Microarray immunoassay in allergy diagnostics obtains IVDR CE marking: AliveDx

AliveDx, a global in vitro diagnostics company, has received IVDR CE mark certification for its groundbreaking microarray immunoassay, designed to detect specific IgE antibodies to protein allergens in human serum. This marks AliveDx’s first product in allergy diagnostics, expanding its portfolio beyond autoimmunity.

Developed on the MosaiQ platform, the immunoassay is a significant step toward AliveDx’s multiplex immunoassay microarray, which will eventually detect over 30 allergens, including inhalant and food allergens. This technology enhances diagnostic efficiency by enabling simultaneous testing of multiple conditions, streamlining workflows, and reducing time compared to traditional singleplex methods. It allows for quicker, more accurate diagnoses and targeted treatment for patients with multiple allergies.

The MosaiQ platform, already CE marked for autoimmune disease screening, now extends to allergy testing, underscoring AliveDx’s commitment to advancing diagnostic solutions and expanding its offerings globally.