Phadia announces the recent United States Food and Drug Administration clearance of ImmunoCAP® Rapid, the first point-of-care test to assist in the diagnosis of allergy in the physician’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,” states 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, a proven, valuable tool for clinicians, measures Immunoglobulin E (IgE) antibodies to indoor, outdoor, and food allergens in a small sample of blood. Specific IgE is produced as a result of sensitization to a specific allergen and increases with exposure to that substance. 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 the next evolution of the proven ImmunoCAP technology and 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 US.
These results are available in just 20 minutes, allowing the physician to quickly make evidence-based decisions. In addition, this timeframe will allow the physician and patient to discuss appropriate treatments, including targeted exposure reduction, while the patient is still in the office.
National Jewish Health, the #1 respiratory hospital in the US for the last 11 years, is collaborating with Phadia to build an educational program and website 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.
“This technology will bring rapid results of allergy testing to the offices of Pulmonologists to help in the assessment and management of their patients, particularly those with asthma and other potentially allergic problems. It should significantly advance their ability to care for their patients, ”said David Tinkelman, MD, Vice President of Health Initiatives at National Jewish Health.
The European version of ImmunoCAP Rapid has been available in selected countries for over two years. Phadia US is preparing to market and sell ImmunoCAP Rapid to the medical community in the United States later this year.
