AliveDx (“Company”) is proud to announce it has received IVDR CE mark for its groundbreaking microarray immunoassay, designed for the detection of a specific IgE directed to a protein allergen in human serum. This is the Company’s first product for the evaluation of allergies, enhancing its portfolio of products beyond autoimmunity.
This immunoassay, run on AliveDx’s proprietary MosaiQ® platform, is an important milestone for the current development of the Company’s multiplex immunoassay microarray, which aims to simultaneously detect 30+ allergens, including inhalant and food allergens.
The multiplex immunoassay microarray technology marks a significant advancement in diagnostics by enabling simultaneous testing for multiple conditions. This approach streamlines the identification process, simplifies laboratory workflows, and reduces the hands-on time required with singleplex methods. As a result, both laboratories and clinicians save valuable time and can detect and rule out various conditions more efficiently. For patients sensitized to multiple allergens (polysensitized), this technology targets a fast, thorough diagnosis and more targeted treatment.
“The new multiplex immunoassay will provide a detailed analysis of an individual’s allergic sensitization by testing specific IgE to a wide array of allergens in a single test. This comprehensive approach will help optimize laboratory workflows, and help clinicians obtain a complete picture of their patient’s atopic sensitization profile,” said Christian Fischer, Chief Scientific & Medical Officer at AliveDx.
The MosaiQ platform is already CE marked for autoimmune disease screening. Receiving a first IVDR CE mark in the Allergy category reaffirms AliveDx’s dedication to expanding its MosaiQ® offering and aiding the millions of people worldwide who suffer from allergies.
This milestone highlights the Company’s commitment to establishing itself as a key player in both the Allergy and Autoimmune sectors. It also underscores the flexibility and versatility of the MosaiQ platform. AliveDx anticipates expanding its panels in both segments in the coming months and partnering with distributors throughout the world.
“This is a memorable moment in the history of AliveDx. Patients will soon be able to receive results for multiple allergens from a single blood sample, reducing the need for multiple tests and visits. For the medical community, this means having access to an efficient and cost-effective solution, which consolidates multiple tests into one. We look forward to supporting patients around the world, and helping them get appropriate treatment sooner,” said Manuel O. Méndez, CEO of AliveDx.
