NEW YORK – AliveDx said Tuesday that it has received CE-IVDR marking for a blood-based immunoassay to aid the diagnosis of celiac disease.
The Swiss diagnostic firm's MosaiQ AiPlex CD microarray immunoassay is a multiplex test that is used for the detection of autoantibodies including tTG IgA, DGP IgA, tTG IgG, and DGP IgG as well as total IgA antibodies. The test is designed for use on the company's fully automated high-throughput MosaiQ System.
The MosaiQ platform uses microarray panels for the rapid detection and identification of disease markers with up to 425 results per hour.
The firm noted that patients with celiac disease have an abnormal immune response to the consumption of gluten including autoantibody production and small bowel damage. Diagnosis typically involves serological testing for autoantibodies and considering the results along with imaging, genetic, and histopathological findings.
The company noted that clinical guidelines recommend testing for IgA autoantibodies against tissue transglutaminase (anti-tTG IgA) and deamidated gliadin peptides (anti-DGP IgA). Measuring total IgA concentrations is recommended along with testing for autoantibodies because some patients may have selective IgA deficiency, for which testing for IgG autoantibodies is recommended.
AliveDx said it expects to significantly expand its MosaiQ autoimmune and allergy testing portfolio in 2025 and subsequent years.
"The MosaiQ fast portfolio expansion marks our fourth microarray CE-mark approval in the last 12 months, reflecting our dedication to rapidly advance diagnostic technologies and our commitment to support the millions of individuals affected by autoimmune diseases," AliveDx CEO Manuel Mendez said in a statement.
The company also said in July that it received CE-IVDR marking for a microarray-based immunoassay to aid allergy diagnosis.