FDA approves Phadia's allergy diagnosis test

PORTAGE, Mich. Phadia on Thursday announced the recent Food and Drug Administration clearance of ImmunoCAP Rapid, the first point-of-care test to assist in the diagnosis of allergy in the practitioner’s office.

“This is another significant step in our mission to make ImmunoCAP testing available to all the clinicians managing patients with allergic disease, including asthma and rhinitis,” stated Michael Land, president of Phadia US. “In an era when the prevalence of allergy and asthma is described by many as ‘an epidemic,’ ImmunoCAP Rapid gives physicians access to additional clinical information that can help them arrive at a definitive diagnosis. They can also inform patients about the presence or absence of allergic disease while they are still in the office.”

The original ImmunoCAP Specific IgE blood test technology measures Immunoglobulin E (IgE) antibodies to indoor, outdoor and food allergens in a small sample of blood.

ImmunoCAP was the first allergy test to be cleared by the FDA as a truly quantitative test for identifying allergen sensitization. Reducing exposure to a specific allergen that is the source of sensitization is recognized by the National Institutes of Health as one of the most important steps in the effective management of allergic asthma.

ImmunoCAP Rapid is designed to be used at the point of care. Needing only a small sample of whole blood taken from the fingertip, the single-use, disposable device provides a first look at the IgE profile for patients based on the 10 most common inhaled allergens in the United States.

The results are available in 20 minutes, allowing the practitioner to quickly make evidence-based decisions. In addition, this timeframe allows the practitioner and patient to discuss appropriate treatments, including targeted exposure reduction, while the patient is still in the office.