Flow CAST® Peanut Trial

Clinical Evaluation of Flow CAST® as an Aid in the Diagnosis of Peanut Allergy

This will be a multi-center, prospective evaluation, conducted at a minimum of four (4) U.S. sites. Sites will enroll peanut allergic subjects, subjects with allergies other than peanut and apparently healthy non-atopic control subjects and collect blood samples for testing using Flow CAST® and the comparative ImmunoCAP sIgE test.

Study subjects will be enrolled into one of the following 3 groups: healthy non-atopic subjects with no history of allergies, atopic subjects with confirmed peanut allergy, atopic subjects with a diagnosed allergy but confirmed negative for peanut allergy.

Subgroup analysis will be performed for each of the above categories.

Inclusion Criteria:

• Individual undergoing a blood draw
• Individual willing and able to provide two additional tubes of blood (3ml each tube) for research purposes
• Individual or legal guardian will and able to sign the informed consent form to participate in the study

Exclusion Criteria:

• Individual has undergone immunotherapy for peanuts or other identified allergens that have been shown to cause allergic symptoms
• Individual has been exposed to systemically administered glucocorticoids within the last 24 hours.
• Individual has been recently exposed to small molecule immunosuppressive medications
• Individual has been recently exposed to treatment with biologics interfering with the type-I allergic pathway
• Individual is currently involved in another "allergy treatment related" clinical research study