# US 2019/0170767 A1 · Compositions, devices, and methods of ulcerative colitis sensitivity testing

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- Number: US 2019/0170767 A1
- Document ID: US20190170767A1
- Status: Published application
- Kind: A1
- Application number: 16/170,969
- Filed: 2018-10-25
- Published: 2019-06-06
- Earliest claimed: 2016-04-26
- Applicants: Biomerica, Inc.
- Inventors: Zackary Irani-cohen; Elisabeth Laderman
- Web page: https://patentgrep.com/patent/US20190170767A1

## CPC

- G01N 33/6854: {Immunoglobulins}
- A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)}
- A61B 5/4255: {Intestines, colon or appendix}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Contemplated test kits and methods for food sensitivity are based on rational-based selection of food preparations with established discriminatory p-value. Particularly preferred kits include those with a minimum number of food preparations that have an average discriminatory p-value of ≤0.07 as determined by their raw p-value or an average discriminatory p-value of ≤0.10 as determined by FDR multiplicity adjusted p-value. In further contemplated aspects, compositions and methods for food sensitivity are also stratified by gender to further enhance predictive value.

## Claims

### Claim 1

An ulcerative colitis test kit panel consisting essentially of:
a plurality of distinct ulcerative colitis food preparations immobilized to an individually addressable solid carrier;
wherein the plurality of distinct ulcerative colitis food preparations each have a raw p-value of ≤0.07 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.

### Claim 2 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct ulcerative colitis food preparations includes at least two food preparations selected from the group consisting of green pea, cantaloupe, pinto bean, cucumber, green pepper, grapefruit, carrot, orange, almond, sardine, sweet potato, broccoli, garlic, lima bean, squashes, celery, string bean, tomato, cauliflower, walnut, sunflower seed, sugar cane, buck wheat, soybean, lemon, barley, oat, oyster, mustard, rye, peach, chili pepper, spinach, peanut, avocado, shrimp, pineapple, cola nut, rice, cabbage, butter, eggplant, apple, egg, wheat, cottage cheese, sole, cashew, olive, parsley, corn, honey, chocolate, cow's milk, potato, onion, tea and tobacco.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct ulcerative colitis food preparations includes at least eight food preparations.

### Claim 5 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct ulcerative colitis food preparations includes at least 12 food preparations.

### Claim 6 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct ulcerative colitis food preparations each have a p-value of ≤0.05 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.08.

### Claim at position 7

7-9. (canceled)

### Claim 10 (depends on 1)

The test kit panel of claim 1 wherein FDR multiplicity adjusted p-value is adjusted for at least one of age or gender.

### Claim at position 9

11-13. (canceled)

### Claim 14 (depends on 1)

The test kit panel of claim 1 wherein at least 50% of the plurality of distinct ulcerative colitis food preparations, when adjusted for a single gender, have a raw p-value of ≤0.07 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.10.

### Claim at position 11

15-19. (canceled)

### Claim 20 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct ulcerative colitis food preparations is a crude filtered aqueous extract or a processed aqueous extract.

### Claim at position 13

21-23. (canceled)

### Claim 24 (depends on 1)

The test kit panel of claim 1 wherein the solid carrier is selected from the group consisting of an array, a micro well plate, a dipstick, a membrane-bound array, a bead, an electrical sensor, a chemical sensor, a microchip or an adsorptive film.

### Claim 25

(canceled)

### Claim 26

A method of testing food sensitivity comprising:
contacting a test kit panel consisting essentially of a plurality of distinct ulcerative colitis trigger food preparations with a bodily fluid of a patient that is diagnosed with or suspected of having ulcerative colitis;
wherein the step of contacting is performed under conditions that allow at least a portion of an immunoglobulin from the bodily fluid to bind to at least one component of the plurality of distinct ulcerative colitis trigger food preparations;
measuring the immunoglobulin bound to the at least one component of the plurality of distinct ulcerative colitis trigger food preparations to obtain a signal;
and
updating or generating a report using the signal.

### Claim at position 17

27-29. (canceled)

### Claim 30 (depends on 26)

The method of claim 26 wherein the plurality of distinct ulcerative colitis trigger food preparations is selected from the group consisting of green pea, cantaloupe, pinto bean, cucumber, green pepper, grapefruit, carrot, orange, almond, sardine, sweet potato, broccoli, garlic, lima bean, squashes, celery, string bean, tomato, cauliflower, walnut, sunflower seed, sugar cane, buck wheat, soybean, lemon, barley, oat, oyster, mustard, rye, peach, chili pepper, spinach, peanut, avocado, shrimp, pineapple, cola nut, rice, cabbage, butter, eggplant, apple, egg, wheat, cottage cheese, sole, cashew, olive, parsley, corn, honey, chocolate, cow's milk, potato, onion, tea and tobacco.

### Claim 31

(canceled)

### Claim 32 (depends on 26)

The method of claim 26, wherein the plurality of distinct ulcerative colitis trigger food preparations each have a raw p-value of ≤0.07 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.10.

### Claim 33

(canceled)

### Claim 34 (depends on 26)

The method of claim 26, wherein the plurality of distinct ulcerative colitis trigger food preparations each have a raw p-value of ≤0.05 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.08.

### Claim at position 23

35-45. (canceled)

### Claim 46

A method of generating a test for patients diagnosed with or suspected of having ulcerative colitis, comprising:
obtaining test results for a plurality of distinct food preparations, wherein the test results are based on bodily fluids of patients diagnosed with or suspected of having ulcerative colitis and bodily fluids of a control group not diagnosed with or not suspected of having ulcerative colitis; stratifying the test results by gender for each of the distinct food preparations;
assigning for a predetermined percentile rank a different cutoff value for male and female patients for each of the distinct food preparations;
selecting a plurality of distinct ulcerative colitis trigger food preparations that each have a raw p-value of ≤0.07 or a FDR multiplicity adjusted p-value of ≤0.10; and
generating a test comprising the selected distinct ulcerative colitis trigger food preparations.

### Claim 47

(canceled)

### Claim 48 (depends on 46)

The method of claim 46 wherein the plurality of distinct ulcerative colitis trigger food preparations includes at least two food preparations selected from the group consisting of green pea, cantaloupe, pinto bean, cucumber, green pepper, grapefruit, carrot, orange, almond, sardine, sweet potato, broccoli, garlic, lima bean, squashes, celery, string bean, tomato, cauliflower, walnut, sunflower seed, sugar cane, buck wheat, soybean, lemon, barley, oat, oyster, mustard, rye, peach, chili pepper, spinach, peanut, avocado, shrimp, pineapple, cola nut, rice, cabbage, butter, eggplant, apple, egg, wheat, cottage cheese, sole, cashew, olive, parsley, corn, honey, chocolate, cow's milk, potato, onion, tea and tobacco.

### Claim at position 27

49-53. (canceled)

### Claim 54 (depends on 46)

The method of claim 46 wherein the plurality of distinct ulcerative colitis trigger food preparations each have a raw p-value of ≤0.07 or a FDR multiplicity adjusted p-value of ≤0.10.

### Claim at position 29

55-61. (canceled)

### Claim 62 (depends on 46)

The method of claim 46 wherein the predetermined percentile rank is an at least 90th percentile rank.

### Claim 63

(canceled)

### Claim 64 (depends on 46)

The method of claim 46 wherein the cutoff value for male and female patients has a difference of at least 10% (abs).

### Claim 65

(canceled)

### Claim 66 (depends on 46)

The method of claim 46, further comprising a step of normalizing the result to the patient's total IgG.

### Claim 67

(canceled)

### Claim 68 (depends on 46)

The method of claim 46, further comprising a step of normalizing the result to the global mean of the patient's food specific IgG results.

### Claim at position 37

69-100. (canceled)