AliveDx secures IVDR CE marks for three MosaiQ multiplexed assays
31 Oct 2023
ImmunotherapyDiagnostic Reagents
AliveDx has received the CE Marks for its automated, multiplexed MosaiQ CENP-B microarray immunoassay, MosaiQ AiPlex CTD microarray immunoassay, and multiconstituent MosaiQ AiPlex CTD Quality Controls
The close-up image of the microarray. (Credit: AliveDx)
AliveDx, previously known as Quotient, has received CE mark approvals for three of its automated and multiplexed MosaiQ solutions, under the European Union’s (EU) In-Vitro Diagnostic Regulation (IVDR).
The company’s MosaiQ Centromere Protein B (CENP-B) microarray, MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassay, and its MosaiQ AiPlex CTD Quality Controls have been granted the CE mark.
Its MosaiQ solutions include a fully automated, high throughput instrument platform, unique planar multiplexed microarray technology, and a smart image analysis algorithm.
The CE mark of the MosaiQ tests will enable rapid diagnosis of Connective Tissue Diseases (CTD) in the EU and other geographies that recognise the CE mark.
It allows the company to provide laboratories and hospitals with in-vitro diagnostics solutions that improve workflow and faster turnaround time to diagnose and treat autoimmune diseases.
AliveDx CEO Manuel Méndez said: “This approval confirms the MosaiQ solution flexibility to address various disease areas and simplify testing algorithms. I am thankful and proud of the AliveDx team and partners for achieving this milestone.
“We look forward to expanding our portfolio in the near future. We are committed to empowering diagnostic insights, transforming patient care, and innovating for life.”
The MosaiQ AiPlex CTD microarray immunoassay is designed to detect auto-antibodies to native, double-stranded DNA, Sm, U1RNP, SS-A (Ro-60), Trim-21 (Ro-52), SS-B, SCL-70, Jo-1, Sm/RNP, Centromere Protein B and Ribosomal P.
It aids diagnosis of multiple CTD, including Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome, Scleroderma, Polymyositis, and Mixed Connective Tissue Disease (MCTD).
The MosaiQ CENP-B microarray immunoassay is designed for the detection of auto-antibodies to only Centromere Protein B.
The MosaiQ CENP-B and AiPlex CTD immunoassays are intended for use on AliveDx’s fully automated high-throughput MosaiQ microarray platform.
Last year, AliveDx secured the CE mark for its MosaiQ Extended Immunohematology (IH) Microarray, which improves workflow and reduces costs for laboratories and clinicians.
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