Method enabling use of extracellular RNA extracted from plasma or serum to detect, monitor or evaluate cancer

A method for detecting a tumor-associated or tumor-derived RNA species in a plurality of RNA isolated from plasma or serum from a human or animal, wherein the tumor-associated or tumor-derived RNA is non-mutated RNA, the method comprising the steps of:

• a) extracting mammalian total RNA from plasma or serum, wherein a portion of the extracted RNA comprises a tumor-associated or tumor-derived mRNA species of a non-mutated gene;
• b) amplifying or signal amplifying the non-mutated mRNA or a cDNA produced therefrom to produce an amplified fragment or amplified signal, wherein amplification is performed qualitatively or quantitatively using primers or probes specific for the tumor-derived or tumor-associated, non-mutated mRNA or cDNA;
• and
• c) detecting quantitatively or qualitatively the amplified fragment or amplified signal produced from the tumor-derived or tumor-associated, non-mutated mRNA or cDNA.

A method for detecting tumor-associated or tumor-derived RNA in a non-cellular fraction of a bodily fluid from a human or animal, wherein the tumor-associated or tumor-derived RNA is RNA of a non-mutated gene, the method comprising the steps of:

• a) extracting total RNA from a non-cellular fraction of a bodily fluid from a human or animal, wherein a fraction of said extracted RNA comprises an RNA species of a non-mutated gene;
• b) amplifying or signal amplifying the non-mutated mRNA or a cDNA produced therefrom to produce an amplified fragment or amplified signal, wherein amplification is performed qualitatively or quantitatively using primers or probes specific for the tumor-derived or tumor-associated, non-mutated mRNA or cDNA;
• and
• c) detecting quantitatively or qualitatively the amplified fragment or amplified signal produced from the tumor-derived or tumor-associated, non-mutated mRNA or cDNA.

A method for detecting RNA in blood plasma or serum from a human or animal, wherein the RNA is a species that is detected in blood plasma or serum more frequently when the blood plasma or serum is obtained from an individual with cancer than when it is obtained from an individual without cancer, the method comprising the steps of:

• a) extracting total RNA from plasma or serum of a human or animal, wherein a fraction of said extracted RNA comprises an RNA species that is detected in blood plasma or serum more frequently when the blood plasma or serum is obtained from an individual with cancer than when it is obtained from an individual without cancer;
• b) amplifying or signal amplifying said species of RNA or cDNA prepared therefrom that is detected in blood plasma or serum more frequently when the blood plasma or serum is obtained from an individual with cancer than when it is obtained from an individual without cancer, to produce an amplified fragment or amplified signal, wherein amplification is performed qualitatively or quantitatively using primers or probes specific for the RNA or cDNA;
• and
• c) detecting quantitatively or qualitatively the amplified fragment or amplified signal produced from the RNA or cDNA species.

A method for detecting a plurality of RNA species in plasma or serum from a human or animal, the method comprising the steps of:

• a) extracting total RNA from plasma or serum of a human or animal, wherein said extracted RNA comprises a plurality of mammalian RNA species;
• b) amplifying or signal amplifying concurrently or sequentially at least two of said plurality of RNA or cDNA produced therefrom to thereby produce amplified fragments or amplified signals, wherein amplification is performed qualitatively or quantitatively using at least two primers or probes, each specific for an RNA species or cDNA produced therefrom;
• and
• c) detecting the amplified fragments or amplified signals produced from at least two of the amplified RNA species or cDNA produced therefrom.

A method for detecting a combination of RNA species in blood plasma or serum from a human or animal, wherein detection of said combination indicates a disease in the animal or human, the method comprising the steps of:

• a) extracting total RNA from plasma or serum from a human or animal, wherein said extracted RNA comprises a plurality of mammalian RNA species;
• b) amplifying or signal amplifying concurrently or sequentially two or more of said plurality of RNA or cDNA produced therefrom to thereby produce amplified fragments or amplified signals, wherein amplification is performed qualitatively or quantitatively using at least two primers or probes, each specific for RNA species comprising parts of a combination of RNA species indicative of a disease, or cDNA thereof;
• and
• c) qualitatively or quantitatively detecting at least two of the amplified fragments or amplified signals produced from the combination of RNA species or cDNAs prepared therefrom.