IP Library Granted Patent US 11,634,781
Granted Patent B2
US 11,634,781 · App. 17/936,335 · Granted Apr 25, 2023

Fecal sample processing and analysis comprising detection of blood

Inventor: Joost Louwagie (Dornach, CH)
C12Q1/6886G01N33/57446C12Q2600/106C12Q2600/154C12Q2600/158G01N2333/805G01N2800/50G01N2800/52
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,634,781
App. No.
17/936,335
Granted
Apr 25, 2023
Kind
B2
Abstract

A method of processing a fecal sample from a human subject comprising removing a portion of a collected fecal sample and adding the removed portion of the sample to a buffer that prevents denaturation or degradation of blood proteins found in the sample, and detecting the presence of human blood in the removed portion of the fecal sample. The method further comprises stabilizing the remaining portion of the fecal sample.

Claims (31)

1. A method of processing a freshly-collected fecal sample without freezing, the method comprising:

a) collecting a fecal sample from a human subject, wherein the fecal sample is collected at home by the human subject by defecation directly into a sealable collection vessel;

b) removing a portion of the fecal sample to a separate sealable container to produce a removed portion and a remaining portion of the fecal sample;

c) combining the removed portion of the fecal sample in the separate sealable container with a buffer that prevents denaturation or degradation of blood proteins found in a fecal sample, and sealing the sealable container; and

d) combining the remaining portion of the fecal sample in the sealable collection vessel with a stabilizing buffer, and sealing the sealable collection vessel.

2. The method of claim 1 , further comprising delivering the sealable container containing the removed portion of the fecal sample and said buffer and the sealable collection vessel containing the remaining portion of the fecal sample and said stabilizing buffer to a medical diagnostics laboratory.

3. A method of processing a fecal sample, the method comprising:

a) obtaining a pair of portions of a fecal sample collected from a human subject, the pair of portions comprising:

i) a sealed sealable container containing a removed portion of a fecal sample and a buffer; and

ii) a sealed sealable collection vessel containing a remaining portion of a fecal sample and a stabilizing buffer,

the pair of portions obtained by the method of claim 1 ;

b) testing the removed portion of the fecal sample for an amount of a blood protein present in the removed portion;

c) extracting nucleic acid from the remaining portion of the fecal sample; and

d) testing the nucleic acid for an amount of a human nucleic acid.

4. The method of claim 3 , wherein testing the nucleic acid comprises determining expression from a human gene.

5. The method of claim 4 , wherein determining expression from the human gene comprises testing the nucleic acid for the presence of human DNA having an epigenetic modification.

6. The method of claim 5 , wherein testing the nucleic acid for the presence of human DNA having an epigenetic modification comprises measuring an amount of a methylated human DNA.

7. The method of claim 5 , wherein the epigenetic modification comprises aberrant methylation.

8. The method of claim 7 , wherein the aberrant methylation comprises hypermethylation.

9. The method of claim 5 , wherein the human DNA having an epigenetic modification comprises a gene and/or a promoter region of a gene.

10. The method of claim 9 , wherein the gene is selected from the group consisting of PHACTR3, NDRG4, FOXE1, GATA4, GPNMB, TFP12, SOX17, SYNE1, LAMA, MMP2, OSMR, SFRP2, and CDO1.

11. The method of claim 5 , wherein testing the nucleic acid for the presence of human DNA having an epigenetic modification comprises modifying the nucleic acid with bisulfate ions under conditions wherein unmethylated cytosine is converted to uracil.

12. The method of claim 4 , wherein determining expression from the human gene comprises measuring an amount of RNA expressed from the gene.

13. The method of claim 12 , wherein measuring an amount of RNA expressed from the gene comprises reverse transcriptase polymerase chain reaction (RT-PCR).

14. The method of claim 3 , wherein testing for an amount of a blood protein in the removed portion comprises testing for a concentration of hemoglobin in the removed portion.

15. The method of claim 14 , wherein testing for the concentration of hemoglobin comprises immunochemical detection of hemoglobin.

16. The method of claim 14 , wherein the removed portion of the fecal sample is considered positive for the presence of blood when the concentration of hemoglobin detected in the removed portion is at least 5 ng/ml.

17. The method of claim 14 , wherein the removed portion of the fecal sample is considered positive for the presence of blood when the concentration of hemoglobin detected in the removed portion is at least 10 ng/ml.

18. The method of claim 14 , wherein the removed portion of the fecal sample is considered positive for the presence of blood when the concentration of hemoglobin detected in the removed portion is at least 20 ng/ml.

19. The method of claim 14 , wherein the removed portion of the fecal sample is considered positive for the presence of blood when the concentration of hemoglobin detected in the removed portion is at least 50 ng/ml.

20. The method of claim 14 , wherein the removed portion of the fecal sample is considered positive for the presence of blood when the concentration of hemoglobin detected in the removed portion is at least 200 ng/ml.

Assignments (4)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT RIGHTS (REEL/FRAME 69898/0249) Recorded Mar 27, 2026
From: JPMORGAN CHASE BANK, N.A.
To: EXACT SCIENCES CORPORATION
Reel/Frame 075288/0393 →
PATENT SECURITY AGREEMENT Recorded Jan 14, 2025
From: EXACT SCIENCES CORPORATION
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 069898/0249 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 23, 2023
From: JOOST, LOUWAGIE
To: MDXHEALTH SA
Reel/Frame 062451/0127 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 23, 2023
From: MDXHEALTH SA
To: EXACT SCIENCES CORPORATION
Reel/Frame 062451/0195 →
Continuity (5)
Continuation 15634607 · Jun 27, 2017
Continuation 15010436 · Jan 29, 2016
Continuation 13147570
Provisional Application 61149581 · Feb 3, 2009
Related Publication 20230048152A1 · Feb 16, 2023
Cited By (4)
US 12,188,093 US 12,319,969 US 12,601,011 US 12,606,873