BG Medicine noted this week the publication of a study validating the analytical and clinical performance of an automated version of its BGM Galectin-3 heart failure test.
Published in Clinica Chimica Acta, the study used BioMérieux's VIDAS Galectin-3 assay, which the company has developed in partnership with BG, to analyze blood samples from 137 patients with chronic heart failure.
The study found that elevated galectin-3 levels as measured by the assay were predictive of fatal cardiovascular events and the severity of heart failure among these patients. It also found that the analytical performance of the automated assay matched that of the conventional, manual BGM Galectin-3 test.
In a statement, BG Medicine President and CEO Paul Sohmer said the results "support commercialization of the VIDAS Galectin-3 assay in Europe and substantiate our efforts to assist BioMérieux with its pursuit of [US Food and Drug Administration] 510(k) clearance of the assay in the US."