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Hycor Biomedical Wins FDA Clearance for Allergy Testing System

NEW YORK (360Dx) — Hycor Biomedical said today that it has received 510(k) clearance from the US Food and Drug Administration for its Noveos allergy testing system and a related assay for dust mite allergen detection.

According to Garden Grove, California-based Hycor, Noveos is a chemiluminescent-based system with a menu of over 100 specific immunoglobulin E tests,  including the newly cleared dust mite allergen test. Each test requires only 4 microliters of serum. The system — which is capable of up to 700 tests per run over an eight hour period — received CE marking earlier this year.

"This new microbead-based IgE antibody assay technology looks promising as a novel diagnostic testing option with a unique small sample size requirement for identifying sensitization in patients suspected of having allergic disease," Johns Hopkins University School of Medicine researcher Robert Hamilton said in a statement.