# US 2013/0157272 A1 · Methods and compositions involving mir-135b for distinguishing pancreatic cancer from benign pancreatic disease

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

- Number: US 2013/0157272 A1
- Document ID: US20130157272A1
- Status: Published application
- Kind: A1
- Application number: 13/615,066
- Filed: 2012-09-13
- Published: 2013-06-20
- Earliest claimed: 2011-09-13
- Assignees: Interpace Diagnostics Corporation
- Inventors: Alex Adai; Anna Szafranska-Schwarzbach; Bernard Andruss; Stephan Albrecht Hahn
- Web page: https://patentgrep.com/patent/US20130157272A1

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 1/6844: Nucleic acid amplification reactions
- C12Q 2600/158: Expression 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

Provided are methods and compositions for identifying a miRNA profile for a particular condition, such as pancreatic disease, and using the profile in assessing the condition of a patient.

## Claims

### Claim 1

A method for determining whether a patient has pancreatic ductal adenocarcinoma (PDAC) comprising:
a) measuring from a pancreatic sample from the patient the level of expression of at least two of the following diff pair miRNAs: miR-135b, miR148a, miR-130b, miR-196a, miR-24, miR-375, miR-96, miR-155, miR-21, miR-24, miR-201, miR-217, and miR-223, wherein at least one of the miRNAs is a biomarker miRNA and one is a comparative miRNA;
b) determining at least one biomarker diff pair value based on the level of expression of the biomarker miRNA compared to the level of expression of the comparative miRNA; and,
c) evaluating whether the pancreatic sample comprises PDAC cells based on the biomarker diff pair value(s).

### Claim 2

(canceled)

### Claim 3 (depends on 1)

The method of claim 1, wherein the level of at least five of the diff pair miRNAs are measured.

### Claim at position 4

-6. (canceled)

### Claim 7 (depends on 1)

The method of claim 1, wherein the pancreatic sample is a fine needle aspirate, a macrodissected sample, or a formalin-fixed paraffin embedded (PPFE) sample.

### Claim at position 6

-12. (canceled)

### Claim 13 (depends on 1)

The method of claim 1, wherein the level of at least miR-135b is measured.

### Claim at position 8

-25. (canceled)

### Claim 26 (depends on 1)

The method of claim 1, wherein a diff pair value is determined for at least one of the following diff pairs: miR-135b/mir-24; miR-130b/miR-135b; miR-135b/miR-148a; miR-148a/miR-196a; miR-375/miR-135b; miR-135b/miR-96; miR-155/miR-21 or miR-130b/miR-24.

### Claim 27 (depends on 26)

The method of claim 26, wherein a diff pair value is determined for miR-135b/mir-24.

### Claim at position 11

-36. (canceled)

### Claim 37 (depends on 1)

The method of claim 1, further comprising determining a risk score of PDAC for the patient.

### Claim at position 13

-39. (canceled)

### Claim 40 (depends on 1)

The method of claim 1, further comprising wherein the sample has undergone a cytology analysis prior to measuring the level of expression of any miRNA.

### Claim 41 (depends on 1)

The method of claim 1, further comprising treating the patient for PDAC if the patient is determined to be more likely to have PDAC than not to have PDAC.

### Claim at position 16

-44. (canceled)

### Claim 45

A method for characterizing pancreatic cells in a patient comprising determining the level of miR-135b expression in a biological sample comprising pancreas cells.

### Claim 46

(canceled)

### Claim 47 (depends on 45)

The method of claim 45, further comprising comparing the determined level of miR-135b expression in the biological sample to a normalized level of miR-135b in noncancerous pancreas cells.

### Claim 48 (depends on 45)

The method of claim 45 further comprising comparing the determined level of miR-135b expression in the biological sample to a determined level of a second miRNA in the biological sample.

### Claim 49 (depends on 48)

The method of claim 48, further comprising determining the level of expression of the second miRNA in the biological sample.

### Claim 50 (depends on 48)

The method of claim 48, wherein the level of the second miRNA is miR-148a, miR-130b, miR-196a, miR-24, miR-375, or miR-96.

### Claim 51 (depends on 45)

The method of claim 45, further comprising determining the level of miR-148a, miR-130b, miR-196a, miR-24, miR-375, or miR-96.

### Claim at position 24

-63. (canceled)

### Claim 64 (depends on 45)

The method of claim 45, further comprising determining the level of miR-24 expression in the biological sample.

### Claim 65 (depends on 64)

The method of claim 64, further comprising comparing the level of miR-135b expression to the level of miR-24 expression in the biological sample.

### Claim 66

(canceled)

### Claim 67 (depends on 45)

The method of claim 45, further comprising determining the level of expression of a second miRNA in the biological sample.

### Claim 68 (depends on 67)

The method of claim 67, wherein the level of expression of the second miRNA is miR-148a, miR-130b, miR-196a, miR-24, miR-375, or miR-96.

### Claim at position 30

-71. (canceled)

### Claim 72 (depends on 67)

The method of claim 67, further comprising determining the level of a third mRNA that is miR-148a, miR-130b, miR-196a, miR-24, miR-375, or miR-96.

### Claim at position 32

-191. (canceled)

### Claim 192

A method for identifying pancreatic cancer cells in a patient comprising:
a) obtaining a pancreatic sample from the patient,
b) from the pancreatic sample, measuring expression levels of at least miR-135b and at least one of the following miRNAs: miR-24, miR-96, miR-130b, miR-148a, miR-196a, or miR-375;
c) calculating a differential value between the level of miR-135b expression and a level of expression of a reference miRNA in the sample to provide at least one differential pair analysis factor; and
d) evaluating one or more differential pair analysis factors using a scoring algorithm to generate a risk score for the presence of pancreatic cancer cells in the pancreatic sample, wherein the patient is identified as having or as not having pancreatic cancer cells based on the score.

### Claim 193 (depends on 192)

The method of claim 192, wherein the expression level of miR-24 is measured to provide the expression level of a reference miRNA in the sample for calculating a differential value between the level of miR-135b expression and the level of expression of a reference miRNA in the sample to provide at least one differential pair analysis factor.

### Claim at position 35

-199. (canceled)

### Claim 200 (depends on 192)

The method of claim 192, further comprising:
(a) calculating a differential value between the level of miR-135b expression and the level of miR-24 expression to provide at least one differential pair analysis factor;
(b) calculating a differential value between the level of miR-135b expression and the level of miR-130b expression to provide at least one differential pair analysis factor;
(c) calculating a differential value between the level of miR-135b expression and the level of miR-148a expression to provide at least one differential pair analysis factor; and
(d) calculating a differential value between the level of miR-148a expression and the level of miR-196a expression to provide at least one differential pair analysis factor.

### Claim 201 (depends on 200)

The method of claim 200, further comprising:
(a) calculating a differential value between the level of miR-135b expression and the level of miR-375 expression to provide at least one differential pair analysis factor; and
(b) calculating a differential value between the level of miR-135b expression and the level of miR-96 expression to provide at least one differential pair analysis factor.

### Claim at position 38

-210. (canceled)