Biomarkers for the early detection of breast cancer
AssigneePresident and Fellows of Harvard College
InventorsJoshua LABAER, Karen Sue ANDERSON, Garrick WALLSTROM, Sahar SIBANI, Niroshan RAMACHANDRAN
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Abstract
The present invention provides reagents and methods for breast cancer detection.
Claims9
1-18. (canceled)
A method comprising:
- (a) contacting a serum or plasma sample obtained from a subject having, or at risk of having, breast cancer with a polynucleotide probe set bound to a surface of a solid support, wherein the polynucleotide probe set comprises two or more isolated polynucleotides selected from the group consisting of ATP6AP1 (SEQ ID NO:
- 14), PDCD6IP (SEQ ID NO:
- 22), DBT (SEQ ID NO:
- 26), CSNK1E (SEQ ID NO:
- 10), FRS3 (SEQ ID NO:
- 4), HOXD1 (SEQ ID NO:
- 8), SF3A1 (SEQ ID NO:
- 2), C15orf48 (SEQ ID NO:
- 36), MYOZ2 (SEQ ID NO:
- 34), BAT4 (SEQ ID NO:
- 6), BMX (SEQ ID NO:
- 46), RAB5A (SEQ ID NO:
- 24), UBAP1 (SEQ ID NO:
- 48), GPR157 (SEQ ID NO:
- 44), ZMYM6 (SEQ ID NO:
- 42), SLC33A1 (SEQ ID NO:
- 12), TRIM32 (SEQ ID NO:
- 38), ALG10 (SEQ ID NO:
- 28), TFCP2 (SEQ ID NO:
- 50), SERPINH1 (SEQ ID NO:
- 52), SELL (SEQ ID NO:
- 56), ZNF510 (SEQ ID NO:
- 54) or antigenic fragments thereof;
- wherein the contacting occurs under conditions whereby antibodies, if present in the bodily fluid, selectively bind to the polynucleotides bound to the surface;
- (b) detecting presence of antibodies to the polynucleotides in the sample;
- wherein the presence of antibodies in the sample to the two or more polynucleotides is used to diagnose breast cancer in the subject, and wherein detecting comprises normalizing intensities for each polynucleotide of the probe set and comparing normalized intensities with a control using partial area under a receiver operating characteristic curve (pAUC) with a false positive rate no greater than 5 percent;
- and
- (c) administering a therapeutic agent to the subject to treat the breast cancer.
The method of claim 1, wherein the one or more isolated polynucleotide comprises ATP6AP1 (SEQ ID NO:
- 13), or an antigenic fragment thereof.
The method of claim 1 wherein the subject has one or more of a lump in the breast tissue, lymph nodes, or armpit;
- changes in breast size or shape, skin dimpling, nipple inversion, spontaneous single-nipple discharge, a family/personal history of breast cancer, or the subject is a carrier of a mutation in the BRCA or other gene that predisposes the subject to breast cancer.
The method of claim 1, wherein the breast cancer is Stage I or Stage II breast cancer.
The method of claim 1, wherein the detecting comprises use of a labeled antibody.
The method of claim 1, wherein the subject is further tested for the presence of breast cancer using a technique selected from the group consisting of mammography, biopsy, or magnetic resonance imaging.
The method of claim 1, wherein the polypeptide probe set further comprises two or more additional polypeptides selected from the group recited in claim 1.
The method of claim 1, wherein each polynucleotide of the polynucleotide probe set is bound to the surface using Nucleic Acid Programmable Protein Array (NAPPA) technology.
Dependencies are inferred from the claim text.