IP Library Patent Application 18353647
Patent Application
App. No. 18/353,647

COMPOSITIONS AND METHODS FOR CHARACTERIZING ZDHHC1 DNA

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Patent No.
US None
App. No.
18/353,647
Abstract

Provided herein is technology relating compositions and methods for detecting tissue cell-specific DNA, such as epithelial cell-specific DNA, in blood or blood products from a subject. The technology also relates to use of tissue cell-specific DNAs as internal controls for methylation assays.

Claims (27)

1 - 30 . (canceled)

31 . A method of producing an amplified product from a stool sample from a human subject, the method comprising:

a) in a clarified stool supernatant sample, forming a complex comprising:

i) a target sequence-specific capture reagent comprising a particle covalently attached to a target-specific capture probe oligonucleotide complementary to methylated human ZDHHC1 DNA at a site within SEQ ID NO:26 or its complement, and

ii) a strand of methylated ZDHHC1 DNA comprising SEQ ID NO:26 or its complement from a sample from a human subject, wherein cytosine-phosphate-guanine (CpG) dinucleotides in the methylated ZDHHC1 DNA are methylated;

wherein the target-specific capture probe oligonucleotide is specifically hybridized to the strand of methylated ZDHHC1 DNA at a site within SEQ ID NO:26 or its complement;

b) separating the complex from the clarified stool supernatant sample to form a separated sample comprising the strand of methylated ZDHHC1 DNA; and

c) amplifying a region of ZDHHC1 DNA from the separated sample using a pair of primers that hybridize within a region of ZDHHC1 DNA corresponding to SEQ ID NO: 26 or its complement and that are extended by a DNA polymerase to produce an amplified product.

32 . The method of claim 31 , further comprising detecting the amplified product.

33 . The method of claim 32 , wherein detecting the amplified product comprises a quantitative amplification reaction.

34 . The method of claim 33 , wherein the quantitative amplification reaction comprises real-time fluorescence detection.

35 . The method of claim 33 , wherein detecting the amplified product comprises detecting hybridization of amplified product to a detection probe.

36 . The method of claim 35 , wherein the detection probe comprises a flap sequence.

37 . The method of claim 35 , wherein the detection probe comprises a reporter molecule.

38 . The method of claim 37 , where the reporter molecule comprises a fluorophore.

39 . The method of claim 35 , wherein detecting hybridization of the amplified product to the detection probe comprises use of a FEN-1 endonuclease.

40 . The method of claim 35 , wherein detecting hybridization of the amplified product to the detection probe comprises use of a FRET cassette.

41 . The method of claim 33 , wherein detecting the amplified product comprises using one or more of nucleic acid sequencing and mass-based separation.

42 . The method of claim 31 , further comprising prior to step c) a step of treating DNA from separated sample with bisulfite, wherein treatment with bisulfite converts un-methylated dC bases in the DNA from the separated sample to dU bases.

43 . The method of claim 31 , wherein the particle is a magnetic particle.

44 . The method of claim 31 , wherein the target-specific capture probe oligonucleotide has a complete length of between 15 and 100 nucleotides.

45 . The method of claim 44 , wherein the complete length of the target-specific capture probe oligonucleotide is hybridized to the methylated ZDHHC1 DNA within SEQ ID NO:26.

46 . The method of claim 31 , wherein the target-specific capture probe oligonucleotide is covalently attached to the particle by a non-nucleic acid chemical linkage.

47 . The method of claim 46 wherein the non-nucleic acid chemical linkage comprises a multi-carbon chain.

48 . The method of claim 47 , wherein the multi-carbon chain is attached to a 5′ nucleotide of the target-specific capture probe oligonucleotide.

49 . The method of claim 31 , wherein the clarified stool supernatant sample comprises guanidine thiocyanate.

50 . The method of claim 31 , wherein the clarified stool supernatant sample is pretreated to remove assay inhibitors.

Assignments (3)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT RIGHTS (REEL/FRAME 69898/0249) Recorded Mar 27, 2026
From: JPMORGAN CHASE BANK, N.A.
To: EXACT SCIENCES CORPORATION
Reel/Frame 075288/0393 →
PATENT SECURITY AGREEMENT Recorded Jan 14, 2025
From: EXACT SCIENCES CORPORATION
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 069898/0249 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 2, 2023
From: ALLAWI, HATIM T; LIDGARD, GRAHAM P
To: EXACT SCIENCES CORPORATION
Reel/Frame 065100/0415 →