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

Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care.

Galectin-3 is a protein that is involved in fundamental disease processes, including the development of fibrosis in organ tissues and cardiac remodeling, which may lead to the development and progression of heart failure.

An automated blood test was officially cleared by the United States Food and Drug Administration (FDA; Silver Springs, MD, USA) for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. 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