Methods and compositions for the detection of cervical disease
First Claim
1. A method for diagnosing high-grade cervical disease in a patient independent of the patient'"'"'s HPV infection status, the method comprising:
- a) obtaining a body sample from the patient;
b) contacting the sample with at least three antibodies, wherein each of the antibodies specifically binds to a nuclear biomarker protein that is selectively overexpressed in high-grade cervical disease, wherein a first and a second antibody specifically bind to the biomarker protein MCM2, and wherein a third antibody specifically binds to the biomarker protein Topo2A; and
,c) detecting binding of the antibodies to the biomarker proteins MCM2 and Topo2A to determine if the biomarker proteins are overexpressed in the sample, and thereby diagnosing high-grade cervical disease in the patient.
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Abstract
Methods and compositions for identifying high-grade cervical disease in a patient sample are provided. The methods of the invention comprise detecting overexpression of at least one biomarker in a body sample, wherein the biomarker is selectively overexpressed in high-grade cervical disease. In particular claims, the body sample is a cervical smear or monolayer of cervical cells. The biomarkers of the invention include genes and proteins that are involved in cell cycle regulation, signal transduction, and DNA replication and transcription. In particular claims, the biomarker is an S-phase gene. In some aspects of the invention, overexpression of a biomarker of interest is detected at the protein level using biomarker-specific antibodies or at the nucleic acid level using nucleic acid hybridization techniques. Kits for practicing the methods of the invention are further provided.
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Citations
14 Claims
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1. A method for diagnosing high-grade cervical disease in a patient independent of the patient'"'"'s HPV infection status, the method comprising:
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a) obtaining a body sample from the patient; b) contacting the sample with at least three antibodies, wherein each of the antibodies specifically binds to a nuclear biomarker protein that is selectively overexpressed in high-grade cervical disease, wherein a first and a second antibody specifically bind to the biomarker protein MCM2, and wherein a third antibody specifically binds to the biomarker protein Topo2A; and
,c) detecting binding of the antibodies to the biomarker proteins MCM2 and Topo2A to determine if the biomarker proteins are overexpressed in the sample, and thereby diagnosing high-grade cervical disease in the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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Specification