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BREAKTHROUGH ALLERGY TESTING DEVICE RECEIVES FDA APPROVAL

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BREAKTHROUGH ALLERGY TESTING DEVICE RECEIVES FDA APPROVAL

Allergies are an ever-increasing issue for people across the world. The potential health risks associated with them as well as adoptions of lifestyle options to manage such conditions, means that having an allergy can be inhibitive, and in extreme cases, fatal.

With that in mind, new technologies are needed to assess what it is that people are allergic to, in order to prescribe necessary medications and prevent unwanted reactions from occurring.

California based company HYCOR received FDA approval for its NOVEOS  allergy testing system. Described as a breakthrough, it uses microparticles and chemiluminescence with assistance from liquid ready-to-go reagent to give precise outcomes. Clinicians can go forth to manage patients efficiently, therefore.

The samples needed for testing using this device are only small and HYCOR has faith that NOVEOS™ is impervious to blood-based interferences. Additionally, the system is consistent with allergen lots and does not need as much intervention from laboratory technicians, in comparison to other systems on the market; a cost-saving benefit.

NOVEOS™ was awarded FDA approval towards the end of 2018. In addition to this, the FDA awarded HYCOR endorsement for its Specific IgE (sIgE) assay for detecting Dust Mite allergens (D001). HYCOR is working on the development of further assays and has pledged to offer a broad range of options.

Robert G. Hamilton, Ph.D., D.ABMLI, Professor of Medicine and Pathology at Johns Hopkins University School of Medicine said:

“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,”

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