Abbott, Abbott Park, Ill, has received CE Marking for the ARCHITECT Galectin-3 assay, a test to aid physicians in assessing the prognosis of patients diagnosed with chronic heart failure.
The test was developed in partnership with BG Medicine Inc, Waltham, Mass, to run on Abbott’s ARCHITECT immunochemistry platform. Abbott expects to submit a 510(k) clearance application for the assay some time this year, and anticipates introducing the assay in the United States next year.
“Galectin-3 reflects the pathophysiology of heart failure and is one of the most powerful prognostic indicators in heart failure,” says Rudolf de Boer, MD, PhD, associate professor of cardiology, University Medical Centre Groningen, the Netherlands. “It helps clinicians identify which patients are at high risk for worsening heart failure early in the course of their disease. Knowing which patients are at increased risk of hospital readmission – independent of other variables – could provide physicians with important information to help them reach different decisions about treatment, which may benefit patient care.”
|The ARCHITECT Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and EDTA plasma on the ARCHITECT i System. It may be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.|
While the progress of heart failure is different for each patient, several studies demonstrate that those with higher levels of a protein called galectin-3 present are more likely to have worse outcomes, including re-hospitalization and death.[iv]
“Despite numerous medical advances, the number of deaths among hospitalized heart failure patients remains high, exceeding that of most cancers,” says Brian Blaser, executive vice president, Diagnostics Products, Abbott. “The new ARCHITECT Galectin-3 test is a helpful tool to aid physicians in their care of these critically ill patients.”