BG Medicine (BGM), a privately-held developer of biomarker-based in vitro diagnostics, has launched new, CE-marked test for the measurement of galectin-3 in human plasma or serum, in the EU.
Galectin-3 has been shown by researchers at the University of Maastricht, the Netherlands, to play an integral role in the development and progression of heart failure.
The company said that Galectin-3 is a protein that is involved in the biological processes leading to cardiac fibrosis and scarring, which play a role in heart failure development and progression. Several studies have shown that galectin-3 may provide insight about heart failure and its underlying disease processes.
The BGM Galectin-3 test is available for clinical use in the EU and certain other European countries as an aid in the stratification of patients diagnosed with heart failure. The BGM Galectin-3 test is not available for sale or distribution in the US or Canada. The company has submitted a 510(k) application to obtain clearance from the FDA to sell the test in the US.
Pieter Muntendam, president and CEO of BG Medicine, said: “This is an important point in our development of galectin-3 testing and a milestone for the company. The objective of our BGM Galectin-3 test is to redefine heart failure on the basis of underlying disease processes, not as it is currently addressed based solely on the nature and severity of signs or symptoms.”