# US 8,999,659 B2 · Body fluid BIN1 as a marker of cardiac health

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- Number: US 8,999,659 B2
- Document ID: US8999659B2
- Status: Granted
- Kind: B2
- Application number: 13/879,329
- Filed: 2011-10-20
- Published: 2013-10-10
- Granted: 2015-04-07
- Earliest claimed: 2010-10-20
- Assignees: The Regents of the University of California
- Applicants: Robin Shaw; Ting-Ting Hong
- Inventors: Robin Shaw; Ting-Ting Hong
- Web page: https://patentgrep.com/patent/US8999659B2

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 33/6887: {from muscle, cartilage or connective tissue}
- G01N 2333/4706: stimulating, promoting or activating activity
- G01N 2800/325: Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
- G01N 2800/326: Arrhythmias, e.g. ventricular fibrillation, tachycardia, atrioventricular block, torsade de pointes
- G01N 2800/56: Staging of a disease; Further complications associated with the disease
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present disclosure provides methods involving use of BIN1 protein levels in biological fluid of a subject in evaluating cardiac health of the subject. The method provided herein may be used to predict a risk of a poor outcome in a subject. The methods also find use in evaluating subjects for assessing patients diagnosed with heart failure. These methods are also useful in assessing therapy options and efficacy of treatment in heart failure patients.

## Claims

### Claim 1

A method for assessing for presence of non-acute heart failure in a human subject at risk for heart failure, the method comprising:
measuring a cardiac BIN1 protein level in a blood, serum or plasma sample obtained from the subject, wherein the measuring is performed by contacting the blood, serum or plasma sample with an anti-cardiac BIN1 antibody;
comparing the cardiac BIN1 protein level to a normal cardiac BIN1 protein level; and
assessing the presence of non-acute heart failure in the subject when the cardiac BIN1 protein level is significantly decreased compared to the normal BIN1 protein level, wherein the normal cardiac BIN1 level is obtained from assaying cardiac BIN1 protein in a blood, serum or plasma sample obtained from a healthy human.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method further comprises determining a cardiac functional classification of the subject, wherein the cardiac BIN1 protein level is correlated with the cardiac functional classification.

### Claim 3 (depends on 1)

The method of claim 1, comprising measuring the cardiac BIN1 protein level in the blood sample.

### Claim 4 (depends on 1)

The method of claim 1, comprising measuring the cardiac BIN1 protein level in the serum sample.

### Claim 5 (depends on 1)

The method of claim 1, comprising measuring the cardiac BIN1 protein level in the plasma sample.

### Claim 6

A method of predicting a risk of poor cardiac outcome in a human subject at risk for non-acute heart failure, the method comprising:
measuring a cardiac BIN1 protein level in a blood, serum or plasma sample obtained from the subject wherein the measuring is performed by contacting the blood, serum or plasma sample with an anti-cardiac BIN1 antibody;
comparing the cardiac BIN1 protein level to a normal cardiac BIN1 protein level; and
predicting an increased risk of poor outcome when cardiac BIN1 protein level in the blood, serum or plasma sample is significantly decreased compared to the normal cardiac BIN1 protein level,
wherein the normal cardiac BIN1 level is obtained from assaying cardiac BIN1 protein in a blood, serum or plasma sample obtained from a healthy human.

### Claim 7 (depends on 6)

The method of claim 6, wherein increased risk of a poor outcome comprises increased risk of non-acute heart failure.

### Claim 8 (depends on 2)

The method of claim 2, wherein the determining a cardiac functional classification of the subject comprises:
classifying the subject into a higher cardiac functional class when the cardiac BIN1 protein level is within a first range of 60% to 45% of the normal cardiac BIN1 protein level, or
classifying the subject into a lower cardiac functional class when the cardiac BIN1 protein level is within a second range of 40% to 0% of the normal cardiac BIN1 protein level.

### Claim 9 (depends on 8)

The method of claim 8, wherein the higher cardiac functional class is New York Heart Association (NYHA) Class 1 or Class 2 and the lower cardiac functional class is NYHA Class 3 or Class 4.

### Claim 10

A method of predicting a risk of cardiac mortality in a human patient diagnosed with chronic heart failure, the method comprising:
measuring a cardiac BIN1 protein level in a blood, serum or plasma sample obtained from the patient wherein the measuring is performed by contacting the blood, serum or plasma sample with an anti-cardiac BIN1 antibody;
comparing the cardiac BIN1 protein level to a normal cardiac BIN1 protein level; and
predicting an increased risk of cardiac mortality when the cardiac BIN1 protein level in the blood, serum or plasma sample is significantly decreased compared to the normal cardiac BIN1 protein level,
wherein the normal cardiac BIN1 level is obtained from assaying cardiac BIN1 protein in a blood, serum or plasma sample obtained from a chronic heart failure human patient.