Detection of extracellular tumor-associated nucleic acid in blood plasma or serum using nucleic acid amplification assays

A method for detecting a plurality of tumor-associated DNA that code for genes or fragments thereof in blood plasma or serum from a human or animal with cancer, wherein at least one of said genes is not a mutated oncogene or a mutated tumor suppressor gene, the method comprising the steps of:

• a) extracting DNA from blood plasma or serum from a human or animal;
• b) amplifying or signal amplifying serially or in a multiplexed fashion a portion of the extracted DNA, wherein said portion comprises tumor-associated DNA, whereby at least one amplified DNA is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene;
• and
• c) detecting the amplified or signal amplified products.

A method for identifying, diagnosing, evaluating, or monitoring a gene or a fragment thereof in the blood plasma or serum from the human or animal, wherein said gene is not a mutated oncogene or a mutated tumor suppressor gene, the method comprising the steps of:

• a) extracting DNA from blood plasma or serum from a human or animal;
• b) amplifying or signal amplifying in a quantitative or qualitative manner a portion of the extracted DNA, wherein the portion comprises extracted tumor-associated DNA that codes for a gene or a fragment thereof, wherein said gene is not a mutated oncogene or a mutated tumor suppressor gene;
• c) quantitatively or qualitatively detecting the amplified or signal amplified product;
• and
• d) identifying, evaluating, or monitoring the human or animal with cancer thereby.

A method for identifying, diagnosing, evaluating, or monitoring a human or animal with cancer by detecting tumor-associated DNA that codes for a gene or a fragment thereof in blood plasma or serum from a human or animal, wherein said gene is not a mutated oncogene or a mutated tumor suppressor gene, the method comprising the steps of:

• a) extracting DNA from blood plasma, or serum obtained from the human or animal;
• b) performing DNA signal amplification on a portion of the extracted DNA using a DNA probe that hybridizes to a portion of the extracted tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene;
• c) detecting in a qualitative or quantitative manner hybridization of the extracted tumor-associated DNA with the DNA probe;
• and
• d) identifying, evaluating, or monitoring the human or animal having a cancer thereby.

A method for identifying a human or animal with cancer as a candidate for a therapy, wherein the method comprises the steps of:

• a) extracting DNA from blood plasma or serum obtained from a human or animal;
• b) specifically amplifying or signal amplifying a portion of the extracted DNA, wherein said DNA is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene, thereby producing an amplified DNA product;
• c) detecting the amplified product;
• d) identifying the human or animal as a candidate for the therapy thereby.

A method of detecting a plurality of DNA species or fragments thereof in plasma or serum from a human or animal with cancer, wherein at least one DNA species or fragment thereof is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene, the method comprising the steps of:

• a) extracting DNA from plasma or serum of a human or animal with cancer, wherein said extracted DNA comprises a plurality of DNA species or fragments thereof and wherein at least one DNA species is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene;
• b) amplifying or signal amplifying concurrently or sequentially at least two of said plurality of extracted DNA, wherein at least one DNA is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene, to produce amplified products or amplified signals, wherein amplification is performed qualitatively or quantitatively using at least two primers or probes, each specific for a DNA species, and
• c) detecting the amplified products or amplified signals produced from at least two of the amplified DNA species, wherein at least one of the detected amplified or signal amplified DNA species is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene.

A method for detecting a combination of DNA species in plasma or serum from a human or animal, wherein at least one DNA species in the combination is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene, wherein detection of said combination indicates a cancer in the human or animal, the method comprising the steps of:

• a) extracting DNA from plasma or serum from a human or animal, wherein said extracted DNA comprises a plurality of DNA species of which at least one is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene;
• b) amplifying or signal amplifying concurrently or sequentially two or more of said plurality of extracted DNA, wherein at least one of said DNA is a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene, to thereby produce amplified products or amplified signals, wherein amplification is performed qualitatively or quantitatively using at least two primers or probes, each specific for the DNA species comprising parts of a combination of DNA species indicative of a cancer;
• and
• c) qualitatively or quantitatively detecting at least two of the amplified products or amplified signals produced, wherein at least one detected amplified product or amplified signal is from a tumor-associated DNA that codes for a gene or a fragment thereof that is not a mutated oncogene or a mutated tumor suppressor gene.