NOVEOS, a New Allergen Detection Technology, Now FDA Cleared

HYCOR, a company based in Garden Grove, California, won FDA clearance to introduce its NOVEOS allergy testing system in the United States.

The NOVEOS uses microparticles and chemiluminescence, with help from liquid ready-to-go reagent, to provide accurate results using small sample sizes. HYCOR believes that its system is resistant to blood-based interferences, is more consistent within allergen lots, and doesn’t require as much baby-sitting by lab techs as existing products.

In addition to clearing the system, the FDA gave the go-ahead to HYCOR’s Specific IgE (sIgE) assay to detect Dust Mite allergen (D001). More assays in development and the company promises to provide a comprehensive list of options.

“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,” in a published statement said Robert G. Hamilton, Ph.D., D.ABMLI, Professor of Medicine and Pathology at Johns Hopkins University School of Medicine.

Product page: NOVEOS…

Via: Hycor Biomedical…

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