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Clearance for Quidel's QuickVue allergy test:

This article was originally published in Clinica

Executive Summary

Quidel (US) has gained FDA market clearance for its QuickVue One-Step Allergen Screen, which distinguishes allergy symptoms such as rhinitis, wheezing, hives and skin rashes from viral or bacterial infections such as colds and 'flu. Performed using a small blood sample from either a finger prick or venipuncture, it is claimed to be the first in-office, one-step allergy test to allow primary-care screening for five common indoor allergens in 15 minutes or less. Allergies affect around one in five Americans, accounting for 10% of all doctor's office visits, says Quidel. The worldwide in-vitro allergy testing market is estimated at $150 million.

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