AliveDx has secured IVDR-CE mark certification for its multiplexed MosaiQ AiPlex CD microarray immunoassay to improve the accuracy and speed of diagnosing celiac disease.
The MosaiQ AiPlex CD is designed to provide healthcare providers with a novel, unique solution to reduce the diagnostic delay, and burden of celiac disease testing.
It allows patients diagnosed with celiac disease to benefit from a Gluten-Free Diet (GFD) to reduce gastrointestinal symptoms and prevent long-term, severe health implications.
The microarray immunoassay comes with the most clinically relevant autoantibodies, tTG IgA, DGP IgA, tTG IgG and DGP IgG along with the detection of total IgA antibodies.
The company said it also provides complete diagnostic insights with a single sample and blood draw and helps laboratories automate and streamline the celiac disease diagnostic pathway.
AliveDx CEO Manuel Mendez said: “We are thrilled to obtain the CE mark for our MosaiQ AiPlex CD microarray.
“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.
“Early and accurate diagnosis is crucial for managing this condition. Our innovative MosaiQ microarray solutions represent a significant advancement to partner with laboratorians and clinicians to reduce healthcare costs and improve patient outcomes and quality of life.”
The MosaiQ AiPlex CD assay operates on the MosaiQ platform and offers a new approach to celiac disease testing by incorporating the most clinically relevant autoantibodies.
MosaiQ is a fully automated high-throughput platform that simplifies multiplex testing for autoimmune, allergy, and beyond.
The platform uses advanced microarray panels to rapidly detect and identify disease markers in up to 425 results per hour, to deliver rapid and accurate results.
According to AliveDx, the IVDR-CE mark approval indicates the MosaiQ AiPlex CD microarray assay meets the stringent IVDR standards set by the European Union (EU).
The approval ensures the assay is safe, effective, and ready for widespread clinical use in geographies that accept the CE mark certification.
In addition, the approval expands its impact across CE mark-accepting geographies, to improve the lives of those affected by celiac disease, said the medical technology company.
