Anti-Uroplakin II antibodies systems and methods

1. An isolated antibody or isolated antigen binding fragment thereof comprising: heavy chain variable region complementarity determining region (CDR) sequences consisting of SEQ ID NOs: 5, 6, and 7; and

light chain variable region CDR sequences consisting of SEQ ID NOs: 8, 9, and 10 or SEQ ID NOs: 11, 12, and 13,

wherein the antibody or antigen binding fragment thereof specifically binds to Uroplakin II comprising SEQ ID NO: 4.

2. The antibody according to claim 1 wherein said antibody comprises a monoclonal antibody.

3. The antibody according to claim 2 wherein said monoclonal antibody is selected from a group consisting of a mouse monoclonal antibody, a rabbit monoclonal antibody, a goat monoclonal antibody, a horse monoclonal antibody, a chicken monoclonal antibody, a humanized monoclonal antibody and a chimeric antibody, and any combination thereof.

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

5. The antibody according to claim 4 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.

6. 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.

7. The composition according to claim 6 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.

8. An immunoassay method for detecting Uroplakin II in a biological sample comprising:

(a) contacting the biological sample with the isolated antibody or isolated antigen binding fragment thereof of claim 1 wherein the antibody or antigen fragment thereof specifically binds Uroplakin II comprising SEQ ID NO: 4 to form a complex; and

(b) detecting the complex,

wherein the immunoassay is selected from the group consisting of immunohistochemistry (IHC), IHC of FFPE, IHC of frozen-tissue sections, immunocytochemistry and ELISA.

9. The method according to claim 8 wherein said biological sample is selected from a group consisting of blood, urine, urothelial tissue, transitional cell tissue, 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.