# US 8,541,180 B1 · Compositions and methods for assessing gastrointestinal health

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- Number: US 8,541,180 B1
- Document ID: US8541180B1
- Status: Granted
- Kind: B1
- Application number: 12/901,967
- Filed: 2010-10-11
- Granted: 2013-09-24
- Earliest claimed: 2010-10-11
- Assignees: Genova Diagnostics, Inc.
- Applicants: Patrick Hanaway; Jeffrey Ledford
- Inventors: Patrick Hanaway; Jeffrey Ledford
- Web page: https://patentgrep.com/patent/US8541180B1

## CPC

- G01N 33/56905: {Protozoa}
- C12Q 1/04: Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q1/6897 takes precedence)}
- G01N 33/573: for enzymes or isoenzymes
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2333/44: from protozoa
- G01N 2333/4727: Calcium binding proteins, e.g. calmodulin
- G01N 2333/96433: Serine endopeptidases (3.4.21)
- G01N 2800/065: Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 6)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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