Micrornas differentially expressed in cervical cancer and uses thereof

• US 8,361,714 B2
• Filed: 09/12/2008
• Issued: 01/29/2013
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Asuragen, Inc.
• Original Assignee: Asuragen, Inc.
• Inventors: Beaudenon-Huibregtse, Sylvie, Labourier, Emmanuel, Elizondo, Laura
• Primary Examiner(s): GIBBS, TERRA C
• Application Number:
  US12/209,822
• Publication Number:
  US 20090186348A1
• Time in Patent Office: 1,600 Days
• Field of Search: 435/6, 435/325, 435/375, 435/91.1
• US Class Current: 435/6.1
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/112 Disease subtyping, staging or classification
• CPC Class Codes: C12Q 2600/178 miRNA, siRNA or ncRNA

Abstract

The present invention concerns methods and compositions for identifying a miRNA profile for a particular condition, such as cervical disease, and using the profile in assessing the condition of a patient.

Claims

1. A method for identifying a biomarker indicative of cervical precancer or cancer in a patient comprising measuring an expression profile of one or more miRNAs in a cervical sample from a patient suspected of having a precancerous or cancerous cervical condition and identifying the patient as having a biomarker indicative of cervical precancer or cancer after measuring a decrease in hsa-miR-1 (SEQ ID NO:

87) expression compared to an expression profile of a normal cervical sample.

2. The method of claim 1, wherein the expression profile comprises a second miRNA that is hsa-miR-21 (SEQ ID NO:

183), hsa-miR-224 (SEQ ID NO;

199), hsa-miR-15b (SEQ ID NO;

139), or hsa-miR-21*(SEQ ID NO;

486).

3. The method of claim 1, wherein the patient is identified as having a biomarker indicative of cervical cancer based on measuring a reduced expression of hsa-miR-1 in the patient'"'"'s sample.

4. The method of claim 2, wherein the expression profile shows increased expression of hsa-miR-21, hsa-miR-224, hsa-miR-15b, or hsa-miR-21* in the sample relative to the expression level of normal sample.

5. The method of claim 4, wherein increased expression of hsa-miR-21 is measured in the sample relative to the normal sample.

6. The method of claim 1, wherein the sample from the patient is isolated RNA, fresh tissue or cells, frozen tissue or cells, fixed tissue or cells, or embedded tissue or cells.

7. The method of claim 1, wherein the cervical precancer is cervical squamous intraepithelial lesion or cervical intraepithelial neoplasia.

8. The method of claim 1, wherein the cervical cancer is cervical squamous cell carcinoma.

9. The method of claim 1, further comprising obtaining the cervical sample from the patient.

10. The method of claim 1, further comprising labeling miRNA from the cervical sample.

11. The method of claim 10, further comprising hybridizing the labeled miRNA to one or more miRNA probes.

12. The method of claim 1, wherein the expression profile of the one or more miRNA is determined by an amplification assay or a hybridization assay.

13. The method of claim 12, wherein the one or more miRNA is all or part of one or more of hsa-miR-1, hsa-miR-15b, hsa-miR-133a, hsa-miR-143, hsa-miR-205, hsa-miR-21, hsa-miR-204, hsa-miR-195, hsa-miR-100, hsa-miR-99a, hsa-miR-368, hsa-miR-183, hsa-miR-224, hsa-miR-21* or combination thereof.