Press Release: Phadia - New POC allergy test has been cleared by FDA

The US medical agency FDA has today granted Phadia, the world leading company within allergy diagnostics with headquarters in Uppsala Sweden, the clearance to sell and market its new POC allergy test ImmunoCAP® Rapid product in US.

- "This is a historical event in the diagnostic industry since it is the first semi-quantitative POC allergy test that has been FDA cleared. It is a major milestone for Phadia in building the ImmunoCAP franchise even stronger and will provide more patients with allergy-like symptoms the possibility to get a correct diagnosis" says Håkan Englund, Executive Vice President Phadia AB.

ImmunoCAP Rapid is designed for use in decentralised settings and can provide a fast result within 20 minutes, providing an allergy diagnosis, at the first physician visit.

ImmunoCAP Rapid is very simple to use. It requires only a small blood sample taken from the finger to aid the diagnosis "allergy or not". The test result will provide an answer if the patient is allergic to any of the ten most common inhalant allergens such as house-dust mite.

ImmunoCAP Rapid will be introduced on the US market later in the year.

The European versions of the ImmunoCAP product have since 3 years back been marketed and sold in selected European countries.

For more information contact:

Håkan Englund, EVP Phadia AB, +46-18-165226 or +46-70-5165226

For more information about Phadia

As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.