NEW YORK — Swiss diagnostics company AliveDx said Monday that it has received IVDR CE marking for its microarray-based immunoassay for allergy diagnosis.
The test runs on the company's automated high-throughput MosaiQ platform and is designed to detect specific immunoglobulins E to a range of protein allergens in a single blood sample, according to AliveDx.
"This comprehensive approach will help optimize laboratory workflows and help clinicians obtain a complete picture of their patient's atopic sensitization profile," AliveDx Chief Scientific and Medical Officer Christian Fischer said in a statement.
In late 2023, AliveDx — formerly named Quotient — received CE markings for two multiplexed microarray immunoassays used to aid diagnosis of connective tissue diseases. Around that same time, the firm gained IVDR certification for its in vitro diagnostics manufacturing sites in Eysins, Switzerland, and Edinburgh, UK.