Systems and Methods for Anti-PAX8 Antibodies

Abstract

The present invention is related to the anti-PAX8 antibodies, kits, cocktails, and use of anti-PAX8 antibodies for detection of cancer.

1 - 23 . (canceled) 
     
     
         24 . An antibody or fragment thereof that binds specifically to PAX8 comprising heavy chain variable region complementarity determining region (CDR) sequences set forth as SEQ ID NOs: 4, 5, and 6; and light chain variable region CDR sequences set forth as SEQ ID NOs: 7, 8 and 9. 
     
     
         25 . An antibody or fragment thereof according to  claim 24  that specifically binds to at least one polypeptide with an amino acid sequence comprising residues of SEQ ID NO: 3. 
     
     
         26 . An antibody or fragment thereof according to  claim 24  wherein said antibody or said fragment thereof comprises a light chain variable region comprising the amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO: 2 and a heavy chain variable region comprising the amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO: 1. 
     
     
         27 . An antibody or fragment thereof according to  claim 24  wherein said antibody or said fragment thereof which binds specifically to at least PAX8 comprises an antibody or fragment thereof which binds specifically to at least PAX8 and does not bind to B-cells. 
     
     
         28 . A composition comprising at least two antibodies or fragments thereof, wherein said at least one of said at least two antibodies or fragments thereof comprises said antibody or said fragments thereof having the CDR regions according to  claim 24 . 
     
     
         29 . A composition according to  claim 28  wherein said at least one other of said at least two antibodies or fragments thereof binds specifically to an antigen selected from a group consisting of GATA-3, p63, PSA, ER, Mammaglobin, GCDFP-15, NKX3.1, Napsin A, TTF-1, CK20, CDX2, ERG, and any combination thereof. 
     
     
         30 . A composition according to  claim 28  wherein said at least two antibodies or fragments thereof each bind specifically to proteins selected from a group consisting of:
 PAX8 and GATA-3; 
 PAX8 and p63; 
 PAX8 and PSA; 
 PAX8 and PSA and GATA-3; 
 PAX8 and ER and Mammoglobin and GCDFP-15; 
 PAX8 and ER; 
 PAX8 and Mammoglobin; 
 PAX8 and GCDFP-15; 
 PAX8 and NKX3.1; 
 PAX8 and Napsin A and TTF-1; 
 PAX8 and Napsin A; 
 PAX8 and TTF-1; 
 PAX8 and CD20 and CDX2; 
 PAX8 and CD20; 
 PAX8 and CDX2; 
 PAX8 and ERG and GATA-3; and 
 PAX8 and ERG. 
 
     
     
         31 . A composition according to  claim 28  wherein said at least two antibodies or fragments thereof are derived from at least two different species. 
     
     
         32 . A composition according to  claim 31  wherein said at least two different species is selected from a group consisting of mouse, rabbit, goat, horse, chicken, human, and any combination thereof. 
     
     
         33 . A composition according to  claim 28  wherein said at least two antibodies or fragments thereof comprises a double-stain procedure. 
     
     
         34 . A composition according to  claim 28  wherein said at least two antibodies or fragments thereof are capable of providing different visualization results. 
     
     
         35 . A composition according to  claim 34  wherein said visualization results comprises color results. 
     
     
         36 . An antibody according to  claim 24  wherein said antibody comprises a monoclonal antibody. 
     
     
         37 . An antibody according to  claim 36  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, a chimeric antibody, and any combination thereof. 
     
     
         38 . An antibody according to  claim 24  wherein said antibody comprises an isolated antibody. 
     
     
         39 . An antibody according to  claim 24  wherein said fragment thereof comprises an antigen binding fragment thereof. 
     
     
         40 . An antibody according to  claim 24  and further comprising a label attached to said antibody or fragment thereof. 
     
     
         41 . An antibody according to  claim 40  wherein said label is selected from a group consisting of a radioactive element, magnetic particles, radioisotope, fluorescent dye, enzyme, toxin, signal, stain, and any combination thereof. 
     
     
         42 . A method for detecting PAX8 in a biological sample comprising the steps of:
 contacting a biological sample with said antibody or fragment thereof according to  claim 24 ; and   detecting binding of said antibody with an antigen in said biological sample using said antibody detection element.   
     
     
         43 . A method according to  claim 42  wherein said biological sample is selected from a group consisting of a normal tissue, neoplastic tissue, kidney tissue, ovarian tissue, thyroid tissue, endometrial tissue, renal tissue, tonsil tissue, pancreas tissue, colon tissue, lymph node tissue, neoplastic pancreatic tissue, stomach tissue, bladder tissue, prostate tissue, lung tissue and breast tissue. 
     
     
         44 . A method according to  claim 42  wherein said detecting comprises a method selected from a group consisting of immunohistochemistry (IHC), IHC of FFPE, ICH of frozen-tissue sections, and ELISA. 
     
     
         45 . An antibody or fragment thereof according to  claim 24  wherein said antibody or said fragment thereof comprises a light chain variable region comprising an amino acid sequence at least about 90% identical to an amino acid sequence encoded by a nucleic acid sequence of SEQ ID NO: 2. 
     
     
         46 . An antibody or fragment thereof according to  claim 24  wherein said antibody or said fragment thereof comprises a heavy chain variable region comprising an amino acid sequence at least about 90% identical to an amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO: 1.