Novel diagnostic markers, especially for in vivo imaging, and assays and methods of use thereof

Abstract

Novel splice variants as diagnostic markers, preferably membrane-bound. The novel variants according to the present invention may optionally be used for diagnosis of Marker-detectable disease as described herein, optionally through immunohistochemistry.

1 . A monoclonal or polyclonal antibody or a fragment thereof comprising an antigen binding site capable of specifically binding to at least one epitope of the polypeptide comprising an amino acid sequence at least 90% identical to SEQ ID NO:599 or a fragment thereof. 
     
     
         2 . The antibody or fragment according to  claim 1  capable of specifically binding to the polypeptide comprising an amino acid sequence at least 95% identical to SEQ ID NO:599. 
     
     
         3 . The antibody or fragment according to  claim 1  capable of specifically binding to the polypeptide comprising the amino acid sequence set forth in SEQ ID NO:599. 
     
     
         4 . The antibody or fragment according to  claim 1  capable of specifically binding to the polypeptide consisting of the amino acid sequence set forth in SEQ ID NO:344 and does not substantially bind to known ST14 polypeptide having the amino acids sequence set forth in SEQ ID NO:338 or SEQ ID NO:594. 
     
     
         5 . The antibody or fragment according to  claim 1  wherein the antigen binding site contains contiguous or non-contiguous amino acids. 
     
     
         6 . The antibody or fragment according to  claim 1 , wherein the antibody is a fully human antibody, or a humanized or primatized antibody, or a chimeric antibody. 
     
     
         7 . The antibody or fragment according to  claim 1 , wherein the antibody comprises a fragment selected from the group consisting of Fab, Fab′, F(ab′)2, F(ab′), F(ab), Fv or scFv and minimal recognition unit. 
     
     
         8 . The antibody or fragment according to  claim 1 , wherein the antibody is coupled to a detectable marker or to a therapeutic substance. 
     
     
         9 . The antibody or fragment according to  claim 8 , wherein the detectable marker or the therapeutic substance is selected from the group consisting of an enzyme, a toxin, a chemotherapeutic agent, a radioisotope, a chelator, a fluorescent compound or a chemiluminescent compound. 
     
     
         10 . A pharmaceutical composition comprising the antibody or a fragment according to  claim 1  optionally with a carrier. 
     
     
         11 . A method of treating a patient having cancer, comprising administering to the patient an effective amount of the antibody or fragment according to  claim 1  or of a pharmaceutical composition comprising the antibody or fragment and a carrier. 
     
     
         12 . The method of  claim 11 , further comprising treating the patient with an additional treatment method for combination therapy, wherein the treatment method is selected from the group consisting of radiation therapy, additional antibody therapy and chemotherapy. 
     
     
         13 . The method of  claim 11 , wherein the cancer is selected from the group consisting of ovarian cancer, breast cancer, colon cancer, lung cancer, prostate cancer, and wherein the cancer is non-metastatic, invasive or metastatic. 
     
     
         14 . A method for in vivo imaging of tumors by contacting the tumor with the antibody or fragment according to  claim 1  and measuring differential expression of a polypeptide comprising the polypeptide sequence set forth in SEQ ID NO:599 or a fragment thereof, or a sequence at least about 90% identical to SEQ ID NO:599. 
     
     
         15 . A method for detecting a polypeptide comprising the amino acid sequence set forth in SEQ ID NO:599, or fragment, or a sequence at least 90% identical to SEQ ID NO:599 in a biological sample which comprises contacting the biological sample with the antibody or fragment according to  claim 1 . 
     
     
         16 . The method of  claim 15  wherein the biological sample is obtained from a human subject, and the contacting comprises contacting the subject or the sample with the antibody or fragment. 
     
     
         17 . A kit for any one of screening for a disease, diagnosing a disease, detecting the presence or a severity of a disease, prognosis of a disease, monitoring of disease progression or treatment efficacy or relapse of a disease, selecting a therapy for a disease, comprising the antibody or fragment according to  claim 1 . 
     
     
         18 . The kit according to  claim 17 , further comprising at least one immunoassay reagent. 
     
     
         19 . The kit according to  claim 18 , wherein the immunoassay is selected from the group consisting of an enzyme-linked immunosorbent assay (ELISA), an immunoprecipitation assay, an immunofluorescence analysis, an enzyme immunoassay (EIA), a radioimmunoassay (RIA), a Western blot assay, and a slot blot assay. 
     
     
         20 . The kit according to  claim 17 , wherein the disease is cancer selected from the group consisting of ovarian cancer, breast cancer, colon cancer, lung cancer, prostate cancer, and wherein the cancer is non-metastatic, invasive or metastatic.