHITECT Automated Platform
Published: Jul 20, 2012
WALTHAM, Mass, July 20, 2012 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), a company focused on the development and commercialization of novel cardiovascular diagnostics, today announced the filing of a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay, which is used with Abbott's fully automated ARCHITECT immunochemistry instrument platform. The test measures a patient's blood level of galectin-3, a protein implicated in the progression of heart failure. Subject to FDA clearance, the new application would mark the first measurement of galectin-3 on an automated platform.