# US 8,541,183 B2 · Methods of identification, assessment, prevention and therapy of lung diseases and kits thereof

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- Number: US 8,541,183 B2
- Document ID: US8541183B2
- Status: Granted
- Kind: B2
- Application number: 12/403,369
- Filed: 2009-03-12
- Published: 2010-01-14
- Granted: 2013-09-24
- Earliest claimed: 2007-09-11
- Assignees: Cancer Prevention and Cure, Ltd.
- Applicants: Robert T. Streeper; Elzbieta Izbicka; Sung H. Baek
- Inventors: Robert T. Streeper; Elzbieta Izbicka; Sung H. Baek
- Web page: https://patentgrep.com/patent/US8541183B2

## CPC

- G01N 33/5752: of the lungs
- 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 invention provides biomarkers and combinations of biomarkers that are useful in diagnosing lung diseases such as non-small cell lung cancer or reactive airway disease. The invention also provides methods of differentiating lung disease, methods of monitoring therapy, and methods of predicting a subject's response to therapeutic intervention based on the extent of expression of the biomarkers and combinations of biomarkers. Kits comprising agents for detecting the biomarkers and combination of biomarkers are also provided.

## Claims

### Claim 1

A method of physiological characterization in a subject comprising determining the extent of expression of at least three biomarkers from Table 1 in a physiological sample of said subject, wherein the extent of expression of said at least three biomarkers are indicative of a lung disease.

### Claim 2 (depends on 1)

The method of claim 1, wherein said lung disease is reactive airway disease.

### Claim 3 (depends on 2)

The method of claim 2, wherein said reactive airway disease is asthma.

### Claim 4 (depends on 1)

The method of claim 1, wherein said method comprises determining the extent of expression of at least four biomarkers from Table 1 in a physiological sample of said subject.

### Claim 5 (depends on 4)

The method of claim 4, wherein said biomarker is a polypeptide.

### Claim 6 (depends on 1)

The method of claim 1, wherein the physiological sample is biological fluid.

### Claim 7 (depends on 6)

The method of claim 6, wherein the biological fluid is blood serum or plasma.

### Claim 8 (depends on 1)

The method of claim 1, wherein the subject is a mammal.

### Claim 9 (depends on 8)

The method of claim 8, wherein the mammal is a human.

### Claim 10 (depends on 1)

The method of claim 1, wherein the method of determining the extent of expression comprises performing a quantitative multiplex immunoassay.

### Claim 11 (depends on 1)

The method of claim 1, wherein said method comprises determining the extent of expression of at least five biomarkers from Table 1 in a physiological sample of said subject.

### Claim 12 (depends on 1)

The method of claim 1, wherein said method comprises determining the extent of expression of at least six biomarkers from Table 1 in a physiological sample of said subject.

### Claim 13 (depends on 1)

The method of claim 1, wherein said lung disease is non-small cell lung cancer.

### Claim 14 (depends on 4)

The method of claim 4, wherein said lung disease is non-small cell lung cancer.

### Claim 15 (depends on 11)

The method of claim 11, wherein said lung disease is non-small cell lung cancer.

### Claim 16 (depends on 12)

The method of claim 12, wherein said lung disease is non-small cell lung cancer.

### Claim 17 (depends on 4)

The method of claim 4, wherein said lung disease is reactive airway disease.

### Claim 18 (depends on 17)

The method of claim 17, wherein said reactive airway disease is asthma.

### Claim 19 (depends on 11)

The method of claim 11, wherein said lung disease is reactive airway disease.

### Claim 20 (depends on 19)

The method of claim 19, wherein said reactive airway disease is asthma.

### Claim 21 (depends on 12)

The method of claim 12, wherein said lung disease is reactive airway disease.

### Claim 22 (depends on 21)

The method of claim 21, wherein said reactive airway disease is asthma.

### Claim 23 (depends on 1)

The method of claim 1, wherein the subject exhibits one or more symptoms of non-small cell lung cancer or reactive airway disease.

### Claim 24 (depends on 4)

The method of claim 4, wherein the subject exhibits one or more symptoms of non-small cell lung cancer or reactive airway disease.

### Claim 25 (depends on 1)

The method of claim 1, wherein the biomarkers comprise MIF; Leptin; IL-8; IL-12 (p40), free; or combinations thereof.

### Claim 26 (depends on 4)

The method of claim 4, wherein the biomarkers comprise MIF; Leptin; IL-8; and IL-12 (p40), free.

### Claim 27 (depends on 23)

The method of claim 23, wherein the biomarkers comprise MIF; Leptin; IL-8; IL-12 (p40), free; or combinations thereof.

### Claim 28 (depends on 24)

The method of claim 24, wherein the biomarkers comprise MIF; Leptin; IL-8; and IL-12 (p40), free.