Hycor Biomedical Receives FDA 510(k) Clearance for NOVEOS™, Its Modern Allergy Testing Instrument

GARDEN GROVE,California,Dec. 19,2018 --Hycor Biomedical,a leading manufacturer of in vitro diagnostic products for allergy and autoimmune testing,announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new allergy testing system,NOVEOS.

NOVEOS

"Hycor has a long history of being at the forefront of allergy diagnostic testing and we developed NOVEOS to be a paradigm-changing diagnostic system for laboratorians with limited options in the allergy space," said Dr. Fei Li,President and Chief Executive Officer at Hycor. "The clearance of NOVEOS underscores our commitment to driving allergy immunodiagnostics into the 21st century for patients,laboratories and physicians."

Employing microparticles,chemiluminescence and liquid ready-to-use reagent,NOVEOS provides the first-of-its-kind technology to be introduced for routine allergy testing labs in over 20 years. The system was designed to address common issues laboratorians face with current technologies by offering several innovative features,including a significant reduction in sample size,reduced blood-based interferences,less variability within allergen lots,increased accuracyand improved walk-away time for laboratory technicians.

The company also received simultaneous clearance for the system's first Specific IgE (sIgE) assay to detect Dust Mite allergen (D001),and is focused on the development of additional assays to provide a comprehensive menu to customers.

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

About Hycor Biomedical

Founded in 1981,Hycor is a global manufacturer and marketer of in vitro diagnostics products. Since its founding,Hycor has expanded its presence into allergy and autoimmune products used in clinical laboratories,hospitals and doctors' offices worldwide. Among its products,Hycor markets the HYTEC® and AUTOSTAT® brands and recently added the NOVEOS product line,which recently received CE mark in the European Union and FDA clearance in the United States. The company is focused on delivering quality products that provide the highest value to clinicians through innovation,reliability and customer service. For more information,please visit www.HYCORbiomedical.com.

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