Automated Test for Galectin-3 Cleared for Chronic Heart Failure Prognosis

The test is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or plasma by enzyme linked immunosorbent assay (ELISA) on a microtiter plate platform.

The ARCHITECT Galectin-3 assay (Abbott Diagnostics; Abbot Park, IL, USA) is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and ethylenediaminetetraacetic acid (EDTA) plasma. The ARCHITECT Galectin-3 assay is performed using the Abbott ARCHITECT automated immunoassay analyzer and is being commercialized through an agreement between BG Medicine (Waltham, MA, USA) and Abbott. The ARCHITECT Galectin-3 assay is used with the ARCHITECT i System with STAT protocol capability.

Results should be interpreted along with clinical findings and other laboratory test results. Levels of galectin-3 in blood may be increased in patients with certain cancers and conditions associated with organ fibrosis. The ARCHITECT Galectin-3 assay is not indicated for detection, diagnosis, prognosis, or any uses associated with any type of cancer, conditions associated with organ fibrosis, or any other condition.

Paul R. Sohmer, MD, president and CEO of BG Medicine, Inc., said, “We believe that the introduction of automated galectin-3 testing will improve access to galectin-3 testing, shorten turn-around time for delivery of test results, and, as a result, accelerate adoption of galectin-3 testing in the United States.”

Related Links:
United States Food and Drug Administration 
Abbott Diagnostics 
BG Medicine