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AssigneeThe Penn State Research Foundation
InventorsChristopher D. Gocke, Michael S. Kopreski, Floyd A. Benko
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This invention relates to detection of specific extracellular nucleic acid in plasma or serum fractions of human or animal blood associated with neoplastic or proliferative disease. Specifically, the invention relates to detection of nucleic acid derived from mutant oncogenes or other tumor-associated DNA, and to those methods of detecting and monitoring extracellular mutant oncogenes or tumor-associated DNA found in the plasma or serum fraction of blood by using rapid DNA extraction followed by nucleic acid amplification with or without enrichment for mutant DNA. In particular, the invention relates to the detection, identification, or monitoring of the existence, progression or clinical status of benign, premalignant, or malignant neoplasms in humans or other animals that contain a mutation that is associated with the neoplasm through detection of the mutated nucleic acid of the neoplasm in plasma or serum fractions. The invention permits the detection of extracellular, tumor-associated nucleic acid in the serum or plasma of humans or other animals recognized as having a neoplastic or proliferative disease or in individuals without any prior history or diagnosis of neoplastic or proliferative disease. The invention provides the ability to detect extracellular nucleic acid derived from genetic sequences known to be associated with neoplasia, such as oncogenes, as well as genetic sequences previously unrecognized as being associated with neoplastic or proliferative disease. The invention thereby provides methods for early identification of colorectal, pancreatic, lung, breast, bladder, ovarian, lymphoma and all other malignancies carrying tumor-related mutations of DNA and methods for monitoring cancer and other neoplastic disorders in humans and other animals.
A method for detecting non-mutated tumor-associated DNA in blood plasma or serum from a human or animal with cancer, wherein said DNA is characterized by a non-mutated DNA alteration associated with cancer, the method comprising the steps of:
A method of identifying, diagnosing, monitoring, or evaluating cancer in a human or animal by detecting an altered non-mutated DNA associated with cancer in blood plasma or serum from the human or animal, the method comprising the steps of:
A method for detecting a translocated tumor-associated extracellular DNA in blood plasma or serum of a human or animal with cancer, the method comprising the steps of:
A method of identifying, diagnosing, monitoring, or evaluating cancer in a human or animal, wherein extracellular DNA comprising a translocated DNA associated with cancer is detected in blood plasma or serum from the human or animal, the method comprising the steps of:
A method for selecting a human for colonoscopy, the method comprising the steps of obtaining blood plasma or serum from the human and assaying the plasma or serum for the presence of extracellular, non-mutated tumor-associated DNA, wherein said DNA is characterized by a non-mutated DNA alteration associated with cancer, and selecting the human for colonoscopy when the presence of non-mutated tumor-associated DNA is detected.
A method for selecting a human for endoscopy, the method comprising the steps of obtaining blood plasma or serum from the human and assaying the plasma or serum for the presence of extracellular, non-mutated tumor-associated DNA, wherein said DNA is characterized by a non-mutated DNA alteration associated with cancer, and selecting the human for endoscopy when the presence of non-mutated tumor-associated DNA is detected.
A method for selecting a human for bronchoscopy, the method comprising the steps of obtaining blood plasma or serum from the human and assaying the plasma or serum for the presence of extracellular, non-mutated tumor-associated DNA, wherein said DNA is characterized by a non-mutated DNA alteration associated with cancer, and selecting the human for bronchoscopy when the presence of non-mutated tumor-associated DNA is detected.
A method for selecting a human for radiologic imaging, the method comprising the steps of obtaining blood plasma or serum from the human and assaying the plasma or serum for the presence of extracellular, non-mutated tumor-associated DNA, wherein said DNA is characterized by a non-mutated DNA alteration associated with cancer, and selecting the human for radiologic imaging when the presence of non-mutated tumor-associated DNA is detected.
A method for detecting extracellular nucleic acid encoding all or a portion of bcl-2 in blood plasma or serum of a human or animal with cancer, the method comprising the steps of:
A method for identifying, diagnosing, monitoring, or evaluating cancer in a human or animal by detecting extracellular nucleic acid encoding all or a portion of bcl-2 in blood plasma or serum from the human or animal with cancer, the method comprising the steps of:
A method for identifying, diagnosing, monitoring, or evaluating cancer in a human or animal, wherein one or more tumor-associated DNA species are detected in blood extracellular DNA from blood plasma or serum from the human or animal, wherein at least one of said DNA species is a non-mutated DNA characterized by a non-mutated DNA alteration associated with cancer, the method comprising the steps of:
A method for identifying, diagnosing, monitoring, or evaluating cancer in a human or animal, wherein one or more tumor-associated DNA species are detected in extracellular DNA from blood plasma or serum from the human or animal, wherein at least one of said DNA species is a translocated DNA, the method comprising the steps of:
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