Methylation Biomarkers for Breast Cancer

Abstract

Different combinations of methylation status based biomarkers can be used to test for breast cancer with high sensitivity and high specificity.

1 . A highly specific and highly selective method of detecting breast cancer in a patient, comprising:
 obtaining a DNA sample from the patient; and   measuring, from the DNA sample, a methylation level in a regulatory region of each gene in a plurality of genes selected from the group consisting of: FOXC1, ARFGEF1, CREBBP, MSH6, ARHGEF7, GNG4, RPIA, SLC2A14, BTG3, EDNRB, PRDM16, SST, HS3ST2, ITGA9, CDH1, Hoxa7, BMP6, CD40, and TNFRSF8.   
     
     
         2 . The method of  claim 1 , further comprising comparing the measured methylation level for each of the plurality of genes to a respective threshold methylation level, and, based on the comparisons, detecting the presence or absence of breast cancer in the patient with high sensitivity and high specificity. 
     
     
         3 . The method of  claim 1 , wherein the plurality of genes includes nine or more of the genes listed in  claim 1 . 
     
     
         4 . The method of  claim 1 , wherein the DNA sample is obtained from a body fluid, wherein the body fluid is blood, serum, plasma, saliva, urine, stool, tissue, or a combination thereof. 
     
     
         5 . The method of  claim 1 , wherein the genes are the genes of BC Set 1: ARFGEF1, ARHGEF7, CD40, CDH1, CREBBP, HS3ST2, RPIA, SST, and TNFRSF8. 
     
     
         6 . The method of  claim 1 , wherein the genes are the genes of BC Set 2: ARFGEF1, ARHGE7, CD40, CDH1, HS3ST2, RPIA, SLC2A14, SST, and TNFRSF8. 
     
     
         7 . The method of  claim 1 , wherein the genes are the genes of BC Set 3: ARFGEF1, ARHGE7, CDH1, CREBBP, HS3ST2, RPIA, SLC2A14, SST, and TNFRSF8. 
     
     
         8 . The method of  claim 1 , wherein the genes are the genes of BC Set 4: ARFGEF1, CD40, CDH1, CREBBP, HS3ST2, RPIA, SLC2A14, SST, and TNFRSF8. 
     
     
         9 . The method of  claim 1 , wherein the genes are the genes of BC Set 5: ARFGEF1, CDH1, CREBBP, HS3ST2, PRDM16, RPIA, SLC2A14, SST, and TNFRSF8.