Mitochondrial protease oma1 as a marker for breast cancer

Abstract

The use of mitochondrial protease OMA1 as a theranostic marker for breast cancer, tumor progression, metastatis and drug responsiveness is disclosed herein.

What is claimed is: 
     
         1 . A method of diagnosing metastatic breast cancer in a subject in need thereof, the method comprising:
 measuring an expression level of protein OMA1 Zinc Metallopeptidase (OMA1) in a sample obtained from the subject; and   comparing the expression level of protein OMA1 in the sample with a protein OMA1 reference expression level, wherein the expression level of protein OMA1 in the sample less than the protein OMA1 reference expression level indicates metastatic breast cancer.   
     
     
         2 . The method according to  claim 1 , wherein said sample is selected from the group consisting of serum, plasma, and whole blood. 
     
     
         3 . The method according to  claim 1 , wherein the measuring comprises:
 contacting a portion of the sample obtained from the patient with an antibody having specific binding affinity for protein OMA1, thereby forming a complex between the antibody and protein OMA1 in the sample;   separating the complex formed in said step of contacting from antibody not bound to protein OMA1; and   quantifying a signal from the complex between the antibody and protein OMA1, the signal being proportional to the expression level of protein OMA1 in the sample obtained from the subject.   
     
     
         4 . The method according to  claim 1 , wherein said step of measuring comprises an immunoassay procedure. 
     
     
         5 . The method according to  claim 4 , wherein the immunoassay procedure comprises an enzyme-linked immunoassay (ELISA). 
     
     
         6 . The method according to  claim 4 , wherein the immunoassay procedure comprises a sandwich assay format. 
     
     
         7 . A method of monitoring effectiveness of a therapy in a subject having or suspected of having a metastatic breast cancer, the method comprising: measuring an expression level of protein OMA1 Zinc Metallopeptidase (OMA1) in at least a first chronological sample obtained from the subject; administering the therapy; measuring an expression level of protein OMA1 Zinc Metallopeptidase (OMA1) in at least a second chronological sample obtained from the subject, analyzing the expression level of protein OMA1 Zinc Metallopeptidase (OMA1) in at least the first chronological sample and the expression level of protein OMA1 Zinc Metallopeptidase (OMA1) in at least the second chronological sample, wherein an increase in the expression level of protein OMA1 Zinc Metallopeptidase (OMA1) in the second chronological sample as compared to the expression level of protein OMA1 Zinc Metallopeptidase (OMA1) in a first chronological sample indicates effectiveness of the therapy. 
     
     
         8 . The method according to  claim 7 , wherein the therapy is a chemotherapeutic.