Hycor Biomedical, Garden Grove, Calif, has applied the CE mark to its Noveos allergy testing system, along with an initial menu of total immunoglobulin E (IgE) and more than 100 specific IgE allergen reagents.
Because the tests require only 4 µL of patient sample, they are suited for pediatric and geriatric sampling, where it may be more difficult to retrieve larger samples. Onboard reagents supply sufficient capacity for up to 8 hours of continuous testing. The system can support up to 75 tests per specific allergen and up to 140 allergens at any time. The system also uses standardized extracts to provide more consistent and accurate results.
“We are excited to bring Noveos to market in the European Union,” says Fei Li, MD, PhD, president and chief executive at Hycor. “These breakthrough features underscore Hycor’s commitment to drive immunodiagnostics into the future by offering the first new highly automated allergy platform technology in a generation.”
According to Hycor, the company has plans to seek FDA premarket notification (510(k)) clearance.
For more information, visit Hycor Biomedical.