CANCER-RELATED BIOLOGICAL MATERIALS IN MICROVESICLES

1 . A method for assaying a biological sample from a subject in aid of diagnosis, prognosis or monitoring of a disease or other medical condition in the subject, comprising the steps of:

a. isolating a microvesicle fraction from a biological sample from a subject by filtering the sample followed by ultrafiltration concentration to produce a microvesicle fraction;

b. extracting nucleic acid from the fraction; and

c. detecting the presence or absence of a biomarker in the extracted nucleic acid;

wherein the biomarker is (i) a genetic aberration associated with diagnosis, prognosis, status or stage of a disease or other medical condition, (ii) a genetic aberration associated with a disease or other medical condition or with responsiveness to a specific therapy for the disease or other medical condition, or (iii) a genetic aberration associated with a determination of the subject's risk of developing a disease or other medical condition, and wherein the genetic aberration is in or corresponds to:

i. a c-myc gene;

ii. a transposable element;

iii. a retrotransposon element;

iv. a satellite correlated gene;

v. a repeated DNA element;

vi. non-coding RNA other than miRNA; or

vii. a fragment of any of the foregoing.

2 . The method of claim 1 , wherein the genetic aberration is in or corresponds to an element selected from the group consisting of: a transposable element listed in Table 4 or Table 5, or a fragment thereof; a retrotransposon element that is LINE, SINE or HERV, or a fragment thereof, a retrotransposon element that is Line1 (L1), ALU, HERV-H, HERV-K, HERV-K6, HERV-W or HERV-C, or a fragment thereof, a satellite correlated gene listed in Table 6, or a fragment thereof, a repeated DNA element listed in Table 8, or a fragment thereof; and a non-coding RNA listed in Table 9 (or a fragment thereof), other than miRNA.

3 - 27 . (canceled)

28 . A method for assaying a biological sample from a subject in aid of diagnosis, prognosis or monitoring of a disease or other medical condition in the subject, comprising the steps of:

a. isolating a microvesicle fraction from a biological sample from a subject by filtering the sample followed by ultrafiltration concentration to produce a microvesicle fraction;

b. measuring a polypeptide activity in the fraction; and

c. determining whether the polypeptide activity is higher or lower than a normal or average activity for the polypeptide;

wherein an elevated or lowered activity is associated with diagnosis, prognosis, status or stage of a disease or other medical condition.

29 . The method of claim 28 , wherein the polypeptide is an enzyme.

30 . The method of claim 29 , wherein the enzyme is reverse transcriptase.

31 . The method of claim 30 , wherein step (c) involves determining whether the reverse transcriptase activity is higher than a normal or average activity for reverse transcriptase.

32 - 39 . (canceled)

40 . The method of claim 1 , wherein the genetic aberration is:

a. a species of nucleic acid;

b. the level of expression of a nucleic acid;

c. a nucleic acid variant; or

d. a combination of any of the foregoing.

41 . The method of claim 1 , wherein the nucleic acid is RNA and the genetic aberration is an expression profile.

42 . The method of claim 1 , wherein the fragment contains more than 10 nucleotides.

43 . The method of claim 1 , wherein the biological sample is a bodily fluid.

44 . The method of claim 43 , wherein the bodily fluid is blood, serum, plasma, or urine.

45 . The method of claim 1 , wherein the subject is a human subject.

46 . The method of claim 1 , wherein the disease or other medical condition is brain cancer.

47 . The method of claim 46 , wherein the brain cancer is medulloblastoma or glioblastoma.

48 . The method of claim 1 , wherein the disease or other medical condition is melanoma.

49 . The method of claim 1 , wherein the step of detecting the presence or absence of a biomarker in the extracted nucleic acid comprises microarray analysis, PCR, quantitative PCR, Digital Gene Expression, or direct sequencing.

50 . The method of claim 1 , further comprising the step of enriching the microvesicle fraction for microvesicles originating from a specific cell type.

51 - 62 . (canceled)

63 . A method of treating a subject having a form of cancer in which cancer cells secrete microvesicles, the method comprising administering to the subject a therapeutically effective amount of a composition comprising:

a. an inhibitor of microvesicle secretion;

b. an inhibitor of a reverse transcriptase;

c. a microvesicle neutralizer that neutralizes the pro-tumor progression activity of tumor microvesicles; or

d. any combination of the forgoing.

64 . The method of claim 63 , wherein the inhibitor of microvesicle secretion is an inhibitor of RAB GTPase.

65 . The method of claim 64 , where in the Rab GTPase is Rab 27a, Rab 27b or Rab 35.

66 . The method of claim 63 , wherein the inhibitor of a reverse transcriptase is a nucleoside analog selected from the group comprising 3′-azido2′,3′-dideoxythymidine (AZT), 2′,3′-dideoxyinosine (ddI), 2′,3′-didehyro-3′-deoxythymidine (d4T), nevirapine and efavirenz.

67 . The method of claim 63 , wherein the inhibitor of a reverse transcriptase is RNAi targeting the reverse transcriptase gene.

68 . The method of claim 63 , wherein the microvesicle neutralizer is a biological agent that binds microvesicles and destroys the integrity of the microvesicles.

69 . (canceled)

70 . The method of claim 28 , wherein the biological sample is a bodily fluid.

71 . The method of claim 70 , wherein the bodily fluid is blood, serum, plasma, or urine.

72 . The method of claim 28 , wherein the subject is a human subject.

73 . The method of claim 28 , wherein the disease or other medical condition is brain cancer.

74 . The method of claim 28 , wherein the brain cancer is medulloblastoma or glioblastoma.

75 . The method of claim 28 , wherein the disease or other medical condition is melanoma.

76 . The method of claim 28 , further comprising the step of enriching the microvesicle fraction for microvesicles originating from a specific cell type.