CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
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.”