US2021148930A1PendingUtilityA1

Methods of Detecting and Preventing Atopic Allergic Diseases

Assignee: NAT JEWISH HEALTHPriority: Dec 22, 2015Filed: Oct 23, 2020Published: May 20, 2021
Est. expiryDec 22, 2035(~9.4 yrs left)· nominal 20-yr term from priority
G01N 33/6881G01N 2800/50G01N 2333/52G01N 33/6863G01N 33/6893G01N 2800/24
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Claims

Abstract

The present invention is related to novel methods for identifying a population of subjects that are at risk for developing of atopic allergic diseases, and to the prevention of these allergic diseases.

Claims

exact text as granted — not AI-modified
1 . A method to identify a subject at risk of developing an allergic disease comprising:
 a. obtaining a skin sample from the subject;   b. determining the expression level of thymic stromal lymphopoietin (TSLP) in the skin sample; and   c. comparing the expression level of TSLP in the skin sample to a control sample wherein an increased expression level of TSLP as compared to the control sample identifies the subject as being at risk to develop an allergic disease.   
     
     
         2 . The method of  claim 1 , wherein the allergic disease is selected from the group consisting of atopic dermatitis, food allergy, asthma and allergic rhinitis. 
     
     
         3 . The method of  claim 1  wherein the skin sample is obtained by a skin tape stripping method. 
     
     
         4 . The method of  claim 1 , wherein the expression level of TSLP is determined by a method selected from the group consisting of mass spectrometry, Western Blotting, Elisa and PCR. 
     
     
         5 . The method of  claim 1 , wherein the skin sample is an epidermal skin sample. 
     
     
         6 . The method of  claim 1 , wherein the subject is a human infant. 
     
     
         7 . The method of  claim 1 , wherein the subject identified as being at risk to develop an allergic disease is administered a TSLP inhibiting agent is selected from the group consisting of humanized antibodies that neutralize TSLP action and antibodies that bind to the TSLP receptor. 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 1 , wherein the subject identified as being at risk to develop an allergic disease is administered a moisturizer. 
     
     
         11 . A method of diagnosing and treating an allergic disease in an asymptomatic subject, comprising:
 a. obtaining a skin sample from the subject;   b. determining the expression level of thymic stromal lymphopoietin (TSLP) in the skin sample;   c. comparing the expression level of TSLP in the skin sample to a control sample wherein a statically significant increased expression level of TSLP as compared to the control sample identifies the subject as having an allergic disease; and   d. administering an effective amount of a topical or systemic therapeutic to the subject prior to development of allergic disease symptoms.   
     
     
         12 . The method of  claim 11 , wherein the allergic disease is selected from the group consisting of atopic dermatitis, food allergy, asthma and allergic rhinitis. 
     
     
         13 . The method of  claim 11 , wherein the skin sample is obtained by a skin tape stripping method. 
     
     
         14 . The method of  claim 11 , wherein the expression level of TSLP is determined by a method selected from the group consisting of mass spectrometry, Western Blotting, and Elisa, and PCR. 
     
     
         15 . The method of  claim 11 , wherein the topical therapeutic is selected from the group consisting of a moisturizer, topical anti-inflammatory medication and combinations thereof. 
     
     
         16 . The method of  claim 11 , wherein the method further comprises additional administration of the topical or systemic therapeutic upon development of allergic disease symptoms. 
     
     
         17 . The method of  claim 11 , wherein the method further comprises administration of a different topical or systemic therapeutic as compared to the topical or systemic therapeutic administered in step d. 
     
     
         18 . The method of  claim 11 , wherein the administration of the therapeutic prevents the development of allergic disease symptoms in the subject. 
     
     
         19 . The method of  claim 11 , wherein the administration of the therapeutic delays the onset of the allergic disease. 
     
     
         20 . The method of  claim 11 , wherein administration of the therapeutic reduces the severity of the allergic disease symptoms in the subject. 
     
     
         21 . A method to determine the expression level of thymic stromal lymphopoietin (TSLP) in a subject, comprising:
 a. adhering a skin tape to the skin of the subject;   b. removing the skin tape from the skin of the subject;   c. extracting the TSLP protein and/or RNA from the removed skin tape; and   d. measuring the extracted protein and/or RNA TSLP levels.   
     
     
         22 . The method of  claim 21 , wherein the TSLP levels are measured by a method selected from the group consisting of mass spectrometry, western blotting, Elisa and PCR.

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