# US 2019/0170768 A1 · Compositions, devices, and methods of crohn's disease sensitivity testing

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- Number: US 2019/0170768 A1
- Document ID: US20190170768A1
- Status: Published application
- Kind: A1
- Application number: 16/171,154
- 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/US20190170768A1

## CPC

- G01N 33/6854: {Immunoglobulins}
- G01N 33/543: with an insoluble carrier for immobilising immunochemicals
- G01N 33/544: the carrier being organic
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- 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)

## 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

A Crohn's Disease test kit panel consisting essentially of:
a plurality of distinct Crohn's Disease food preparations immobilized to an individually addressable solid carrier;
wherein the plurality of distinct Crohn's Disease 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 Crohn's Disease food preparations includes at least two food preparations selected from the group consisting of almond, apple, avocado, barley, broccoli, buck wheat, cabbage, sugar cane, cantaloupe, carrot, cauliflower, celery, chili pepper, chocolate, clam, cola nut, corn, cucumber, eggplant, garlic, grapefruit, green pea, green pepper, honey, lemon, lettuce, lima bean, malt, mustard, oat, olive, onion, orange, oyster, peach, pinto bean, potato, rice, rye, safflower, sardine, scallop, soybean, spinach, squashes, strawberry, string bean, sunflower seed, sweet potato, tea, tobacco, tomato, walnut, wheat, baker's yeast, brewer's yeast, peanut, pineapple, sole, blueberry, grape, chicken, cinnamon, turkey, butter, cottage cheese, cashew, yogurt, cow's milk, egg, millet, coffee, halibut, beef, Swiss cheese, lobster, parsley, pork, shrimp, cheddar cheese, goat's milk, banana, and American cheese.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct Crohn's Disease food preparations includes at least eight food.

### Claim 5 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct Crohn's Disease 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 Crohn's Disease 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

-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

-13. (canceled)

### Claim 14 (depends on 1)

The test kit panel of claim 1 wherein at least 50% of the plurality of distinct Crohn's Disease 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

-19. (canceled)

### Claim 20 (depends on 1)

The test kit panel of claim 1 wherein the plurality of distinct Crohn's Disease food preparations is a crude filtered aqueous extract or a processed aqueous extract.

### Claim at position 13

-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 a well of a multiwell 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 Crohn's Disease trigger food preparations with a bodily fluid of a patient that is diagnosed with or suspected of having Crohn's Disease;
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 Crohn's Disease trigger food preparations;
measuring the immunoglobulin bound to the at least one component of the plurality of distinct Crohn's Disease trigger food preparations to obtain a signal; and
updating or generating a report using the signal.

### Claim at position 17

-29. (canceled)

### Claim 30 (depends on 26)

The method of claim 26 wherein the plurality of distinct Crohn's Disease trigger food preparations is selected from the group consisting of almond, apple, avocado, barley, broccoli, buck wheat, cabbage, sugar cane, cantaloupe, carrot, cauliflower, celery, chili pepper, chocolate, clam, cola nut, corn, cucumber, eggplant, garlic, grapefruit, green pea, green pepper, honey, lemon, lettuce, lima bean, malt, mustard, oat, olive, onion, orange, oyster, peach, pinto bean, potato, rice, rye, safflower, sardine, scallop, soybean, spinach, squashes, strawberry, string bean, sunflower seed, sweet potato, tea, tobacco, tomato, walnut, wheat, baker's yeast, brewer's yeast, peanut, pineapple, sole, blueberry, grape, chicken, cinnamon, turkey, butter, cottage cheese, cashew, yogurt, cow's milk, egg, millet, coffee, halibut, beef, Swiss cheese, lobster, parsley, pork, shrimp, cheddar cheese, goat's milk, banana, and American cheese.

### Claim 31

(canceled)

### Claim 32 (depends on 26)

The method of claim 26, wherein the plurality of distinct Crohn's Disease 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 Crohn's Disease 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

-45. (canceled)

### Claim 46

A method of generating a test for patients diagnosed with or suspected of having Crohn's Disease, 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 Crohn's Disease and bodily fluids of a control group not diagnosed with or not suspected of having Crohn's Disease;
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 Crohn's Disease 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 Crohn's Disease trigger food preparations.

### Claim 47

(canceled)

### Claim 48 (depends on 46)

The method of claim 46 wherein the plurality of distinct Crohn's Disease trigger food preparations includes at least two food preparations selected from the group consisting of almond, apple, avocado, barley, broccoli, buck wheat, cabbage, sugar cane, cantaloupe, carrot, cauliflower, celery, chili pepper, chocolate, clam, cola nut, corn, cucumber, eggplant, garlic, grapefruit, green pea, green pepper, honey, lemon, lettuce, lima bean, malt, mustard, oat, olive, onion, orange, oyster, peach, pinto bean, potato, rice, rye, safflower, sardine, scallop, soybean, spinach, squashes, strawberry, string bean, sunflower seed, sweet potato, tea, tobacco, tomato, walnut, wheat, baker's yeast, brewer's yeast, peanut, pineapple, sole, blueberry, grape, chicken, cinnamon, turkey, butter, cottage cheese, cashew, yogurt, cow's milk, egg, millet, coffee, halibut, beef, Swiss cheese, lobster, parsley, pork, shrimp, cheddar cheese, goat's milk, banana, and American cheese.

### Claim at position 27

-53. (canceled)

### Claim 54 (depends on 46)

The method of claim 46 wherein the plurality of distinct Crohn's Disease 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

-61. (canceled)

### Claim 62 (depends on 46)

The mccethod 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

-100. (canceled)