Phadia wins FDA clearance for new allergy test

Phadia, an in vitro allergy diagnostics company, has received the FDA clearance for its ImmunoCAP Rapid, the first point-of-care test to assist in the diagnosis of allergy in the physician’s office.

According to Phadia, ImmunoCAP Rapid is the next evolution of the 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.

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 US in 2009 later.

Michael Land, president of Phadia US, said: 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.

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.