Galectin-3 Immunoassay

Abstract

The present invention relates to methods and compositions for specifically and quantitatively detecting galectin-3 in a sample. Embodiments of the invention include a detection assay in which a capture binding moiety and a labeled binding moiety specifically recognize non-overlapping epitopes on the N-terminus of galectin-3. Further embodiments are directed to a method for establishing ranges of galectin-3 concentrations indicative of the presence and severity of heart failure in a subject and a method for predicting the clinical outcome of a subject based upon galectin-3 concentration.

Description

REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61 / 109,366, filed Oct. 29, 2008, the complete disclosure of which is incorporated by reference herein.BACKGROUND OF THE INVENTION[0002]Heart failure (HF) is a major public health problem in the United States. Approximately 5 million people suffer from the disease and the number of patients is steadily increasing. HF is a common but severe and complex clinical syndrome, especially among elderly people. HF refers to a condition in which the heart fails to pump enough blood to meet the body's needs. Insufficient pumping leads to the congestion of blood and other fluid in the liver, abdomen, lower extremities, and lungs. Thus, HF has also been called congestive heart failure (CHF), although the term HF is preferred because not all patients exhibit fluid congestion. HF results in a gradual deterioration of the patient often leading to cardiovascular mortal...

AI Technical Summary

Benefits of technology

[0009]Methods for the detection of galectin-3 in clinical samples now have been identified and developed. It has now been discovered that the use of two binding moieties that bind specifically to at least two separate, non-overlapping epitopes on the N-terminus of galectin-3 can be used to produce various specific sandwich assay formats that can provide the reproducibility, specificity and sensitivity needed to diagnose and predict the outcome of subjects with HF. Accordingly, the present invention provides methods and kits for detecting the level of galectin-3 in a clinical sample. This permits improved management of the disease and provides diagnostic / prognostic information useful in its triage and management.

Problems solved by technology

Heart failure (HF) is a major public health problem in the United States.

Insufficient pumping leads to the congestion of blood and other fluid in the liver, abdomen, lower extremities, and lungs.

HF results in a gradual deterioration of the patient often leading to cardiovascular mortality.

Thus, a large number of patients die within one to five years after diagnosis.

Symptoms of HF include fatigue, weakness, rapid or irregular heartbeat, shortness of breath, persistent cough or wheezing, swelling of lower extremities or abdomen, sudden weight gain from fluid retention, lack of appetite or nausea, and chest pain.

However, other mechanisms that play a role in heart failure, such as inflammation, may not be reflected by an increase in BNP.

Current methods can reliably exclude HF, but cannot reliably prove the existence of HF, nor can they predict the outcome of established HF.

Assays for galectin-3 exist, but none are suitable for routine clinical use.

A suitable assay heretofore has eluded the art because of the complexity of galectin-3 as an analyte.

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