# US 9,644,241 B2 · Methods and compositions involving miR-135B for distinguishing pancreatic cancer from benign pancreatic disease

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- Number: US 9,644,241 B2
- Document ID: US9644241B2
- Status: Granted
- Kind: B2
- Application number: 13/615,066
- Filed: 2012-09-13
- Published: 2013-06-20
- Granted: 2017-05-09
- Earliest claimed: 2011-09-13
- Assignees: Interpace Diagnostics Corporation
- Applicants: Alex Adai; Anna Szafransak-Schwarzbach; Bernard Andruss; Stephan Albrecht Hahn
- Inventors: Alex Adai; Anna Szafransak-Schwarzbach; Bernard Andruss; Stephan Albrecht Hahn
- Web page: https://patentgrep.com/patent/US9644241B2

## 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 of treating a patient that has pancreatic ductal adenocarcinoma (PDAC) comprising:
a) measuring by reverse-transcriptase polymerase chain reaction (RT-PCR) from a fine needle aspirate (FNA) pancreatic sample from the patient the level of expression of up to 11 different miRNAs that include at least miR-135b and at least 4 of the following diff pair miRNAs: miR148a, miR-130b, miR-196a, miR-24, miR-375, and miR-96, wherein at least one of the miRNAs is a biomarker miRNA and one is a comparative miRNA and miR-217 is not one of the miRNAs;
b) determining a diff pair value for diff pairs: miR135b/miR-24, miR130b/miR-135b; miR-135b/miR-148a; miR-148a/miR-196a; miR-135b/miR-96; miR-375/miR-135b and optionally miR-130b/miR-24 and,
c) analyzing the diff pair values using a computer performing linear discriminate analysis, wherein the linear discriminate identifies the patient as having PDAC; and
d) treating the identified patient with chemotherapy, radiotherapy, surgery, or immunotherapy to treat the PDAC.

### Claim 2 (depends on 1)

The method of claim 1, wherein the levels of at most 7 different miRNAs are measured.

### Claim 3 (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 4 (depends on 1)

The method of claim 1, wherein the treating comprises administering to the identified patient identified chemotherapy.

### Claim 5 (depends on 1)

The method of claim 1, wherein the treating comprises administering to the identified patient identified immunotherapy.