Methods and Diagnostics for Cancer Detection and Treatment Monitoring

Abstract

Methods and diagnostic compositions for monitoring ER− breast cancer are disclosed. In some aspects, a method for detecting ER− breast cancer in a subject comprises obtaining a subject sample from a subject suffering from breast cancer; determining a level of NOHA in the subject sample; and comparing the level of NOHA obtained from the subject sample to the level of NOHA in a control sample, wherein a lower level of NOHA in the subject sample indicates presence of ER− breast cancer in the subject.

What is claimed is: 
     
         1 ) A method of detecting a level of NOHA in a subject, the method comprising:
 obtaining a subject sample from a subject;   detecting a level of NOHA in the subject sample by contacting the subject sample with a NOHA antibody, or an antigen-binding fragment thereof, and detecting binding between NOHA and the NOHA antibody or the antigen-binding fragment thereof; and   comparing the level of NOHA in the subject sample to a level of NOHA in a control sample to diagnose whether the subject has cancer.   
     
     
         2 ) The method of  claim 1 , wherein the control sample is based on ethnic origin of the subject. 
     
     
         3 ) The method of  claim 1 , wherein the control sample is based on an expected state of the ER− breast cancer in the subject. 
     
     
         4 ) The method of  claim 1 , wherein the detecting is achieved with an immunoassay selected from a group consisting of affinity capture assay, immunometric assay, heterogeneous chemiluminscence immunometric assay, homogeneous chemiluminscence immunometric assay, ELISA, western blotting, radioimmunoassay, magnetic immunoassay, real-time immunoquantitative PCR (iqPCR), SERS label free assay and combinations thereof. 
     
     
         5 ) The method of  claim 1  further comprising diagnosing the subject as having ER− breast cancer. 
     
     
         6 ) The method of  claim 1 , wherein the NOHA antibody comprises an amino acid sequence having at least 90% identity to SEQ ID NO: 1 and comprises amino acid sequence KTSTS corresponding to amino acids 91-95 of SEQ ID NO: 1. 
     
     
         7 ) The method of  claim 6 , wherein the NOHA antibody comprises a sequence having at least 95% amino acid sequence identity to SEQ ID NO: 1 and comprises amino acid sequence KTSTS corresponding to amino acids 91-95 of SEQ ID NO: 1. 
     
     
         8 ) The method of  claim 6 , wherein the NOHA antibody comprises a sequence having at least 98% amino acid sequence identity to SEQ ID NO: 1 and comprises amino acid sequence KTSTS corresponding to amino acids 91-95 of SEQ ID NO: 1. 
     
     
         9 ) A method of monitoring cancer in a subject, the method comprising:
 obtaining a first subject sample from a subject suffering from cancer;   detecting a level of NOHA in the first subject sample by contacting the first subject sample with a NOHA antibody, or an antigen-binding fragment thereof, and detecting binding between NOHA and the NOHA antibody or the antigen-binding fragment thereof; and   comparing the level of NOHA obtained from the first subject sample to a level of NOHA in a control sample.   
     
     
         10 ) The method of  claim 9  further comprising diagnosing the first subject with ER− breast cancer if the level of NOHA in the subject sample is lower than the level of NOHA in the control sample. 
     
     
         11 ) The method of  claim 9  further comprising:
 administering to the subject a treatment regimen; 
 obtaining a second subject sample subsequent to commencement of the treatment regimen; 
 detecting a level of NOHA in the second subject sample by contacting the second subject sample with a NOHA antibody, or an antigen-binding fragment thereof, and detecting binding between NOHA and the NOHA antibody or the antigen-binding fragment thereof; and 
 comparing the level of NOHA in the first subject sample and the second subject sample, wherein a higher level of NOHA in the second subject sample indicates the subject's responsiveness to the treatment regimen. 
 
     
     
         12 ) The method of  claim 11 , wherein the control sample is based on ethnic origin of the subject. 
     
     
         13 ) The method of  claim 9 , wherein the detecting is achieved with an immunoassay selected from a group consisting of affinity capture assay, immunometric assay, heterogeneous chemiluminscence immunometric assay, homogeneous chemiluminscence immunometric assay, ELISA, western blotting, radioimmunoassay, magnetic immunoassay, real-time immunoquantitative PCR (iqPCR), SERS label free assay and combinations thereof. 
     
     
         14 ) The method of  claim 9  further comprising diagnosing the subject as having ER− breast cancer. 
     
     
         15 ) The method of  claim 9 , wherein the NOHA antibody comprises an amino acid sequence having at least 90% identity to SEQ ID NO: 1 and comprises amino acid sequence KTSTS corresponding to amino acids 91-95 of SEQ ID NO: 1. 
     
     
         16 ) The method of  claim 9 , wherein the NOHA antibody comprises a sequence having at least 95% amino acid sequence identity to SEQ ID NO: 1 and comprises amino acid sequence KTSTS corresponding to amino acids 91-95 of SEQ ID NO: 1. 
     
     
         17 ) The method of  claim 9 , wherein the NOHA antibody comprises a sequence having at least 98% amino acid sequence identity to SEQ ID NO: 1 and comprises amino acid sequence KTSTS corresponding to amino acids 91-95 of SEQ ID NO: 1. 
     
     
         18 ) A kit for monitoring cancer in a subject, the kit comprising a NOHA antibody or an antigen-binding fragment thereof. 
     
     
         19 ) The kit of  claim 18  wherein the NOHA antibody comprises the amino acid sequence of SEQ ID NO: 1. 
     
     
         20 ) The kit of  claim 19 , wherein the NOHA antibody comprises an amino acid sequence having at least 90% identity to SEQ ID NO: 1 and comprises amino acid sequence KTSTS corresponding to amino acids 91-95 of SEQ ID NO: 1.