AliveDx has obtained the European In Vitro Diagnostic Device Regulation (IVDR) CE mark for its microarray immunoassay in allergy diagnostics.
The assay, which detects specific IgE directed to protein allergens in human serum, represents the company’s first foray into the allergy evaluation market.
It operates on AliveDx’s MosaiQ platform and is a critical step in the development of the company’s multiplex immunoassay microarray.
The microarray is designed to simultaneously test for more than 30 allergens, including both inhalant and food allergens, offering a comprehensive diagnostic solution.
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The multiplex immunoassay microarray technology also allows for the concurrent testing of multiple conditions.
This helps streamline the diagnostic process, simplify laboratory operations, and reduce the time spent on traditional singleplex methods.
The efficiency gains from this technology are significant for both laboratories and healthcare providers, enabling quicker and more comprehensive condition detection and exclusion.
For patients with polysensitivities, the technology offers expedited and more precise diagnoses.
The MosaiQ platform, which already holds a CE mark for autoimmune disease screening, has now expanded its certification to include allergy diagnostics.
Looking ahead, AliveDx plans to broaden its diagnostic panels in both autoimmunity and allergy segments.
The company is seeking distribution partnerships worldwide to bring its solutions to a global audience.
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 optimise laboratory workflows, and help clinicians obtain a complete picture of their patient’s atopic sensitisation profile.”
