# US 9,684,001 B2 · Biomarkers for head-and-neck cancers and precancers

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- Number: US 9,684,001 B2
- Document ID: US9684001B2
- Status: Granted
- Kind: B2
- Application number: 14/028,287
- Filed: 2013-09-16
- Published: 2014-03-20
- Granted: 2017-06-20
- Earliest claimed: 2013-09-16
- Applicants: Ranju Ralhan; Paul G. Walfish
- Inventors: Ranju Ralhan; Paul G. Walfish
- Web page: https://patentgrep.com/patent/US9684001B2

## 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 of concurrently detecting levels of nuclear prothymosin alpha, PTMA, and cytoplasmic psoriasin, S100A7, in a biological sample obtained from a subject having moderate or severe grade oral dysplasia, the method comprising:
concurrently contacting the biological sample with a first binding agent that specifically binds to prothymosin alpha, PTMA, and a second binding agent that specifically binds to psoriasin, S100A7, wherein the biological sample is an oral tissue sample, a cytosmear, saliva or a combination thereof; and,
detecting the level of nuclear PTMA and the level of cytoplasmic S100A7 in the sample by measuring the amount of PTMA and S100A7 bound to the first and second binding agents, respectively.

### 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 3)

The method of claim 3, wherein at least one of the first binding agent and the second binding agent is an antibody.

### Claim 5 (depends on 1)

The method of claim 1, wherein the step of detecting the level of nuclear PTMA and the level of cytoplasmic S100A7 is conducted using immunohistochemistry (IHC).

### Claim 6 (depends on 4)

The method of claim 4, wherein the step of detecting the level of nuclear PTMA and the level of cytoplasmic S100A7 is conducted using immunohistochemistry (IHC).