USE OF MICROVESICLES IN DIAGNOSIS AND PROGNOSIS OF MEDICAL DISEASES AND CONDITIONS
First Claim
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1. A diagnostic method, wherein said method aids in the detection of a non-infectious disease or condition in a subject, the method comprising the steps of:
- (a) isolating a microvesicle fraction from a biological sample from the subject;
(b) detecting the presence or absence of a nucleic acid biomarker within the microvesicle fraction, wherein the biomarker is associated with the disease or other medical condition.
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Abstract
The presently disclosed subject matter is directed to methods of aiding diagnosis, prognosis, monitoring and evaluation of a disease or other medical condition in a subject by detecting a biomarker in microvesicles isolated from a biological sample from the subject.
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Citations
69 Claims
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1. A diagnostic method, wherein said method aids in the detection of a non-infectious disease or condition in a subject, the method comprising the steps of:
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(a) isolating a microvesicle fraction from a biological sample from the subject; (b) detecting the presence or absence of a nucleic acid biomarker within the microvesicle fraction, wherein the biomarker is associated with the disease or other medical condition.
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2. A monitoring method, wherein said method aids in monitoring the status of a non-infectious disease or condition in a subject, the method comprising the steps of:
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(a) isolating a microvesicle fraction from a biological sample from the subject; (b) detecting the presence or absence of a nucleic acid biomarker within the microvesicle fraction, wherein the biomarker is associated with the disease or other medical condition.
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3. An evaluation method, wherein said method aids in evaluating treatment efficacy in a subject having a disease or other medical condition, the method comprising the steps of:
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(a) isolating a microvesicle fraction from a biological sample from the subject; (b) detecting the presence or absence of a nucleic acid biomarker within the microvesicle fraction, wherein the biomarker is associated with treatment efficacy for the disease or other medical condition.
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4. A diagnostic method, wherein said method aids in the detection of a disease or other medical condition in a subject, the method comprising the steps of:
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(a) obtaining a biological sample from the subject; and (b) determining the concentration of microvesicles within the biological sample.
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5. A monitoring method, wherein said method aids in monitoring the status of a disease or other medical condition in a subject, the method comprising the steps of:
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(a) obtaining a biological sample from the subject; and (b) determining the concentration of microvesicles within the biological sample.
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6. A method for delivering a nucleic acid or protein to a target cell in an individual comprising, administering one or more microvesicles that contain the nucleic acid or protein, or one or more cells that produce such microvesicles, to the individual such that the microvesicles enter the target cell of the individual.
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7. A method for performing a body fluid transfusion, comprising the steps of obtaining a fraction of donor body fluid free of all or substantially all microvesicles, or free of all or substantially all microvesicles from a particular cell type, and introducing the microvesicle-free fraction to a patient.
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8. A composition of matter comprising a sample of body fluid free of all or substantially all microvesicles, or free of all or substantially all microvesicles from a particular cell type.
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9. A method for performing body fluid transfusion, comprising the steps of obtaining a microvesicle-enriched fraction of donor body fluid and introducing the microvesicle-enriched fraction to a patient.
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10. A method for diagnosing a cancer in a subject, comprising:
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(a) providing a biological sample from a subject; (b) isolating cancer-derived exosomes comprising microRNAs (mi RNAs) from the biological sample; (c) determining an amount of one or more of the miRNAs; and (d) comparing the amount of the one or more miRNAs to one or more miRNA control levels, wherein the subject is diagnosed as having the cancer if there is a measurable difference in the amount of the one or more miRNAs from the cancer-derived exosomes as compared to the one or more miRNA control levels. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 66)
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24. A method for diagnosing a cancer in a subject, comprising:
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(a) isolating exosomes from a biological sample from a subject, wherein the exosomes originate from cancer cells and comprise microRNAs (miRNAs); (b) determining the amount of one or more miRNAs specific to a cancer, wherein an increase or decrease in the amount of miRNA specific to a cancer is indicative of cancer in the subject.
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25. A method for diagnosing a cancer in a subject, comprising:
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(a) isolating cancer-derived exosomes from a biological sample from a subject, wherein the exosomes comprise miRNAs; (b) analyzing the miRNAs for an increase or decrease in levels of miRNAs specific to the cancer; wherein the presence of an increase or decrease is indicative of cancer in the subject.
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26. A method for monitoring progression or regression of a cancer in a subject periodically over time, comprising:
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(a) providing a series of biological samples from a subject; (b) periodically isolating cancer-derived exosomes comprising microRNAs (mi RNAs) from the biological samples; (c) determining an amount of one or more of the miRNAs for each sample; and (d) determining any measurable difference in the amount of the one or more miRNAs from the cancer-derived exosomes from the series to thereby monitor progression or regression of the cancer in the subject. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 67)
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39. A method for monitoring progression or regression of a cancer in a subject, comprising:
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(a) periodically isolating exosomes from a biological sample from a subject, wherein the exosomes originate from cancer cells and comprise microRNAs (miRNAs); (b) determining the amount of one or more miRNAs specific to a cancer for each period; wherein an increase or decrease in the amount of miRNA specific to a cancer at each period is indicative of progression or regression of cancer in the subject.
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40. A method for monitoring progression or regression of a cancer in a subject, comprising:
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(a) periodically isolating cancer-derived exosomes from a biological sample from a subject wherein the exosomes comprise miRNAs; (b) analyzing the miRNAs for an increase or decrease in levels of miRNAs specific to the cancer for each period; wherein the presence of an increase or decrease at each period is indicative of progression or regression of cancer in the subject.
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41. A method for profiling a cancer in a subject, comprising:
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(a) providing a biological sample from a subject; (b) isolating cancer-derived exosomes comprising microRNAs (mi RNAs) from the biological sample; (c) determining an amount of one or more of the miRNAs; and (d) comparing the amount of the one or more miRNAs to one or more miRNA control levels, wherein the cancer is profiled based on a measurable difference in the amount of the one or more miRNAs from the cancer-derived exosomes as compared to the one or more miRNA control levels. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 68)
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55. A method for identifying a genetic basis that influences treatment effecting a cancer in a subject, comprising:
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(a) providing a biological sample from a subject; (b) isolating cancer-derived exosomes comprising microRNAs (mi RNAs) from the biological sample; (c) determining an amount of one or more of the miRNAs; and (d) comparing the amount of the one or more miRNAs to one or more miRNA control levels, wherein the genetic basis that influences treatment effecting a cancer in a subject is identified based on a measurable difference in the amount of the one or more miRNAs from the cancer-derived exosomes as compared to the one or more miRNA control levels. - View Dependent Claims (69)
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56. A method for profiling a cancer in a subject, comprising:
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(a) isolating exosomes originating from a cancer comprising microRNAs (miRNAs) from a biological sample from a subject; (b) determining the amount of one or more miRNAs specific to a cancer; wherein the cancer is profiled based on the presence of an increase or decrease in the amount of miRNA specific to the cancer.
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57. A method for identifying a genetic basis that influences treatment effecting a cancer in a subject, comprising:
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(a) isolating exosomes originating from cancer comprising microRNAs (miRNAs) from a biological sample from a subject; (b) determining the amount of one or more miRNAs specific to a cancer; wherein an increase or decrease in the amount of miRNA specific to a cancer is indicative of a genetic basis that influences treatment effecting the cancer in the subject.
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58. A method for profiling a cancer in a subject, comprising:
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(a) isolating cancer-derived exosomes comprising miRNAs from a biological sample from a subject (b) analyzing the miRNAs for an increase or decrease in levels of miRNAs specific to the cancer; wherein the cancer is profiled based on the presence of an increase or decrease in levels of miRNAs specific to the cancer.
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59. A method for identifying a genetic basis that influences treatment effecting a cancer in a subject, comprising:
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(a) isolating cancer-derived exosomes comprising miRNAs from a biological sample from a subject; (b) analyzing the miRNAs for an increase or decrease in levels of miRNAs specific to the cancer; wherein the presence of an increase or decrease is indicative of a genetic basis that influences treatment effecting the cancer in the subject.
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60. A method of diagnosing prenatal disease or medical condition, comprising:
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(a) providing a biological sample from a subject; (b) isolating exosomes comprising microRNAs (mi RNAs) from the biological sample; (c) determining an amount of one or more of the miRNAs; and (d) comparing the amount of the one or more miRNAs to one or more miRNA control levels, wherein the subject is diagnosed with the prenatal disease or medical condition if there is a measurable difference in the amount of the one or more miRNAs from the exosomes as compared to the one or more miRNA control levels. - View Dependent Claims (61, 62, 63, 64, 65)
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Specification