Compositions, devices, and methods of migraine headache food sensitivity testing
AssigneeBiomerica, Inc.
InventorsZackary Irani-Cohen, Elisabeth Laderman
Life of this patent
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Abstract
Contemplated test kits and methods for food sensitivity are based on rational-based selection of food preparations with established discriminatory p-value. Exemplary 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.
Claims101
A test kit for testing for food intolerance in a patient diagnosed with, or suspected of having, migraine headaches, the test kit comprising:
- one or more distinct food preparations, wherein each of the one or more food preparation is independently coupled to an individually addressable solid carrier;
- and
- wherein each of the one or more distinct food preparation has an average discriminatory p-value of ≤0.07 as determined by raw p-value, or an average discriminatory p-value of ≤0.10 as determined by FDR multiplicity adjusted p-value, wherein the average discriminatory p-value is determined by a process comprising comparing assay values of a first patient test cohort that is diagnosed with or suspected of having migraine headaches with assay values of a second patient test cohort that is not diagnosed with or suspected of having migraine headaches.
A method comprising:
- contacting a food preparation, said food preparation having at least one component, with a bodily fluid of a patient that is diagnosed with or suspected of having migraine headaches, wherein the bodily fluid comprises at least one immunoglobulin, wherein the bodily fluid is associated with a gender identification, and wherein the contacting is performed under conditions that allow at least a portion of the immunoglobulin to bind to the at least one component;
- measuring the portion of the immunoglobulin bound to the at least one component of the food preparation to obtain a signal;
- comparing the signal to a gender-stratified reference value for the food preparation using the gender identification to obtain a result;
- and
- updating or generating a report using the result.
A method of generating a test for food intolerance in patients diagnosed with or suspected to have migraine headaches, comprising:
- obtaining test results for one or more distinct food preparations, wherein the test results are derived from a process comprising contacting each food preparation with bodily fluids of a first patient test cohort that is diagnosed with or suspected of having migraine headaches, and contacting each food preparation with bodily fluids of a second patient test cohort that is not diagnosed with or suspected of having migraine headaches;
- and
- stratifying the test results by gender group for each of the distinct food preparations.
Use of a one or more distinct food preparations each independently coupled to separate, individually addressable solid carriers, wherein said use is implemented in a diagnosis of migraine headaches, wherein each distinct food preparations has an average discriminatory p-value of ≤0.07 as determined by raw p-value or an average discriminatory p-value of ≤0.10 as determined by FDR multiplicity adjusted p-value.
Dependencies are inferred from the claim text.