Methods and compositions involving miR-135B for distinguishing pancreatic cancer from benign pancreatic disease

• US 9,644,241 B2
• Filed: 09/13/2012
• Issued: 05/09/2017
• Est. Priority Date: 09/13/2011
• Status: Active Grant

• Current Assignee: Redpath Equityholder Representative, Llc
• Original Assignee: Interpace Diagnostics LLC (Interpace Biosciences, Inc.)
• Inventors: Adai, Alex, Andruss, Bernard, Hahn, Stephan Albrecht, Szafransak-Schwarzbach, Anna
• Primary Examiner(s): SCHNIZER, RICHARD A
• Application Number:
  US13/615,066
• Publication Number:
  US 20130157272A1
• Time in Patent Office: 1,699 Days
• Field of Search: None
• CPC Class Codes: C12Q 1/6844 Nucleic acid amplification reactions
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: C12Q 2600/178 miRNA, siRNA or ncRNA

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

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.

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

3. 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.

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

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