IP Library Patent Application 13407886
Patent Application
App. No. 13/407,886

Methods for Diagnosing Breast Cancer Using MicroRNA Signatures

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Patent No.
US None
App. No.
13/407,886
Abstract

The present invention provides novel methods and compositions for the diagnosis and treatment of solid cancers. The invention also provides methods of identifying inhibitors of tumorigenesis.

Claims (43)

1 - 33 . (canceled)

34 . A method of diagnosing whether a subject has, or is at risk for developing, breast cancer, comprising:

a.) comparing the level of at least miR-146 gene product and at least one additional miR gene product in a test sample from a subject to a control level of at least one corresponding miR-146 gene product and at least one additional miR gene product; and

b.) diagnosing whether the subject has, or is at risk for developing, breast cancer, if the level of the at least one miR-146 gene product and at least one additional miR gene product in the test sample from the subject is greater than a control level of the corresponding miR-146 gene product and at least one additional miR gene product.

35 . A method of claim 34 , wherein the at least one additional miR gene product is miR-21.

36 . A method of claim 34 , wherein the at least one additional miR gene product is miR-29b-2.

37 . A method of claim 34 , wherein the at least one additional miR gene product is miR-181a.

38 . A method of claim 34 , which further comprises: comparing the level of at least one additional miR gene product in a test sample from the subject to a control level of the miR gene product, wherein the at least one additional miR gene product is selected from the group consisting of: miR-21; miR-29b-2; miR-146; miR-125b-2; miR-125b-1; miR-10b; miR-145; miR-181a; miR-140; miR-213; miR-29a prec; miR-181b-1; miR-199b; miR-29b-1; miR-130a; miR-155; let-7a-2; miR-205; miR-29c; miR-224; miR-100; miR-31; miR-30c; miR-17-5p; miR-210; miR-122a; and miR-16-2.

39 . A method of diagnosing whether a subject has, or is at risk for developing, breast cancer, comprising:

a.) comparing the level of at least miR-29b-2 gene product and at least one additional miR gene product in a test sample from a subject to a control level of at least one corresponding miR-29b-2 gene product and at least one additional miR gene product; and

b.) diagnosing whether the subject has, or is at risk for developing, breast cancer, if the level of the at least one miR-29b-2 gene product and at least one additional miR gene product in the test sample from the subject is greater than a control level of the corresponding miR-29b-2 gene product and at least one additional miR gene product.

40 . A method of claim 39 , wherein the at least one additional miR gene product is miR-21.

41 . A method of claim 39 , wherein the at least one additional miR gene product is miR-181a.

42 . A method of claim 39 , which further comprises: comparing the level of at least one additional miR gene product in a test sample from the subject to a control level of the miR gene product, wherein the at least one additional miR gene product is selected from the group consisting of: miR-21; miR-29b-2; miR-146; miR-125b-2; miR-125b-1; miR-10b; miR-145; miR-181a; miR-140; miR-213; miR-29a prec; miR-181b-1; miR-199b; miR-29b-1; miR-130a; miR-155; let-7a-2; miR-205; miR-29c; miR-224; miR-100; miR-31; miR-30c; miR-17-5p; miR-210; miR-122a; and miR-16-2.

43 . A method of diagnosing whether a subject has, or is at risk for developing, breast cancer, comprising:

a.) comparing the level of at least miR-21 gene product and at least one additional miR gene product in a test sample from a subject to a control level of at least one corresponding miR-21 gene product and at least one additional miR gene product; and

b.) diagnosing whether the subject has, or is at risk for developing, breast cancer, if the level of the at least one miR-21 gene product and at least one additional miR gene product in the test sample from the subject is greater than a control level of miR-21 gene product and less than a control level of at least one corresponding additional miR gene product.

44 . A method of claim 43 , wherein the at least one additional miR gene product is miR-125b-2.

45 . A method of claim 43 , wherein the at least one additional miR gene product is miR-125b-1.

46 . A method of claim 43 , wherein the at least one additional miR gene product is miR-10b.

47 . A method of claim 43 , wherein the at least one additional miR gene product is miR-145.

48 . A method of claim 43 , which further comprises: comparing the level of at least one additional miR gene product in a test sample from the subject to a control level of the miR gene product, wherein the at least one additional miR gene product is selected from the group consisting of: miR-21; miR-29b-2; miR-146; miR-125b-2; miR-125b-1; miR-10b; miR-145; miR-181a; miR-140; miR-213; miR-29a prec; miR-181b-1; miR-199b; miR-29b-1; miR-130a; miR-155; let-7a-2; miR-205; miR-29c; miR-224; miR-100; miR-31; miR-30c; miR-17-5p; miR-210; miR-122a; and miR-16-2.

49 . A method of diagnosing whether a subject has, or is at risk for developing, breast cancer, comprising:

a.) comparing the level of at least miR-29b-2 gene product and at least one additional miR gene product in a test sample from a subject to a control level of at least one corresponding miR-29b-2 gene product and at least one additional miR gene product; and

b.) diagnosing whether the subject has, or is at risk for developing, breast cancer, if the level of the at least one miR-29b-2 gene product and at least one additional miR gene product in the test sample from the subject is greater than a control level of miR-29b-2 gene product and less than a control level of at least one corresponding additional miR gene product.

50 . A method of claim 49 , wherein the at least one additional miR gene product is miR-125b-2.

51 . A method of claim 49 , wherein the at least one additional miR gene product is miR-125b-1.

52 . A method of claim 49 , wherein the at least one additional miR gene product is miR-10b.

53 . A method of claim 49 , wherein the at least one additional miR gene product is miR-145.

54 . A method of claim 49 , which further comprises: comparing the level of at least one additional miR gene product in a test sample from the subject to a control level of the miR gene product, wherein the at least one additional miR gene product is selected from the group consisting of: miR-21; miR-29b-2; miR-146; miR-125b-2; miR-125b-1; miR-10b; miR-145; miR-181a; miR-140; miR-213; miR-29a prec; miR-181b-1; miR-199b; miR-29b-1; miR-130a; miR-155; let-7a-2; miR-205; miR-29c; miR-224; miR-100; miR-31; miR-30c; miR-17-5p; miR-210; miR-122a; and miR-16-2.

55 . A method of diagnosing whether a subject has, or is at risk for developing, breast cancer, comprising:

a.) comparing the level of at least miR-146 gene product and at least one additional miR gene product in a test sample from a subject to a control level of at least one corresponding miR-146 gene product and at least one additional miR gene product; and

b.) diagnosing whether the subject has, or is at risk for developing, breast cancer, if the level of the at least one miR-146 gene product and at least one additional miR gene product in the test sample from the subject is greater than a control level of miR-146 gene product and less than a control level of at least one corresponding additional miR gene product.

56 . A method of claim 55 , wherein the at least one additional miR gene product is miR-125b-2.

57 . A method of claim 55 , wherein the at least one additional miR gene product is miR-125b-1.

58 . A method of claim 55 , wherein the at least one additional miR gene product is miR-10b.

59 . A method of claim 55 , wherein the at least one additional miR gene product is miR-145.

60 . A method of claim 55 , which further comprises: comparing the level of at least one additional miR gene product in a test sample from the subject to a control level of the miR gene product, wherein the at least one additional miR gene product is selected from the group consisting of: miR-21; miR-29b-2; miR-146; miR-125b-2; miR-125b-1; miR-10b; miR-145; miR-181a; miR-140; miR-213; miR-29a prec; miR-181b-1; miR-199b; miR-29b-1; miR-130a; miR-155; let-7a-2; miR-205; miR-29c; miR-224; miR-100; miR-31; miR-30c; miR-17-5p; miR-210; miR-122a; and miR-16-2.

61 . A method of diagnosing whether a subject has, or is at risk for developing, breast cancer, comprising:

a.) reverse transcribing at least two miR gene products from a test sample from the subject to provide at least two corresponding miR gene product target oligonucleotides;

b.) hybridizing at least two miR target oligodeoxynucleotides to a microarray comprising miRNA-specific probe oligonucleotides that include at least two corresponding miRNA-specific probe oligonucleotides to provide a hybridization profile for the test sample;

c.) comparing the test sample hybridization profile to a control hybridization profile for at least the two miR gene products; and

d.) diagnosing whether the subject has, or is at risk for developing, breast cancer if the level of at least two gene products in the test sample is greater than the control level of the two gene products, wherein the two miR gene products are gene products of the miRs selected from the group consisting of: miR-21; miR-29b-2; miR-146; miR-125b-2; miR-125b-1; miR-10b; miR-145; miR-181a; miR-140; miR-213; miR-29a prec; miR-181b-1; miR-199b; miR-29b-1; miR-130a; miR-155; let-7a-2; miR-205; miR-29c; miR-224; miR-100; miR-31; miR-30c; miR-17-5p; miR-210; miR-122a; and miR-16-2.

Assignments (3)
CONFIRMATORY LICENSE Recorded Aug 17, 2020
From: THE OHIO STATE UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH - DIRECTOR DEITR
Reel/Frame 053514/0228 →
CONFIRMATORY LICENSE Recorded Sep 24, 2015
From: OHIO STATE UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 036687/0121 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2012
From: CROCE, CARLO M.; CALIN, GEORGE A.; VOLINIA, STEFANO
To: THE OHIO STATE UNIVERSITY
Reel/Frame 027819/0315 →