Method and kit for discriminating between breast cancer and benign breast disease

Abstract

A method and kit for discriminating between breast cancer and benign breast disease by the determination of the expression level of at least one target gene having a nucleic acid sequence selected from the nucleic acid sequences set forth in SEQ ID NOs: 1, 2 or 3, 4 and 5 or 6 to obtain an expression profile for the patient, and the comparison of the expression profile of the patient with expression profiles of target genes from patients previously clinically classified as breast cancer and expression profiles of target genes from patients previously clinically classified as benign breast disease.

1 . A method for discriminating between breast cancer and benign breast disease in a biological sample from a patient, the method comprising the following steps:
 a) obtaining the biological sample comprising a biological material from the patient,   b) contacting the biological material from the biological sample with at least one specific reagent for at least one target gene and no more than 28 specific reagents for 28 target genes comprising the full-length nucleic acid sequences set forth in SEQ ID NOS: 1 to 44, wherein the at least one reagent is specific for at least one target gene comprising the full-length nucleic acid sequence set forth in SEQ ID NOS: 1 to 6,   c) measuring the expression level of the at least one target gene to obtain an expression profile for the patient, and   d) performing clustering analysis of the expression profile of the patient with expression profiles of the at least one target gene from patients previously clinically classified as having breast cancer and expression profiles of the at least one target gene from patients previously clinically classified as having benign breast disease, wherein:
 if the expression profile of the patient is clustered with the expression profiles from patients previously clinically classified as having breast cancer, then the patient is diagnosed to have breast cancer, and 
 if the expression profile of the patient is clustered with the expression profiles from patients previously clinically classified as having benign breast disease, then the patient is diagnosed to have a benign breast disease. 
   
     
     
         2 . The method as claimed in  claim 1 , wherein:
 in step b) the biological material from the biological sample is contacted with reagents specific for a combination of at least 4 and no more than 28 target genes, the at least four reagents being specific for at least four different target genes respectively comprising the full-length nucleic acid sequences set forth in:
 1) SEQ ID NO: 1; and 
 2) SEQ ID NO: 2 or 3; and 
 3) SEQ ID NO: 4; and 
 4) SEQ ID NO: 5 or 6; and 
   the expression level of the target genes is measured in step c) to obtain the expression profile for the patient.   
     
     
         3 . The method as claimed in  claim 1 , wherein in step b) the biological material is brought into contact with reagents specific for a combination of 28 target genes, and the expression level of the 28 genes is measured in step c) to obtain the expression profile for the patient. 
     
     
         4 . The method as claimed in  claim 1 , wherein the biological sample taken from the patient is a blood sample. 
     
     
         5 . The method as claimed in  claim 1 , wherein the biological material comprises nucleic acids. 
     
     
         6 . The method as claimed in  claim 1 , wherein the at least one specific reagent of step b) comprises at least one hybridization probe. 
     
     
         7 . The method as claimed in  claim 6 , wherein the specific reagents of step b) comprises at least one hybridization probe and at least one primer. 
     
     
         8 . The method as claimed in  claim 7 , wherein the specific reagents of step b) comprises one hybridization probe and two primers. 
     
     
         9 . A kit for discriminating breast cancer from benign breast disease in a biological sample from a patient, comprising at least one specific reagent for at least one target gene and no more than 28 specific reagents for 28 target genes comprising the full-length nucleic acid sequences set forth in SEQ ID NOS: 1 to 44, wherein the at least one reagent is specific for at least one target gene comprising the full-length nucleic acid sequence set forth in SEQ ID NOS: 1 to 6. 
     
     
         10 . The kit as claimed in  claim 9 , wherein the at least one specific reagent comprises at least four reagents respectively specific for at least four target genes and no more than 28 reagents, wherein the target genes are selected from the group consisting of genes comprising the full-length nucleic acid sequences set forth in SEQ ID NOS: 1 to 44, the at least four reagents being specific for at least four different target genes respectively comprising the full-length nucleic acid sequences set forth in:
 1) SEQ ID NO: 1; and   2) SEQ ID NO: 2 or 3; and   3) SEQ ID NO: 4; and   4) SEQ ID NO: 5 or 6.   
     
     
         11 . The kit as claimed in  claim 10 , comprising reagents specific for a combination of 28 target genes. 
     
     
         12 . A method comprising manufacturing the kit of  claim 9 . 
     
     
         13 . A method comprising manufacturing the kit of  claim 10 . 
     
     
         14 . A method comprising manufacturing the kit of  claim 11 . 
     
     
         15 . The method as claimed in  claim 12 , wherein the at least one specific reagent comprises at least one hybridization probe. 
     
     
         16 . The method as claimed in  claim 15 , wherein the at least one specific reagent comprises at least one hybridization probe and at least one primer. 
     
     
         17 . The method as claimed in  claim 16 , wherein the specific reagent comprises one hybridization probe and two primers.