IP Library Granted Patent US 12,378,543
Granted Patent B2
US 12,378,543 · App. 16/756,803 · Granted Aug 5, 2025

Compositions for hemolysis and coagulation regulation and stabilization of extracellular vesicles

Inventors: Nicholas Michael George (Omaha, NE); Bradford A. Hunsley (Papillion, NE)
Assignee: STRECK LLC
C12N15/1003A01N1/124A01N1/126
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Quick Facts
Patent No.
US 12,378,543
App. No.
16/756,803
Granted
Aug 5, 2025
Kind
B2
Abstract

A composition and method of use thereof wherein the composition comprises one or more components capable of releasing an aldehyde, one or more anticoagulants or chelating agents, and one or more polysaccharides. The composition has a pH of from about 4 to about 6.

Claims (21)

1. A composition comprising:

(i) a component capable of releasing an aldehyde;

(ii) an anticoagulant comprising citric acid, trisodium citrate, and dextrose; and

(iii) α-cyclodextrin,

wherein the component capable of releasing an aldehyde is imidazolidinyl urea.

2. The composition of claim 1 , wherein the anticoagulant is anticoagulant citrate dextrose-A (ACD-A), anticoagulant citrate dextrose-B (ACD-B), or citrate-phosphate-dextrose-adenine (CPDA).

3. The composition of claim 1 , wherein the dextrose is present at a concentration of from about 2% to about 20% (weight/volume).

4. The composition of claim 3 , wherein citrate ion concentration is from about 200 mM to about 500 mM.

5. The composition of claim 1 , wherein the citric acid is present at a concentration of from about 0.5% to about 4% (weight/volume).

6. The composition of claim 5 , wherein the trisodium citrate is present at a concentration of from about 3% to about 15% (weight/volume).

7. The composition of claim 1 , wherein the component capable of releasing an aldehyde is present at a concentration of from about 10% to about 40% (weight/volume).

8. The composition of claim 1 , wherein the α-cyclodextrin is present at a concentration of from about 0.75% to about 4%.

9. A method of treating a single blood sample with the composition of claim 1 , comprising contacting the sample with the composition and isolating one or more of DNA, RNA, extracellular vesicles, circulating tumor cells, circulating rare cells, or proteins from the sample.

10. A method of inhibiting lysis of a cell comprising contacting the cell with a composition of claim 1 , wherein the inhibiting prevents release of nucleic acid and/or an extracellular vesicle from the cell.

11. The method of claim 10 , wherein the cell is a white blood cell.

12. The method of claim 10 , wherein the cell is a red blood cell.

13. The method of claim 10 , wherein the nucleic acid is cell free RNA (cfRNA), cell free DNA (cfDNA), cellular RNA, or cellular DNA.

14. The method of claim 10 , wherein lysis is inhibited for at least about 24 hours.

15. The method of claim 14 , wherein lysis is inhibited by at least 2 days, or at least 3 days, or at least 4 days.

16. The method of claim 10 , further comprising maintaining the cell for at least about 24 hours and then isolating the nucleic acid from the cell.

17. The method of claim 16 , wherein the cell is maintained at room temperature.

Assignments (4)
SECURITY INTEREST Recorded Feb 21, 2023
From: STRECK LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 062819/0851 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2023
From: STRECK, INC.
To: STRECK LLC
Reel/Frame 062766/0015 →
SECURITY INTEREST Recorded Apr 23, 2021
From: STRECK, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 056016/0124 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 12, 2020
From: GEORGE, NICHOLAS MICHAEL; HUNSLEY, BRADFORD A.
To: STRECK, INC.
Reel/Frame 053466/0452 →
Continuity (2)
Provisional Application 62574515 · Oct 19, 2017
Related Publication 20210371848A1 · Dec 2, 2021
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