Anti-uroplakin II antibodies systems and methods

1. An isolated antibody produced by the hybridoma deposited with the American Type Culture Collection (ATCC) under ATCC Patent Deposit Designation No. PTA-13181 or an isolated antigen binding fragment of the isolated antibody, wherein the antibody or antigen binding fragment thereof specifically binds Uroplakin II comprising SEQ ID NO: 4.

2. A hybridoma cell that is deposited at the American Type Culture Collection (ATCC) under ATCC Patent Deposit Designation No. PTA-13181.

3. The hybridoma cell according to claim 2 further comprising an antibody or antigen binding fragment thereof produced by said hybridoma cell.

4. A method for producing a monoclonal antibody according to claim 1 comprising the steps of:

culturing said hybridoma deposited with the American Type Culture Collection (ATCC) under ATCC Patent Deposit Designation No. PTA-13181 which produces a monoclonal antibody capable of specifically recognizing Uroplakin II; and

allowing said hybridoma to produce the monoclonal antibody.

5. A composition comprising the isolated antibody or isolated antigen binding fragment thereof of claim 1 and at least one additional isolated antibody or isolated antigen binding fragment thereof, wherein the at least one additional isolated antibody or isolated antigen binding fragment thereof specifically binds to an antigen selected from the group consisting of GATA-3, p63, Uroplakin III, PAX8, NKX3.1, PSA and p40.

6. The composition according to claim 5 wherein said isolated antibody or isolated antigen binding fragment thereof and said at least one additional isolated antibody or isolated antigen binding fragment thereof each bind specifically to proteins selected from a group consisting of:

Uroplakin II and GATA-3;

Uroplakin II and p63;

Uroplakin II and Uroplakin III;

Uroplakin II and PAX8;

Uroplakin II and NKX3.1;

Uroplakin II and PSA;

Uroplakin II and Uroplakin III and GATA-3;

Uroplakin II and PAX8 and PSA;

Uroplakin II and PAX8 and NKX3.1; and

Uroplakin II and p40.

7. The isolated antibody or isolated antigen binding fragment thereof of claim 1 , wherein the isolated antibody or isolated antigen is conjugated with a label.

8. An antibody according to claim 7 wherein said label is selected from a group consisting of a radioactive element, magnetic particles, radioisotope, fluorescent dye, enzyme, toxin, signal, stain, detection enzymes, horseradish peroxidase (HRP), alkaline phosphatase (AP), beta-galactosidase, chromogens, Fast Red, 3,3′-diaminobenzidine, 3-amino-9-ethylcarbazole, 5-bromo-4-chloro-3-indolyl phosphate, 3,3′,5,5′-tetramethylbenzidine, 5-bromo-4-chloro-3-indolyl-β-D-glucuronide, and any combination thereof.

9. A kit comprising:

the isolated antibody or isolated antigen binding fragment thereof of claim 1 ; and

an antibody detection reagent of said isolated antibody or isolated antigen binding fragment thereof of claim 1 , when bound the Uroplakin II antigen.

10. A method for detecting Uroplakin II in a biological sample comprising the steps of:

(a) providing the kit of claim 9 ; and

(b) detecting binding of said isolated antibody or said isolated antigen binding fragment thereof with the Uroplakin II antigen with an immunoassay comprising:

(i) contacting the biological sample with the isolated antibody or isolated antigen binding fragment thereof produced by hybridoma deposited with the American Type Culture Collection (ATCC) under ATCC Patent Deposit Designation No. PTA-13181, wherein the antibody or antigen fragment thereof specifically binds Uroplakin II comprising SEQ ID NO: 4 to form a complex; and

(ii) detecting the complex with the antibody detecting reagent provided in the kit, wherein the immunoassay is selected from the group consisting of immunohistochemistry (IHC), IHC of FFPE, IHC of frozen-tissue sections, immunocytochemistry, and ELISA.

11. The method according to claim 10 wherein said biological sample comprises blood, urine, urothelial tissue, transitional cell tissue, and bladder tissue.

12. The method according to claim 10 wherein said biological sample is selected from a group consisting of a normal tissue, neoplastic tissue, bladder tissue, kidney tissue, ovarian tissue, thyroid tissue, endometrial tissue, renal tissue, tonsil tissue, pancreas tissue, colon tissue, lymph node tissue, stomach tissue, prostate tissue, lung tissue and breast tissue.