CENPB

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.

AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD) - The MosaiQ CENP-B microarray immunoassay designed for the detection of Auto-antibodies to Centromere Protein B - The MosaiQ AiPlex CTD microarray immunoassay designed as an aid in diagnosis of Connective Tissue Diseases - The multiconstituent MosaiQ AiPlex CTD Quality Controls EYSINS, Switzerland, Oct. 30, 2023 /PRNewswire/ -- AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray, its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its MosaiQ AiPlex CTD Quality Controls. By launching its Autoimmune testing portfolio in the European Union and other CE Mark recognizing geographies, the company is providing laboratories and hospitals with a novel in-vitro diagnostics solution to enable improved workflow and faster time to diagnosis and treatment of patients suffering from Autoimmune diseases. The company is pursuing an ambitious plan to rapidly expand its clinical immunology portfolio. The MosaiQ solution combines a fully automated, ease to use, high throughput instrument platform, proprietary planar multiplexed microarray technology, and a smart image analysis algorithm to enable faster turn-around times for complex diagnostics pathways. Economic and Clinical Value through multiplexed testing with MosaiQ AiPlex CTD microarray The new CE-Marked 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. Hence it aids in the diagnosis of multiple Connective Tissue Diseases, including Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome, Scleroderma (Systemic Sclerosis, SSc), Polymyositis/Dermatomyositis, and Mixed Connective Tissue Disease (MCTD). "We are excited to receive the CE Mark for our initial clinical multiplexed microarrays. 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," said Manuel O. Méndez, Chief Executive Officer of AliveDx. Follow us on LinkedIn and X or visit for more information. About AliveDx At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster disease detection to shorten the time to diagnosis. Alba – our blood bank reagents portfolio – and MosaiQ® – one of the first multiplexing and multimodality automated testing platforms – are designed to make laboratories more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life. ©AliveDx Holdings Finance Company Ltd, 2023. MosaiQ is a trademark or registered trademark of AliveDx Holdings Finance Company Limited or its subsidiaries in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories. Subject to regulatory clearance. SOURCE AliveDx