IP Library › Patent Application 17374917
Patent Application
App. No. 17/374,917

COMPOSITIONS AND METHODS FOR ACCURATELY IDENTIFYING MUTATIONS

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Patent No.
US None
App. No.
17/374,917
Abstract

The present disclosure provides compositions and methods for accurately detecting mutations by uniquely tagging double stranded nucleic acid molecules with dual cyphers such that sequence data obtained from a sense strand can be linked to sequence data obtained from an anti-sense strand when sequenced, for example, by massively parallel sequencing methods.

Claims (39)

1 .- 38 . (canceled)

39 . A method for detecting mutations from exposure to a substance, the method comprising:

(a) preparing a sequencing library from a sample comprising a plurality of double-stranded DNA molecules from a patient exposed to the substance, wherein preparing the sequencing library comprises ligating cypher polynucleotides to the double-stranded DNA molecules to form double-stranded cypher-target nucleic acid complexes, wherein the cypher polynucleotides comprise identifier tags selected from a plurality of distinct identifier tag sequences;

(b) sequencing first and second strands of the cypher-target nucleic acid complexes to produce a plurality of first-strand sequencing reads and a plurality of second-strand sequencing reads;

(c) for each cypher-target nucleic acid complex among a plurality of the cypher-target nucleic acid complexes, comparing the first-strand sequencing reads with the second-strand sequencing reads to identify nucleotides in the first strand that have a corresponding complementary nucleotide in the second strand;

(d) detecting a mutation from exposure to the substance by analyzing an error-corrected sequence generated from the first strand sequencing reads and second strand sequencing reads for each of the cypher-target nucleic acid complexes among a plurality of the cypher-target nucleic acid complexes; and comparing the error-corrected sequences to a reference sequence to identify one or more of a mutation, a genomic distribution of mutations, a mutation frequency, sequence heterogeneity, or DNA damage.

40 . The method of claim 39 , wherein the sample is derived from a human.

41 . The method of claim 39 , wherein prior to preparing the sequencing library, the method further comprises exposing the patient to the substance.

42 . The method of claim 41 , wherein prior to exposing the patient to the substance, the patient comprises a normal tissue.

43 . The method of claim 39 , wherein the sample comprises a blood sample.

44 . The method of claim 39 , wherein the identifier tag sequences comprise random or partially random sequences.

45 . The method of claim 44 , wherein the random or partially random sequences comprise a length from about 5 nucleotides to about 10 nucleotides.

46 . The method of claim 44 , wherein the identifier tags are double-stranded sequences.

47 . The method of claim 39 , further comprising purifying a plurality of cypher-target nucleic acid complexes prior to sequencing, wherein the purified cypher-target nucleic acid complexes comprise nucleic acid molecules from specific genomic regions.

48 . The method of claim 39 , wherein prior to sequencing, the method further comprises amplifying each strand of the cypher-target nucleic acid complexes to produce a set of copies of original first strands of the cypher-target nucleic acid complexes and a set of copies of complementary original second strands of the cypher-target nucleic acid complexes.

49 . The method of claim 39 , wherein prior to comparing the first-strand sequencing reads with the second-strand sequencing reads, the method comprises grouping sequencing reads based on (i) the identifier tag sequences and (ii) sequence information from the double-stranded DNA molecules.

50 . The method of claim 39 , wherein each of the error-corrected sequences has only nucleotide bases at which the majority of first strand sequencing reads and second strand sequencing reads are in agreement.

51 . The method of claim 50 , wherein the method comprises calculating a mutation frequency among the plurality of double-stranded DNA molecules.

52 . The method of claim 51 , wherein the mutations are transition mutations.

53 . The method of claim 50 , wherein a sequence difference between the error-corrected sequence and the reference sequence is identified as a true mutation.

54 . The method of claim 53 , wherein the true mutation is a substitution or insertion mutation type.

55 . The method of claim 53 , wherein the true mutation is a transition mutation.

56 . The method of claim 50 , wherein the error-corrected sequences map to the reference sequence, and the method further comprises identifying a distribution of mutations in the double-stranded DNA molecules.

57 . The method of claim 54 , wherein the error-corrected sequences map to the reference sequence, and the method further comprises identifying a distribution of mutation types in the double-stranded DNA molecules.

58 . The method of claim 39 , wherein the error corrected sequence is generated by distinguishing erroneous nucleotides in one strand that lack a matched base change in the complementary strand, and wherein the erroneous nucleotides are the result of systematic or biological errors in one strand.

59 . The method of claim 39 , wherein the method comprises determining a genomic distribution of mutations with respect to the reference sequence.

60 . A method of identifying effects of DNA damaging compounds, the method comprising:

(a) providing a sample comprising a plurality of double-stranded DNA molecules from a patient that has been treated with a compound;

(b) preparing a sequencing library from the sample by ligating cypher polynucleotides to the double-stranded DNA molecules to form double-stranded cypher-target nucleic acid complexes, wherein the cypher polynucleotides comprise identifier tags selected from a plurality of distinct identifier tag sequences;

(c) for each cypher-target nucleic acid complex among a plurality of the cypher-target nucleic acid complexes, generating a set of copies of a first strand of the cypher-target nucleic acid complex and a set of distinct yet related copies of a complementary second strand of the cypher-target nucleic acid complex;

(d) sequencing one or more copies of the first and complementary second strands to produce a plurality of first-strand sequencing reads and a plurality of distinct yet related second-strand sequencing reads;

(e) for each cypher-target nucleic acid complex among a plurality of the cypher-target nucleic acid complexes, comparing the first-strand sequencing reads with the second-strand sequencing reads to identify nucleotides in the first strand that have a corresponding complementary nucleotide in the second strand;

(f) comparing an error-corrected sequence generated from the first strand sequencing reads and second strand sequencing reads to a reference sequence to determine one or more of a mutation, a genomic distribution of mutations, a mutation frequency, sequence heterogeneity, or DNA damage; and

(g) based on the comparing step, identifying DNA damage from the compound.

61 . The method of claim 60 , wherein the error corrected sequence is generated by distinguishing erroneous nucleotides in one strand that lack a matched base change in the complementary strand, and wherein the erroneous nucleotides are the result of systematic or biological errors in one strand.

62 . The method of claim 60 , wherein step (a) further comprises providing a plurality of samples from a plurality of patients treated with the compound.

63 . The method of claim 60 , further comprising purifying a plurality of cypher-target nucleic acid complexes prior to sequencing, wherein the purified cypher-target nucleic acid complexes comprise nucleic acid molecules from specific genomic regions, and wherein the specific genomic regions comprise mutations common to most cells of a tumor.

64 . The method of claim 60 , wherein the double-stranded DNA molecules comprise a deaminated cytosine.

65 . The method of claim 64 , wherein the method further comprises enzymatically treating the double-stranded DNA molecules to repair damaged ends thereof prior to the ligating.

Assignments (2)
MERGER AND CHANGE OF NAME Recorded Jun 1, 2022
From: FRED HUTCHINSON CANCER RESEARCH CENTER; SEATTLE CANCER CARE ALLIANCE
To: FRED HUTCHINSON CANCER CENTER
Reel/Frame 060254/0115 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 27, 2022
From: BIELAS, JASON H.; BERTOUT, JESSICA A.
To: FRED HUTCHINSON CANCER RESEARCH CENTER
Reel/Frame 060042/0776 →