BG Medicine, Inc. announced that on December 29, 2014, the U.S. Food and Drug Administration made publicly available the 510(k) clearance for premarket notification number K140436, which represents the first automated version of galectin-3 testing to receive regulatory clearance in the United States. BG Medicine, Inc. is the developer of the BGM Galectin-3 Test, which is the FDA-cleared manual microtiter plate version of the galectin-3 test, and the licensor of this first automated galectin-3 assay, which is used with the Abbott ARCHITECT fully-automated immunoassay analyzer. The new assay will be commercialized through an agreement between BG Medicine and Abbott Laboratories.

As cleared by the FDA, galectin-3 testing may be used by doctors in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.