BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA.
The blood test is at present indicated for use in patients with chronic heart failure who are at increased risk for hospitalizations or death based on elevated levels of galectin-3.
Upon the FDA clearance, the new application would expand the use to the general adult population to identify those with an increased level of galectin-3, which is associated with an increased risk for new-onset heart failure.
BG Medicine executive vice president and chief medical officer Pieter Muntendam said the new indication addresses the importance of galectin-3 in heart failure development.
"The two indications combined span the galectin-3 mediated disease process from subclinical disease in those who seem otherwise healthy to those who suffer from advanced heart failure disease with high mortality," Muntendam added.
The company has also attained CE Mark for the expanded indication for the BGM Galectin-3 test and is working with its partners to start commercialization for the expanded indication in the EU.
