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.”