IP Library › Granted Patent US 12,290,765
Granted Patent B2
US 12,290,765 · App. 18/582,572 · Granted May 6, 2025

Materials and methods for processing blood samples

Inventor: Aoy Tomita Mitchell (Elm Grove, WI)
Assignee: Natera, Inc.
B01D21/262B01L3/5082B04B5/0414
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Quick Facts
Patent No.
US 12,290,765
App. No.
18/582,572
Granted
May 6, 2025
Kind
B2
Abstract

Provided herein are materials and methods relating to cell-free DNA. In particular, the technology relates to methods and materials for the preparation and handling of blood samples for future use in applications involving cell-free DNA.

Claims (23)

1. A method for quantifying cell-free DNA, the method comprising:

(a) providing a tube comprising

an outer wall and a base defining an internal volume for containing a blood sample;

a chemical preservative disposed in the internal volume, wherein the chemical preservative comprises one or more of metaformaldehyde, paraformaldehyde, poloxamer, glycerol, propranolol, dex-propranolol, methacrylate monomer, methacrylate polymer, or bis-dienoyl phosphatidylcholine;

a physical separator disposed in the internal volume, wherein the physical separator substantially separates the blood sample into at least a plasma component and a blood cell component when the tube is centrifuged and prevents aspiration of the blood cell component during subsequent isolation of the plasma component from the tube; and

a blood sample disposed in the tube;

(b) centrifuging the tube at a first fixed speed to separate the blood sample into at least a plasma component and a blood cell component;

(c) isolating the plasma component;

(d) centrifuging the isolated plasma component at a second fixed speed to obtain a purified plasma component, wherein the first fixed speed and the second fixed speed are each independently selected from a speed ranging from 500×g to 2000×g; and

(e) quantifying cell-free DNA present in the further purified plasma component.

2. The method of claim 1 , further comprising isolating the further purified plasma component after step (d).

3. The method of claim 2 , further comprising storing the isolated further purified plasma component at a temperature of −20° C. or colder.

4. The method of claim 2 , comprising determining an amount of cf-DNA in the further purified isolated plasma component.

5. The method of claim 1 , wherein the blood cell component includes a white blood cell component and a red blood cell component.

6. The method of claim 5 , further comprising isolating the white blood cell component after step (b).

7. The method of claim 6 , wherein the method further comprises storing the isolated white blood cell component at a temperature of −20° C. or colder.

8. The method of claim 1 , wherein the first fixed speed and the second fixed speed are the same.

9. The method of claim 8 , wherein the first fixed speed and the second fixed speed are each 1100×g.

10. The method of claim 8 , wherein the first fixed speed and the second fixed speed are each 1400×g.

11. The method of claim 1 , wherein step (e) comprises quantifying cell-free DNA comprising at least one mutation.

12. The method of claim 1 , wherein step (e) comprises quantifying cell-free DNA derived from a transplant.

13. The method of claim 1 , wherein step (e) comprises quantifying cell-free DNA derived from a cancer.

14. The method of claim 1 , wherein step (e) comprises quantifying cell-free DNA derived from a fetus.

Continuity (3)
Continuation 16839319 · Apr 3, 2020
Provisional Application 62829320 · Apr 4, 2019
Related Publication 20240350945A1 · Oct 24, 2024
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