Claims for Patent: 7,824,877

Summary for Patent: 7,824,877

Title:	Methods for diagnosing auto-immune chronic urticaria
Abstract:	In certain embodiments, the present invention relates to methods, compositions, and kits for diagnosing autoimmune chronic urticaria. For example, in certain embodiments, such methods generally comprise detecting the presence of auto-antibodies to cell-surface IgE receptors or cell-bound IgE in a patient. Such auto-antibodies may be detected by (a) obtaining donor basophils and associated leukocytes from one or more donors, (b) challenging the donor basophils and associated leukocytes with control serum and quantifying the amount of histamine released by the donor basophils and associated leukocytes, (c) calculating a normalized baseline of histamine release, wherein the normalized baseline of histamine release represents a mean percentage of histamine released by the basophils and associated leukocytes of an individual donor plus a specified amount above such mean, (d) reacting patient serum with the donor basophils and associated leukocytes, (e) measuring the percentage of histamine released by the donor basophils and associated leukocytes in response to the patient serum, and (f) comparing the percentage of histamine released by the donor basophils and associated leukocytes in response to the patient serum to the normalized baseline of histamine release.
Inventor(s):	Halsey; John Frederick (Prairie Village, KS), Altrich; Michelle Lee (Lenexa, KS)
Assignee:	Viracor-IBT Laboratories, Inc. (Lee\'s Summit, MO)
Application Number:	11/900,084
Patent Claims:	1. A method for diagnosing auto-immune chronic urticaria in a patient, the method comprising: reacting a serum sample from the patient with donor basophils and associated leukocytes obtained from an individual donor; measuring histamine released by the donor basophils and associated leukocytes in response to the patient serum; and using the measured histamine released to calculate a CU index score, wherein the CU index is represented by the following formula: (.alpha./.beta.)=CU Index, wherein .alpha. is the amount of histamine released by the donor basophils and associated leukocytes in response to the patient serum, and .beta. is a normalized baseline of histamine release, wherein the normalized baseline of histamine release is a mean percentage plus 1 or more standard deviations thereof of histamine released by the donor basophils and associated leukocytes following challenges with control sera obtained from serum donors that do not exhibit clinical symptoms of chronic urticaria; wherein the CU index score is an indicator of a diagnosis of auto-immune chronic urticaria in the patient. 2. The method of claim 1, wherein the diagnosis is positive for autoimmune chronic urticaria when the CU index score is 1 or more. 3. The method of claim 1, wherein the CU index multiplied by 10 to provide the CU index score. 4. The method of claim 3, wherein the diagnosis is positive for autoimmune chronic urticaria when the CU index score is 10 or more. 5. The method of claim 1, wherein said measuring is by histamine Enzyme-Linked Immunoassay (ELISA). 6. The method of claim 3, wherein said measuring is by Histamine Enzyme-Linked Immunoassay (ELISA). 7. The method of claim 1, wherein a CU index score of 1 or more indicates that the patient should be treated with an immune modulating drug. 8. The method of claim 3, wherein a CU index score of 10 or more indicates that the patient should be treated with an immune modulating drug. 9. The method of claim 1, wherein the normalized baseline of histamine release is a mean percentage plus 2 or more standard deviations of histamine released by donor basophils and associated leukocytes of an individual donor following challenge with a control serum obtained from one or more donors that do not exhibit clinical symptoms of chronic urticaria. 10. The method of claim 1, wherein the normalized baseline of histamine release is a mean percentage plus about 2 standard deviations of histamine released by donor basophils and associated leukocytes of an individual donor following challenge with a control serum obtained from one or more donors that do not exhibit clinical symptoms of chronic urticaria. 11. A method for monitoring efficacy of an immune modulating drug in treatment of auto- immune chronic urticaria in a patient to whom the drug was administered, the method comprising: reacting a serum sample from the patient with donor basophils and associated leukocytes obtained from an individual donor; measuring histamine released by the donor basophils and associated leukocytes in response to the patient serum; and using the measured histamine released to calculate a CU index score, wherein the CU index is represented by the following formula: (.alpha./.beta.)=CU Index, wherein .alpha. is the amount of histamine released by the donor basophils and associated leukocytes in response to the patient serum, and .beta. is a normalized baseline of histamine release, wherein the normalized baseline of histamine release is a mean percentage plus 1 or more standard deviations thereof of histamine released by the donor basophils and associated leukocytes following challenges with control sera obtained from serum donors that do not exhibit clinical symptoms of chronic urticaria; wherein the CU index score is an indicator of efficacy of the immune modulating drug in the patient. 12. The method of claim 11, wherein the CU index multiplied by 10 to provide the CU index score. 13. The method of claim 11, wherein the normalized baseline of histamine release is a mean percentage plus 2 or more standard deviations of histamine released by donor basophils and associated leukocytes of an individual donor following challenge with a control serum obtained from one or more donors that do not exhibit clinical symptoms of chronic urticaria. 14. The method of claim 11, wherein the normalized baseline of histamine release is a mean percentage plus about 2 standard deviations of histamine released by donor basophils and associated leukocytes of an individual donor following challenge with a control serum obtained from one or more donors that do not exhibit clinical symptoms of chronic urticaria. 15. The method of claim 11, wherein said measuring is by histamine Enzyme-Linked Immunoassay (ELISA). 16. The method of claim 12, wherein said measuring is by histamine Enzyme-Linked Immunoassay (ELISA). 17. A method for determining whether a subject should be included in a clinical trial of a candidate drug for treatment of chronic urticaria, the method comprising: reacting a serum sample from the patient with donor basophils and associated leukocytes obtained from an individual donor; measuring histamine released by the donor basophils and associated leukocytes in response to the patient serum; and using the measured histamine released to calculate a CU index score, wherein the CU index is represented by the following formula: (.alpha./.beta.)=CU Index, wherein .alpha. is the amount of histamine released by the donor basophils and associated leukocytes in response to the patient serum, and .beta. is a normalized baseline of histamine release, wherein the normalized baseline of histamine release is a mean percentage plus 1 or more standard deviations thereof of histamine released by the donor basophils and associated leukocytes following challenges with control sera obtained from serum donors that do not exhibit clinical symptoms of chronic urticaria; wherein the CU index score is an indicator of efficacy of the immune modulating drug in the patient. 18. The method of claim 17, wherein the CU index multiplied by 10 to provide the CU index score. 19. The method of claim 17, wherein the normalized baseline of histamine release is a mean percentage plus 2 or more standard deviations of histamine released by donor basophils and associated leukocytes of an individual donor following challenge with a control serum obtained from one or more donors that do not exhibit clinical symptoms of chronic urticaria. 20. The method of claim 17, wherein the normalized baseline of histamine release is a mean percentage plus about 2 standard deviations of histamine released by donor basophils and associated leukocytes of an individual donor following challenge with a control serum obtained from one or more donors that do not exhibit clinical symptoms of chronic urticaria. 21. The method of claim 17, wherein said measuring is by histamine Enzyme-Linked Immunoassay (ELISA). 22. The method of claim 18, wherein said measuring is by histamine Enzyme-Linked Immunoassay (ELISA).

Details for Patent 7,824,877

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	03/13/1924		2040-01-28