# US 11,441,193 B2 · Biomarkers for head and neck cancer and methods of their use

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

- Number: US 11,441,193 B2
- Document ID: US11441193B2
- Status: Granted
- Kind: B2
- Application number: 16/857,767
- Filed: 2020-04-24
- Published: 2020-09-03
- Granted: 2022-09-13
- Earliest claimed: 2014-10-17
- Assignees: The Regents of the University of Colorado, a body corporate
- Applicants: The Regents of the University of Colorado, a body corporate
- Inventors: Shi-long Lu; John Song
- Web page: https://patentgrep.com/patent/US11441193B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 1/708: {for papilloma}
- C12Q 2600/154: Methylation markers
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q 2600/178: miRNA, siRNA or ncRNA
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Disclosed is a diagnostic panel of methylated genomic loci encoding microRNA (mgmiR) markers that demonstrated 90% sensitivity and 100% specificity in the detection of head and neck squamous cell carcinoma (HNSCC). These results represent the first use of quantitative MS-PCR for the detection of mgmiRs. In addition, this panel demonstrates the ability to detect hypermethylation in the adjacent mucosa of cancer patients, suggesting its utility in early detection. This panel is also capable of detecting cancer by using saliva, blood and FNA tissue samples.

## Claims

### Claim 1

A method for detecting head and neck cancer in a human subject, comprising
(a) preparing genomic DNA extract comprising a genomic locus encoding a microRNA (mgmiR) from a tissue or body fluid of said human subject, said genomic DNA extract comprising a first DNA fragment encompassing at least one genomic locus encoding at least one microRNA 124-2 said tissue or body fluid being selected from the group consisting of a head tissue, a neck tissue, mouth swab, nose swab, saliva, and combination thereof,
(b) generating a second DNA fragment by quantitative polymerase chain reaction (qPCR) using as a template said first DNA fragment and using as primers oligonucleotide pair having the sequence of SEQ ID Nos. 3 and 4 for microRNA 124-2,
(c) measuring the level of said second DNA fragment generated in step (b), and
(d) comparing the level of said second DNA fragment with a base level, said base level being the level of a corresponding DNA fragment generated by the same manner from the same tissue or body fluid of an individual known to be free from said cancer, wherein a significantly higher level of said second DNA fragment as compared to said base level is indicative of head and neck cancer in said human subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein said head and neck cancer is a head and neck squamous cell carcinoma (HNSCC).

### Claim 3 (depends on 1)

The method of claim 1, further comprising a step (e) of treating said human subject with a treatment method selected from the group consisting of surgery, chemotherapy, radiation therapy, and combination thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein a 100% higher level of said second DNA fragment as compared to the base level is indicative of presence of cancer.