Swiss diagnostics company AliveDx has received the CE mark for its microarray immunoassay to evaluate allergies, under the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR).
The immunoassay is designed to run on the company’s MosaiQ platform to detect a specific Immunoglobulin E (IgE) antibody directed to a protein allergen in human serum.
It is said to be the company’s first diagnostic product for the evaluation of allergies and is expected to extend its product portfolio beyond autoimmunity.
AliveDx said that the immunoassay supports its current development of multiplex immunoassay microarray to detect over 30 allergens, including inhalant and food allergens.
Its multiplex immunoassay microarray technology advances diagnostics by enabling simultaneous testing for multiple conditions.
The approach simplifies the identification, simplifies laboratory workflows, and reduces the hands-on time required with singleplex methods.
Its immunoassay microarray technology allows both laboratories and clinicians to detect and rule out various conditions while saving time, said the diagnostics company.
AliveDx chief scientific and medical officer Christian Fischer said: “The new multiplex immunoassay will provide a detailed analysis of an individual’s allergic sensitisation 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 sensitisation profile.”
MosaiQ is a fully automated high-throughput platform that simplifies multiplex testing for autoimmune diseases, allergies, and other conditions.
The platform was already granted the CE mark approval for autoimmune disease screening.
It leverages advanced microarray panels to rapidly detect and identify disease markers while maximising workflow efficiencies, simplifying pathways, and helping shorten the diagnosis time.
AliveDx said the first CE mark in the Allergy category will allow the expansion of its MosaiQ offering and support people suffering from allergies.
Furthermore, the Swiss diagnostic company intends to expand its panels in allergy and autoimmune sectors in the coming months and partner with distributors worldwide.
AliveDx CEO Manuel Méndez said: “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.”
