Dec. 20, 2018—Hycor Biomedical received FDA 510(k) clearance for its new allergy testing system, Noveos. Features of the system include a reduction in sample size (4 μL of serum per test), reduced blood-based interferences, less variability within allergen lots, increased accuracy, and improved walkaway time, the company reports.
“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,” Fei Li, MD, PhD, president and CEO of Hycor, said in a press release. “The clearance of Noveos underscores our commitment to driving allergy immunodiagnostics into the 21st century for patients, laboratories, and physicians.”
Hycor also received clearance for the system’s first specific IgE assay to detect dust mite allergen and is focused on developing additional assays.