BG Medicine‘s 96-well microtiter plate-based ELISA for Galectin-3, a biomarker that’s correlated with prognosis in patients with chronic heart failure now has the FDA’s stamp of approval. Galectin-3 is a protein that binds and activates myofibroblasts in damaged heart tissue, which leads to collagen synthesis and subsequently problematic fibrosis.
Though the current use case for galectin-3 is simply to get a better sense for the probability of adverse disease outcomes in patients with heart failure, ideally, treatments would be found that work best in patients with high galectin-3 levels. Believers include Abbott, Alere, and bioMérieux, who have all entered agreements with BG Medicine to commercialize the assay for use in their own systems.
From the press release:
Galectin-3 is a protein that has been shown to play an important role in the development and progression of heart failure in approximately 30% of the patients diagnosed with heart failure.i This galectin-3 mediated form of heart failure is associated with progressive fibrosis, or stiffening, in the heart muscle, which impairs the heart’s ability to pump.ii The role of galectin-3 in heart failure was first established in 2004iii, and the clearance of the company’s Galectin-3 blood test now for the first time allows physicians to use this product in the evaluation of patients diagnosed with heart failure.
“The availability of a galectin-3 test to identify high risk patients with cardiovascular disease and myocardial fibrosis represents another step toward the goal of enabling more efficient targeting of therapeutic approaches to reduce fibrosis in patients with chronic heart failure,” said Bertram Pitt, M.D., F.A.C.C., professor of internal medicine, Division of Cardiology, University of Michigan School of Medicine.
Product page: Galectin-3 …
Press release: BG Medicine Announces FDA 510(k) Clearance of its Galectin-3 Test for Use in Patients with Chronic Heart Failure …
Interpreting Galectin-3 Results …
Image credit: Wellcome Images: Illustration depicting the concept of ‘heart pain’ in angina pectoris.
Your information will never be shared with any third party.