Hycor Biomedical Applies CE Mark to IVD Allergy Instrument: NOVEOSTM (Credit: Hycor Biomedical)
Hycor Biomedical, a manufacturer of in vitro diagnostic products for allergy and autoimmune testing, announced that it has applied the CE mark to its allergy testing system, NOVEOS, along with an initial menu of Total IgE and over one hundred Specific IgE allergen reagents.
NOVEOS offers several breakthrough features including:
- Smaller sample requirements: Only 4µL of patient sample volume is required which can be especially important in pediatric and geriatric sampling where it may be more difficult to retrieve larger samples.
- True walk away capability: On-board reagents supply sufficient capacity for up to 8 hours of continuous testing. This eliminates the need to continuously replenish materials throughout a typical work day. It allows maximum walk away time for laboratory technicians by allowing up to 75 tests per specific allergen and up to 140 allergens on the system at any time.
- Use of standardized extracts: Many of the unrefined extracts that are used in skin-prick testing and competitive allergy assays generate less reliable patient results due to their complexity. As the allergen industry moves to more highly enriched or standardized extracts, the NOVEOS system has incorporated these materials to provide more consistent and accurate results.
“We are excited to bring NOVEOS to market in the EU,” said Dr. Fei Li, President and Chief Executive Officer 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.”
“A new lab testing option for allergies with these breakthrough features is very welcome in the medical community,” said Professor Harald Renz, Director and Chairman of Laboratory Medicine and Pathobiochemistry at Philipps University, Marburg, Germany and Past President of the German Society of Allergology and Clinical Immunology. “Specifically, the lower sample size requirement, which is 1/10th of the sample size required by most labs today, has the potential to redefine the experience for both pediatric and elderly patients and for labs.”
NOVEOS is Hycor’s latest allergy testing instrument to be introduced to the EU market. Hycor will be seeking 510(k) clearance from the Food and Drug Administration in the United States in the future.
