IP Library Granted Patent US 8,541,180
Granted Patent B1
US 8,541,180 · App. 12/901,967 · Granted Sep 24, 2013

Compositions and methods for assessing gastrointestinal health

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Quick Facts
Patent No.
US 8,541,180
App. No.
12/901,967
Granted
Sep 24, 2013
Kind
B1
Abstract

The present invention relates to kits designed for the collection of stool samples and methods of analyzing those samples for biological markers of maldigestion, inflammation, and imbalanced gut flora.

Claims (11)

1. A method comprising a plurality of tests to assist with the diagnosis of irritable bowel syndrome (IBS), the method comprising:

(a) providing a stool sample from a patient; and

(b) subjecting the sample to an evaluation of (i) an elastase that is produced by the pancreas and remains detectable in the stool following passage through the intestine, (ii) calprotectin, and (iii) gut flora, wherein levels of the elastase less than about 350 μg/gram of stool, levels of calprotectin less than about 120 μg/gram of stool, and insufficient levels of beneficial gut flora indicate a diagnosis of IBS.

2. The method of claim 1 , wherein the evaluation of gut flora comprises an evaluation of bifidobacteria species, lactobacillus species, and Escherichia coli.

3. The method of claim 1 , further comprising testing for celiac disease, wherein the absence of celiac disease reinforces the diagnosis of IBS.

4. The method of claim 1 , further comprising testing for occult blood in the stool sample, wherein the absence of occult blood reinforces the diagnosis of IBS.

5. The method of claim 1 , wherein the method is performed and then repeated about six weeks later.

6. The method of claim 1 , further comprising a step of identifying a patient as a candidate for testing.

7. The method of claim 6 , wherein the patient is one complaining of abdominal pain, gas, bloating, constipation, or diarrhea.

8. The method of claim 1 , wherein the level of the elastase is less than about 250 μg/gram of stool.

9. The method of claim 1 , wherein the level of calprotectin is less than about 50 μg/gram of stool.

Assignments (8)
RELEASE OF SECURITY INTEREST Recorded Dec 24, 2025
From: GNVA DEBT HOLDCO 2, LLC
To: GENOVA DIAGNOSTICS, INC.
Reel/Frame 073311/0599 →
RELEASE OF SECURITY INTEREST Recorded Dec 24, 2025
From: BANK OF MONTREAL
To: GENOVA DIAGNOSTICS, INC.
Reel/Frame 073311/0767 →
SECURITY INTEREST Recorded Dec 24, 2025
From: GENOVA DIAGNOSTICS, INC.
To: THIRD POINT CAPITAL MARKETS LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 073312/0271 →
SECOND LIEN PATENT SECURITY AGREEMENT Recorded Oct 27, 2020
From: GENOVA DIAGNOSTICS, INC.
To: GNVA DEBT HOLDCO 2, LLC
Reel/Frame 054228/0081 →
RELEASE OF THE SECURITY INTEREST RECORDED AT REEL/FRAME 031664/0789 Recorded Nov 13, 2018
From: GNVA DEBT HOLDCO, LLC
To: GENOVA DIAGNOSTICS, INC.
Reel/Frame 047511/0383 →
SECOND LIEN PATENT SECURITY AGREEMENT Recorded Nov 18, 2013
From: GENOVA DIAGNOSTICS, INC.
To: GNVA DEBT HOLDCO, LLC
Reel/Frame 031664/0789 →
RELEASE OF SECURITY INTEREST Recorded Nov 13, 2013
From: FIFTH THIRD BANK
To: GENOVA DIAGNOSTICS, INC.; DIAGNOSTICS SECURITY HOLDERS, LLC
Reel/Frame 031595/0924 →
SECURITY AGREEMENT Recorded Nov 13, 2013
From: GENOVA DIAGNOSTICS, INC.
To: BANK OF MONTREAL, AS ADMINISTRATIVE AGENT
Reel/Frame 031629/0704 →