IP Library Granted Patent US 11,761,025
Granted Patent B2
US 11,761,025 · App. 16/908,233 · Granted Sep 19, 2023

Preservation of cell-free nucleic acids

Inventor: M. Rohan Fernando (Omaha, NE)
Assignee: STRECK LLC
C12Q1/6806C09K15/20C12Q2527/125C12Q2527/127
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Quick Facts
Patent No.
US 11,761,025
App. No.
16/908,233
Granted
Sep 19, 2023
Kind
B2
Abstract

A method for preserving and processing cell-free nucleic acids located within a blood sample is disclosed, wherein a blood sample containing cell-free nucleic acids is treated to reduce both blood cell lysis and nuclease activity within the blood sample. The treatment of the sample aids in increasing the amount of cell-free nucleic acids that can be identified and tested while maintaining the structure and integrity of the nucleic acids.

Claims (24)

1. A composition for the stabilization of nucleic acids within a plasma sample comprising:

a. an amount of free formaldehyde;

b. about 200 to 500 g/L of one or more preservative agents including diazolidinyl urea;

c. a solvent including water;

wherein upon mixing the composition with a blood sample and storing the blood sample at room temperature for at least 7 days, cell-free RNA detection is improved due to reduced cellular RNA presence and a reduction in a decrease in cell-free RNA as a result of the composition.

2. The composition of claim 1 , wherein the one or more preservative agents includes imidazolidinyl urea.

3. The composition of claim 1 , further comprising one or more nuclease inhibitors that include an anticoagulant.

4. The composition of claim 2 , further comprising one or more nuclease inhibitors that include an anticoagulant.

5. The composition of claim 3 , wherein the one or more nuclease inhibitors includes EDTA.

6. The composition of claim 4 , wherein the one or more nuclease inhibitors includes EDTA.

7. The composition of claim 1 , wherein the one or more preservative agents includes imidazolidinyl urea, dimethyoylol-5,5dimethylhydantoin, dimethylol urea, 2-bromo-2-nitropropane-1,3-diol, oxazolidines, sodium hydroxymethyl glycinate, 5-hydroxymethoxymethyl-1-1aza-3,7-dioxabicyclo [3.3.0]octane, 5-hydroxymethyl-1-1aza-3,7dioxabicyclo[3.3.0]octane, quaternary adamantine and combinations thereof.

8. The composition of claim 5 , wherein the one or more preservative agents includes imidazolidinyl urea, dimethoylol-5,5dimethylhydantoin, dimethylol urea, 2-bromo-2-nitropropane-1,3-diol, oxazolidines, sodium hydroxymethyl glycinate, 5-hydroxymethoxymethyl-1-1aza-3,7-dioxabicyclo [3.3.0]octane, 5-hydroxymethyl-1-1aza-3,7dioxabicyclo[3.3.0]octane, 5-hydroxypoly[methyleneoxy]methyl-1-1aza-3,7dioxabicyclo[3.3.0]octane, quaternary adamantine and any combination thereof.

9. The composition of claim 1 , wherein the concentration of the one or more preservative agents is about 200 g/l to about 400 g/l.

10. The composition of claim 6 , wherein the concentration of the one or more preservative agents is about 200 g/l to about 400 g/l.

11. The composition of claim 8 , wherein the concentration of the one or more preservative agents is about 200 g/l to about 400 g/l.

12. The composition of claim 1 , wherein the composition is mixed with a blood sample so that the amount of the one or more preservative agents is less than 10 g/l of the blood sample.

13. The composition of claim 2 , wherein the composition is mixed with a blood sample so that the amount of the one or more preservative agents is less than 10 g/l of the blood sample.

14. The composition of claim 7 , wherein the composition is mixed with a blood sample so that the amount of the one or more preservative agents is less than 10 g/l of the blood sample.

15. The composition of claim 1 , wherein the composition is located into a tube having an interior wall that is flame sprayed, subjected to corona discharge, plasma treated, coated or otherwise treated.

16. The composition of claim 2 , wherein the composition is located into a tube having an interior wall that is flame sprayed, subjected to corona discharge, plasma treated, coated or otherwise treated.

17. The composition of claim 7 , wherein the composition is located into a tube having an interior wall that is flame sprayed, subjected to corona discharge, plasma treated, coated or otherwise treated.

18. The composition of claim 15 , wherein the interior wall includes a coating that is sprayed, dipped, swabbed, or otherwise applied onto some or all of the interior wall of the tube.

19. The composition of claim 16 , wherein the interior wall includes a coating that is sprayed, dipped, swabbed, or otherwise applied onto some or all of the interior wall of the tube.

20. The composition of claim 1 , wherein the composition is located into a tube that is glass.

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 19, 2020
From: FERNANDO, M. ROHAN
To: STRECK, INC.
Reel/Frame 053538/0230 →
Continuity (9)
Continuation 16377344 · Apr 8, 2019
Continuation 15937446 · Mar 27, 2018
Continuation 15894077 · Feb 12, 2018
Continuation 15601682 · May 22, 2017
Continuation 14071969 · Nov 5, 2013
Continuation 13648415 · Oct 10, 2012
Continuation 12704030 · Feb 11, 2010
Provisional Application 61153472 · Feb 18, 2009
Related Publication 20200318161A1 · Oct 8, 2020