# US 2014/0080138 A1 · Biomarkers for Head-and-Neck Cancers and Precancers

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2014/0080138 A1
- Document ID: US20140080138A1
- Status: Published application
- Kind: A1
- Application number: 14/028,287
- Filed: 2013-09-16
- Published: 2014-03-20
- Earliest claimed: 2008-02-07
- Inventors: Ranju Ralhan; Paul G. Walfish
- Web page: https://patentgrep.com/patent/US20140080138A1

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- G01N 2333/4727: Calcium binding proteins, e.g. calmodulin
- G01N 2333/5759: Thymosin or related peptides
- 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 markers and methods for detecting head-and-neck precancers, (including OPLs), cancers and related disease conditions in a subject. The invention also provides localization and imaging methods for head-and-neck precancers (including OPLs) and cancers, along with kits for carrying out methods of the invention. The invention further provides therapeutic applications for head-and-neck precancers (including OPLs) and cancers which employ head-and-neck precancer and cancer markers, and binding agents for the markers. Methods of identifying a subject having oral dysplasia that is at high risk of malignant transformation are provided.

## Claims

### Claim 1

A method for diagnosing an increased risk for development of oral cancer in a subject having oral dysplasia, the method comprising:
measuring the level of S100A7 in a biological sample from the subject; and
comparing the level of S100A7 in the biological sample with the level of S100A7 in a control, wherein a measured level of S100A7 higher than the control level is indicative of an increased risk for developing oral cancer.

### Claim 2 (depends on 1)

The method of claim 1, wherein the biological sample comprises epithelial cells.

### Claim 3 (depends on 2)

The method of claim 2, wherein the epithelial cells are dysplastic.

### Claim 4 (depends on 2)

The method of claim 2, wherein the biological sample is a cytosmear.

### Claim 5 (depends on 1)

The method of claim 1, wherein the control is a biological sample comprising dysplastic epithelial cells known not to progress to oral cancer for at least 3.5 years following measurement of the control level.

### Claim 6 (depends on 5)

The method of claim 5, wherein the biological sample known not to progress to cancer is known to progress to cancer for at least 10 years following measurement of the control level.

### Claim 7

A method for diagnosing an increased risk for development of oral cancer in a subject having oral dysplasia, the method comprising:
measuring the level of nuclear PTMA in a biological sample from the subject; and
comparing the level of nuclear PTMA in the biological sample with the level of nuclear PTMA in a control, wherein a measured level of nuclear PTMA higher than the control level is indicative of an increased risk for developing oral cancer.

### Claim 8 (depends on 7)

The method of claim 7, further comprising:
measuring the level of cytoplasmic S100A7 in a biological sample from the subject; and
comparing the level of cytoplasmic S100A7 in the biological sample with the level of cytoplasmic S100A7 in a control, wherein a measured level of cytoplasmic S100A7 higher than the control level is indicative of an increased risk for developing cancer.

### Claim 9 (depends on 7)

The method of claim 7, wherein the biological sample comprises epithelial cells.

### Claim 10 (depends on 9)

The method of claim 9, wherein the epithelial cells are dysplastic.

### Claim 11 (depends on 9)

The method of claim 9, wherein the biological sample is a cytosmear.

### Claim 12 (depends on 7)

The method of claim 7, wherein the control is a biological sample comprising dysplastic epithelial cells known not to progress to oral cancer for at least 3.5 years following measurement of the control level.

### Claim 13 (depends on 12)

The method of claim 12, wherein the biological sample known not to progress to cancer is known not to progress to cancer for at least 10 years following measurement of the control level.

### Claim 14 (depends on 8)

The method of claim 8, further comprising:
measuring the degree of dysplasia in the biological sample obtained from the subject, wherein a moderate or severe degree of dysplasia is indicative of an increased risk for developing oral cancer relative to a corresponding control sample having a mild degree of dysplasia.

### Claim 15 (depends on 8)

The method of claim 8, wherein the control is a biological sample comprising dysplastic epithelial cells known not to progress to oral cancer for at least 3.5 years following measurement of the control level.

### Claim 16 (depends on 15)

The method of claim 15, wherein the biological sample known not to progress to cancer is known not to progress to cancer for at least 10 years following measurement of the control level.