IP Library Granted Patent US 12,024,797
Granted Patent B2
US 12,024,797 · App. 17/133,418 · Granted Jul 2, 2024

Methods of preparing and analyzing cell-free nucleic acid sequencing libraries

Inventors: Matthew H. Larson (San Francisco, CA); Hyunsung John Kim (San Francisco, CA); Nick Eattock (Hercules, CA); Xiao Yang (San Francisco, CA)
Assignee: GRAIL, LLC
C40B50/06C12N15/1065C12N15/1093C12Q1/6806C12Q1/6855C12Q1/6874
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Quick Facts
Patent No.
US 12,024,797
App. No.
17/133,418
Granted
Jul 2, 2024
Kind
B2
Abstract

Aspects of the invention relate to methods for preparing and analyzing a sequencing library from a mixed cell-free DNA (cfDNA) sample, wherein the mixed sample includes double-stranded DNA (dsDNA), damaged dsDNA (e.g., nicked dsDNA), and single-stranded DNA (ssDNA) molecules. The subject methods facilitate the collection of information from dsDNA, ssDNA and damaged DNA (e.g., nicked DNA) molecules in a sample, thereby providing enhanced diagnostic information as compared to sequencing libraries that are prepared from dsDNA alone.

Claims (20)

1. A method for preparing a cell-free DNA (cfDNA) sequencing library from a cfDNA sample comprising a plurality of double-stranded DNA (dsDNA), nicked dsDNA, and single-stranded DNA (ssDNA) molecules, the method comprising:

extending, using a strand-displacing polymerase, a nicked dsDNA molecule to produce an ssDNA molecule;

ligating a universal adapter comprising a unique sequence tag to the ssDNA molecule;

extending the universal adapter to generate a nicked-ssDNA-derived dsDNA molecule; and

generating a cfDNA sequencing library from the nicked-ssDNA-derived dsDNA molecule.

2. The method according to claim 1 , further comprising ligating a sequencing Y-adapter to the nicked-ssDNA-derived dsDNA molecule before generating the cfDNA sequencing library.

3. The method according to claim 2 , wherein the sequencing Y-adapter comprises a unique sequence tag.

4. The method according to claim 1 , further comprising:

ligating a first sequencing Y-adapter to a first end of an intact dsDNA molecule in the cfDNA sample; and

ligating a second sequencing Y-adapter to a second end of the intact dsDNA molecule;

generating a cfDNA sequencing library from the intact dsDNA molecule.

5. The method according to claim 4 , wherein the first sequencing Y-adapter comprises a first unique sequence tag, and the second sequencing Y-adapter comprises a second unique sequence tag.

6. The method according to claim 5 , wherein the first and the second unique sequence tags are the same.

7. The method according to claim 5 , wherein the first and the second unique sequence tags are different.

8. The method according to claim 1 , wherein one or more of the unique sequence tags comprises a universal primer and at least one of a molecular barcode sequence, a unique molecular identifier (UMI), or an index sequence.

9. The method according to claim 1 , wherein one or more of the universal adapters comprises an adenylated 5′ end.

10. The method according to claim 1 , wherein one or more of the universal adapters comprises a blocked or a phosphorylated 3′ end.

11. The method according to claim 1 , further comprising performing an end repair reaction on a dsDNA molecule.

12. The method according to claim 1 , wherein generating the cfDNA sequencing library comprises performing a PCR amplification reaction.

13. The method according to claim 1 , wherein the cfDNA sample is isolated from a plasma fraction of a blood sample.

Assignments (2)
MERGER AND CHANGE OF NAME Recorded Oct 13, 2021
From: GRAIL, INC.; SDG OPS, LLC
To: GRAIL, LLC
Reel/Frame 057788/0719 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 27, 2021
From: LARSON, MATTHEW H.; KIM, HYUNSUNG JOHN; EATTOCK, NICK; YANG, XIAO
To: GRAIL, INC.
Reel/Frame 057615/0143 →
Continuity (5)
Division 16663147 · Oct 24, 2019
Division 15713296 · Sep 22, 2017
Provisional Application 62456029 · Feb 7, 2017
Provisional Application 62399167 · Sep 23, 2016
Related Publication 20210115512A1 · Apr 22, 2021