Mixed Connective Tissue Disease

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

Personalized trials help patients achieve major reductions in joint flares and concomitant Rx in 17 weeks, while delivering $11k average autoimmune biologic and targeted therapy savings per non-responder annually. NEW YORK, June 1, 2023 /PRNewswire/ -- Today Mymee Inc, a pioneer in personalized trials & care for patients with uncontrolled autoimmune and long COVID disease flares, announced new peer-reviewed and payer-audited research that sheds light on the enormous challenges facing autoimmune patients with joint flares, >30 moderate to high frequency symptoms, and inadequate response to pharmacological treatments. Continue Reading Of the 163 rheumatic patients in the personalized trial study, 73% had comorbidities and the majority were diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lupus (SLE), MCTD, long COVID, psoriasis and IBD. 77% of patients were referred by payers and providers including Preferred One (UHC), Nielsen/WTW and Mount Sinai Hospital. Average autoimmune biologic and targeted therapy reductions reported in the study were validated through an independent analysis by a commercial insurer. The savings were based on current list prices (WAC) before rebates. Findings explain why rheumatic patients are successfully able to reverse flares through personalized trials and care. Tweet this Findings explain why rheumatic patients are successfully able to reverse flares, improve quality of life and reduce medication through personalized trials & care, after evidence-based treatments and trial & error between alternative solutions fail them. Presented today at the annual IFM medical conference "Advances in Clinical Research and Innovative Practices", this research involved 121,852 patient-reported data captures and 3,391 personalized trial coach sessions delivered over an average 17 weeks. The data presented confirm: 70% of patients with moderate to severe flares as measured by 10 PROMIS® HRQoL reversed their level of severity within 17 weeks. Mean reduction in moderate to high frequency symptoms, e.g.: joint pain (33%); fatigue (33%); limitation of movement (39%); muscle pain (40%); anxiety (41%); weakness (42%) Patients reported working directly with their physicians to reduce 31% of immunotherapies, or 24% of biologics and DMARDs. Non-adherence to therapy was not a driver of disease flares, with 5 average medications per patient at baseline (76% ≥ 1 immunosuppressant). Patients cited 98% improvement in ability to work with physicians to manage symptoms. A critical objective of the peer-reviewed study was to demonstrate the complexity that non-responders face when trying to control flares with a trial & error approach based on standard drug, supplement, nutrition & health guidelines. The visual in the peer-reviewed study highlights this complexity, showing the unique associations between diverse symptoms and combinations of exposome variables (food, drugs, supplements, excipients, allergens, pathogens, stresses, climate, etc). More than 225 symptoms and 534 triggers were tracked in patients' own words for observation and tested across the personalized trials, with correlations confirmed when modification reliably worsened or improved symptom response. Dr. Kurt Herzer, Adjunct Professor at Johns Hopkins University and former Head of Population Health at Oscar Health, said, "Mymee's novel personalized trial & care research provides evidence that it is possible to develop new models addressing the challenges at-risk autoimmune patients face as they seek to control their flares, particularly those who are non-responders to standard therapies. It is clear industry stakeholders should take steps to improve the standard of care for this overlooked patient population." Autoimmune drugs cost $100 billion annually, comprising 20% of total US drug costs and 54% of specialty pharmaceutical growth, attributable to only 1% of health plan members. The bigger challenge is that >65% of rheumatic patients have inadequate response to autoimmune drugs in the real world as measured by Rx and healthcare claims data. 44% of rheumatic patients face reduction or inability to work, as reported by the American College of Rheumatology 2020 Survey. These patients remain at risk of persistent, unpredictable disease flares due to unique sensitivities to their exposome. Mymee CEO & Founder, Mette Dyhrberg said, "The great hope is one day all will have access to a therapy that allows for sustained remission for a lifetime. In the interim, this study demonstrates it's possible for personalized trials & care to help patients gain control of their flares and reclaim their health, when the standard of care fails them." About Mymee Mymee Inc is a pioneer in personalized trials & care for patients with uncontrolled autoimmune and long COVID disease flares. Mymee's proprietary personalized trial & care platform is clinically validated and SOC-II and HIPAA-compliant. In peer-reviewed studies, Mymee delivered statistically significant improvements in all ten HRQoL PROMIS® domains and a >40% mean reduction in 59 patient-reported symptoms. Peer-reviewed publications include Rheumatic & Musculoskeletal Disease Open Journal ('23), IFM Conf ('23 & '20), ACR Conf ('22), JMIR Lupus (SLE) Publication ('20) and IEEE conf ('20). Mymee has received industry recognition including Top 100 NY Healthcare Startups 2022 & 2023, Health 2.0 Outstanding Leadership Award: CEO & Founder 2022, Juniper Networks Awards 2022: #1 Most Innovative Precision Medicine Solution, Nominee Prix Galien Award: Digital Health, 2021, Honoree Fast Company World Changing Ideas Awards 2021. To learn more about how Mymee is transforming autoimmune care, visit or follow us on Twitter @mymeehealth. SOURCE Mymee Inc.