Granted Patent
B2
US 12,188,080 · App. 18/303,536 · Granted Jan 7, 2025
Compositions and methods for isolation of cell-free DNA
Assignee:
Enumera Molecular, Inc.
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Abstract
Provided herein are compositions and methods for isolating cell-free nucleic acid, e.g., cell-free DNA, from a sample. In particular embodiments, provided herein are compositions and methods using anti-dsDNA antibodies for isolating cell-free DNA from a sample, and for providing a sample of isolated cell-free DNA, e.g., for a nucleic acid assay. In particular embodiments, the technology relates to providing cell-free DNA from a maternal sample that is enriched for fetal cell-free fetal DNA.
Claims (23)
1. A composition comprising a solution comprising:
a) antibody-DNA complexes that comprise:
i) cell-free DNA from a blood product sample from a human subject, and
ii) an exogenous anti-double-stranded DNA (anti-dsDNA) antibody that has reactivity to both single-stranded and double-stranded DNA.
2. The composition of claim 1 , wherein the human subject is a pregnant human subject, and wherein the cell-free DNA comprises cell-free fetal DNA.
3. The composition of claim 1 , wherein the human subject is suspected of having a tumor.
4. The composition of claim 1 , wherein the antibody-DNA complexes comprise cell-free DNA comprising a plurality of dsDNA fragments having lengths of between 50 and 200 bp and having a size distribution comprising peaks at about 143 bp and 166 bp.
5. The composition of claim 1 , wherein the solution comprises blood or a blood product from the human subject.
6. The composition of claim 5 , wherein the blood product comprises serum or plasma.
7. The composition of claim 1 , wherein the solution is substantially free of blood or blood product from the human subject such that any residual blood or blood product, if present, does not alter the function of the solution as compared to the solution if completely free of blood or blood product from the human subject.
8. The composition of claim 1 , wherein the solution further comprises one or more of:
b) a buffer;
c) a detergent;
d) a preservative;
e) a protease inhibitor; and
f) a nuclease inhibitor.
9. The composition of claim 1 , wherein the solution comprises a reaction mixture.
10. The composition of claim 9 , wherein the reaction mixture comprises at least one nucleic acid-modifying enzyme selected from a nucleic acid polymerase, a nuclease, and a ligase.
11. The composition of claim 1 , wherein the solution further comprises:
b) an antibody-binding reagent.
12. The composition of claim 11 , wherein the antibody-binding reagent comprises a protein selected from protein A, protein G, protein A/G, and protein L.
13. The composition of claim 12 , wherein the antibody-binding reagent comprises one or more beads.
14. The composition of claim 13 , wherein the one or more beads comprises one or more paramagnetic beads.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 19, 2023
From: PERRY, JEFFREY
To: PROGENITY, INC.
Reel/Frame 063703/0292 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 19, 2023
From: BIORA THERAPEUTICS, INC.
To: ENUMERA MOLECULAR, INC.
Reel/Frame 063703/0485 →
CHANGE OF NAME
Recorded May 19, 2023
From: PROGENITY, INC.
To: BIORA THERAPEUTICS, INC.
Reel/Frame 063708/0715 →
Continuity (4)
Continuation
PCTUS2021051355
· Sep 21, 2021
Provisional Application
63081308
· Sep 21, 2020
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