Phadia's ImmunoCAP Rapid System receives FDA marketing clearance

Phadia, the world leader in allergy blood testing diagnostics, today announced that the United States Food and Drug Administration (FDA) has cleared the ImmunoCAP^® Rapid Reader II, a part of the ImmunoCAP Rapid System, used to aid in the diagnosis of allergy in the physician’s office.

“By bringing allergy testing directly to the physician’s office, Phadia is providing physicians with new tools to improve patient care. These innovative new tests will help drive improvements in the assessment and management of patients, particularly those with asthma and other potentially allergic problems.”

This clearance now allows Phadia to begin marketing the ImmunoCAP Rapid System to physicians throughout the United States having laboratories that meet CLIA standards for Moderately Complex testing. The test requires a simple capillary blood draw and test results are available to the physician in 20 minutes.

Up to 90 percent of all pediatric asthma patients have allergies and up to 60% of adult asthma patient have allergies that trigger their asthma attacks. Reducing exposure to these allergens is a key recommendation of the NIH-funded National Asthma Education and Prevention Program and is an important step in the effective management of allergic asthma.

In addition, 50 percent of rhinitis patients suffer from allergies. With ImmunoCAP Rapid, physicians who treat asthma and rhinitis patients will have semi-quantitative measurements of IgE levels for ten common inhalant allergens in the United States. With this insight, clinicians can differentiate between atopic and non atopic etiologies contributing to their patient’s symptoms; counsel their patients for allergic trigger avoidance; develop targeted exposure reduction action plans specifically tailored to each patient’s allergic sensitization profile; and prescribe the right medications.

David Esposito, President of Phadia US said, “The development of ImmunoCAP Rapid represents the continued evolution of Phadia’s leadership in in vitro allergy testing. With quick results available while the patient is still in the office, doctors will be able to help their patients better understand their allergic triggers which are common in respiratory diseases such as asthma and rhinitis.”

David Tinkelman, MD, Vice President of Health Initiatives at National Jewish Health, the #1 respiratory hospital in the US for the last 11 years, added, “By bringing allergy testing directly to the physician’s office, Phadia is providing physicians with new tools to improve patient care. These innovative new tests will help drive improvements in the assessment and management of patients, particularly those with asthma and other potentially allergic problems.” National Jewish Health, is collaborating with Phadia to develop educational programs addressing the importance of assessing the allergic state for patients with respiratory symptoms. ImmunoCAP Rapid is in line with the institution’s commitment to bringing advances in science and technology into their overall paradigm of care and personalized medicine.

ImmunoCAP Rapid represents an important addition to the ImmunoCAP Specific IgE blood test, the world leader and reference standard in allergy testing. ImmunoCAP Specific IgE was the first allergy test to be cleared by the FDA as a truly quantitative test for identifying allergen sensitization.

The European version of ImmunoCAP Rapid has been available in selected countries for over three years. Phadia US is preparing to market and sell ImmunoCAP Rapid to Physician Operated Laboratories that meet CLIA standards for Moderately Complex testing in the United States early this year.