Methods for evaluating drug-resistance gene expression in the cancer patient
AssigneeOncoMEDx, Inc.
InventorMichael S. Kopreski
Life of this patent
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Abstract
The methods of the invention detect in a qualitative or quantitative fashion drug-resistance RNA and DNA in blood plasma, serum, and other bodily fluids. The methods of the invention thereby enable the assessment of drug resistance in a neoplasm without the requirement of a tissue biopsy. The inventive methods are useful for the evaluation, monitoring, and selecting of drug treatment regimens, and for determining a predisposition for or prognosis of chemoresistant neoplastic disease.
Claims48
A method for detecting extracellular DNA or RNA encoding all or a portion of a drug-reseistance-associated gene in blood plasma or serum from a human or animal with a neoplasm for evaluating, monitoring, predicting, treating, or making a determination of drug-resistance in the neoplasm, the method comprising the steps of:
- a) extracting extracellular mammalian DNA or RNA from blood plasma or serum of a human or animal with a neoplasm;
- b) amplifying or signal amplifying a portion of the extracted DNA, RNA or cDNA prepared therefrom, wherein said fraction comprises extracellular DNA or RNA from a drug-resistance-associated gene, and wherein amplification is performed qualitatively or quantitatively using primers or probes specific for said DNA, RNA or cDNA to produce an amplified product or signal;
- and
- c) detecting the amplified product or signal.
A method for detecting extracellular DNA or RNA encoding all or a portion of a drug-reseistance-associated gene in a bodily fluid from a human or animal with a neoplasm for evaluating, monitoring, predicting, treating, or making a determination of drug resistance in the neoplasm, the method comprising the steps of:
- a) extracting extracellular mammalian DNA or RNA from the bodily fluid of a human or animal with a neoplasm;
- b) amplifying or signal amplifying a portion of the extracted DNA, RNA or cDNA prepared therefrom, wherein said fraction comprises extracellular DNA or RNA from a drug-resistance-associated gene, and wherein amplification is performed qualitatively or quantitatively using primers or probes specific for said DNA, RNA or cDNA to produce an amplified product or signal;
- and
- c) detecting the amplified product or signal.
A method of evaluating or monitoring drug resistance in a neoplasm without obtaining tissue from the neoplasm, the method comprising the steps of:
- a) extracting extracellular mammalian DNA or RNA from blood plasma or serum of a human or animal with a neoplasm;
- b) amplifying or signal amplifying a portion of the extracted DNA, RNA or cDNA prepared therefrom, wherein said fraction comprises extracellular DNA or RNA from a drug-resistance-associated gene, and wherein amplification is performed qualitatively or quantitatively using primers or probes specific for said DNA, RNA or cDNA to produce an amplified product or signal;
- and
- c) detecting the amplified product or signal.
A method of evaluating or monitoring drug resistance in a neoplasm without obtaining tissue from the neoplasm, the method comprising the steps of:
- a) extracting extracellular mammalian DNA or RNA from the bodily fluid of a human or animal with a neoplasm;
- b) amplifying or signal amplifying a portion of the extracted DNA, RNA or cDNA prepared therefrom, wherein said fraction comprises extracellular DNA or RNA from a drug-resistance-associated gene, and wherein amplification is performed qualitatively or quantitatively using primers or probes specific for said DNA, RNA or cDNA to produce an amplified product or signal;
- and
- c) detecting the amplified product or signal.
A method for detecting extracellular DNA or RNA encoding all or a portion of a drug-reseistance-associated gene, or cDNA reverse-transcribed from said RNA, comprising the steps of extracting extracellular DNA or RNA encoding all or a portion of a drug-reseistance-associated gene DNA or RNA from blood plasma or serum, with or without converting said RNA to cDNA, hybridizing said DNA or RNA or cDNA to a detectably-labeled probe specific for said DNA or RNA or cDNA encoding all or a portion of a drug-resistance-associated gene, and detecting hybridization of DNA or RNA or cDNA encoding all or a portion of a drug-resistance-associated gene with the detectably-labeled probe.
A method for detecting extracellular DNA or RNA encoding all or a portion of a drug-reseistance-associated gene, or cDNA reverse-transcribed from said RNA, comprising the steps of extracting extracellular DNA or RNA encoding all or a portion of a drug-reseistance-associated gene DNA or RNA from a bodily fluid, with or without converting said RNA to cDNA, hybridizing said DNA or RNA or cDNA to a detectably-labeled probe specific for said DNA or RNA or cDNA encoding all or a portion of a drug-reseistance-associated gene, and detecting hybridization of DNA or RNA or cDNA encoding all or a portion of a drug-resistance-associated gene with the detectably-labeled probe.
A kit for the detection of DNA or RNA encoding all or a portion of a drug-resistance-associated gene, comprising amplification primers or probes specific for a drug-reseistance-associated gene DNA or RNA or cDNA produced therefrom.
Dependencies are inferred from the claim text.