Mixed connective tissue disease

AliveDx receives three IVDR CE marks for its Multiplexed Autoimmune Diagnostics Solution

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星期一, 十月 30, 2023
SLE, Laboratory, Systemic scleroderma, Centromere protein B, Mixed connective tissue disease, Life, MCTD, IVDR, Centromere, CE, Connective tissue, Health, Inflammatory myopathy, Autoimmune disease, Hospital, Workflow, Syndrome, Algorithm, European, CTD, Diagnosis, Patient, CE marking, DNA, Medical device, Scleroderma

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.

Key Points: 
  • AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD)
    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 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.
  • "We are excited to receive the CE Mark for our initial clinical multiplexed microarrays.

AliveDx receives three IVDR CE marks for its Multiplexed Autoimmune Diagnostics Solution

Retrieved on: 
星期一, 十月 30, 2023
SLE, Laboratory, Systemic scleroderma, Centromere protein B, Mixed connective tissue disease, Life, MCTD, IVDR, Centromere, CE, Connective tissue, Health, Inflammatory myopathy, Autoimmune disease, Hospital, Workflow, Syndrome, Algorithm, European, CTD, Diagnosis, Patient, CE marking, DNA, Medical device, Scleroderma

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.

Key Points: 
  • AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD)
    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 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.
  • "We are excited to receive the CE Mark for our initial clinical multiplexed microarrays.

New real-world study demonstrates connection between Long COVID and rheumatic autoimmune disease symptoms and environmental triggers

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星期五, 十一月 11, 2022
Digital health, ACR, Health, Woman, Sleep, Rheumatology, Biomarker, Digital, COVID-19, PROMIS, Program, Pain, Mixed connective tissue disease, Movement, Institute, Ginger, JAK, Fatigue, Degenerative disease, Research, Solution, Quality of life, Ankylosing spondylitis, Food, American College of Rheumatology, Newsfirst Platinum Awards, Quality of life (healthcare), RCT, Precision medicine, Fast Company, Patient, Psoriatic arthritis, Medical director, Environment, SLE, Joint, MS, Brain, American College, Diet, ACHES, Institute for Clinical and Economic Review, ICER, COVID, Rheumatoid arthritis, Fasting, Time, Probiotic, Anxiety, Pharmaceutical industry, Medical device, Medical imaging, Lupus

NEW YORK, Nov. 11, 2022  /PRNewswire/ -- Mymee, Inc., a pioneer in self-evidence-based research for people who struggle with symptoms associated with long COVID and rheumatic autoimmune diseases, announced the completion of a multi-year retrospective study designed to assess the program's impact on health-related quality of life (HRQoL) and the use of personal data to identify unique sensitivities to hidden triggers within their food and environment. The majority of patients in the study were diagnosed with Lupus (SLE), Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Mixed Connective Tissue Disease or Long COVID.

Key Points: 
  • The majority of patients in the study were diagnosed with Lupus (SLE), Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Mixed Connective Tissue Disease or Long COVID.
  • The retrospective study also included an audited value impact sub-analysis of patients taking biologic disease modifying anti-rheumatic therapies.
  • Each patient was provided a dedicated certified health and nutrition coach with intensive training on Mymee's data platform and the special needs of rheumatic autoimmune disease and Long COVID patients managing debilitating symptoms.
  • Improvements included substantial decreases in fatigue, one of the most common and hardest to treat symptoms associated with rheumatic autoimmune disease and long COVID.

Quotient Limited and Theradiag Announce Partnership to Advance Autoimmune Disease Diagnostics

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星期三, 六月 8, 2022
Company, Infection, Inflammation, Blood, Drug resistance, US FDA, Brain, Technology, COVID-19, Autoimmune disease, Connective tissue, Joint, U.S. Securities and Exchange Commission, Degenerative disease, Marketing, ANA, IVD, Partnership, Fever, Mixed connective tissue disease, Solution, Lupus, Laboratory, Blood transfusion, Securities Exchange Act of 1934, Arthralgia, Diagnosis, Securities Act of 1933, Heart, Security (finance), Algorithm, Patient, Disease, EU, Incidence, Neutralizing antibody, Skin, Private Securities Litigation Reform Act, ENA, Fatigue, Drug Quality and Security Act, SLE, News, Medicine, Autoimmunity, Growth, ISIN, GLOBE, NASDAQ, CTD, Vaccine, Medical device, Medical imaging, Kerosene, Quotient

Under the new agreement, Theradiag will supply Quotient with autoimmune reagents and multi-constituent quality controls, for the development of autoimmune microarrays to be used on the MosaiQ solution.

Key Points: 
  • Under the new agreement, Theradiag will supply Quotient with autoimmune reagents and multi-constituent quality controls, for the development of autoimmune microarrays to be used on the MosaiQ solution.
  • Quotient estimates that autoimmune diagnostics would provide an additional $2 billion addressable market opportunity for Quotients MosaiQ platform.
  • The Quotient logo, Quotient MosaiQ and MosaiQ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
  • The Quotient logo, Quotient MosaiQ and MosaiQ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

aTyr Pharma and its Hong Kong Subsidiary, Pangu BioPharma, Announce Positive Data from a Phase 1b/2a Clinical Trial Demonstrating Consistent Dose Response of ATYR1923 in Pulmonary Sarcoidosis

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星期一, 九月 13, 2021
Oxygen, Idiopathic pulmonary fibrosis, Tony F. Chan, Biology, Biomarker, Food, Science, ATyr Pharma, HKUST, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, University, Global Vision, Forward-looking statement, Immune system, LIFE, Inflammation, Patient, Humanities, Scripps Research, Company, Private Securities Litigation Reform Act, Molecular medicine, Sarcoidosis, Risk, Fibrosis, RNA transfection, Founder, Granuloma, Annual report, Safety, Prognosis, ILD, Hong Kong University of Science and Technology, Death, IPF, HKT, COVID-19, Interstitial lung disease, Interest, Mixed connective tissue disease, GLOBE, HARS, Scar, FC, Research Assessment Exercise, Lung, SEC, Research, Neuropilin, Goal, Effectiveness, Pharmaceutical industry, Medicine

HONG KONG, Sept. 13, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or “The Company”), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, and the company’s Hong Kong subsidiary, Pangu BioPharma Limited (Pangu), which supports basic and translational research in tRNA synthetase biology in collaboration with the Hong Kong University of Science and Technology (HKUST), today announced positive results from the Company’s Phase 1b/2a double-blind, placebo-controlled clinical trial of its lead therapeutic candidate, ATYR1923, in 37 patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). ATYR1923 was safe and well-tolerated at all doses with no drug-related serious adverse events or signal of immunogenicity. Additionally, the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.

Key Points: 
  • ATYR1923 is a fusion protein comprised of this domain fused to the FC region of a human antibody.
  • We are very pleased to be a part of this groundbreaking work for ATYR1923, which represents the first clinical proof-of-concept for a tRNA synthetase derived therapy.
  • We look forward to the next steps for the ATYR1923 clinical program and the potential of this novel therapeutic to improve patient outcomes in patients with pulmonary sarcoidosis.
  • The Phase 1b/2a study was a randomized, double-blind, placebo-controlled, multiple-ascending dose clinical trial in 37 patients with pulmonary sarcoidosis.

aTyr Pharma Announces Positive Data from Phase 1b/2a Clinical Trial Demonstrating Consistent Dose Response for ATYR1923 in Pulmonary Sarcoidosis

Retrieved on: 
星期一, 九月 13, 2021
Oxygen, Idiopathic pulmonary fibrosis, ATyr Pharma, Pulmonology, Patient, Sarcoidosis, Granuloma, Prognosis, Interstitial lung disease, Department, Tumor necrosis factor, Research, Biology, Biomarker, Forward-looking statement, IP-10, Private Securities Litigation Reform Act, Fatigue, Southwest General Health Center, Annual report, ILD, Toxicity, IPF, COVID-19, Mixed connective tissue disease, GLOBE, Scar, IFN, Food, Neuropilin, ACE, Lung, SAA, Safety, Death, Interest, Goal, SEC, Effectiveness, Breathe Me, Cleveland Clinic, Quality of life, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, University, Steroid, LIFE, Inflammation, FVC, Risk, Fibrosis, RNA transfection, Disease, Cough, Population, FC, Vital capacity, Medical imaging, Dietary supplement, Pharmaceutical industry, Mineral wool

SAN DIEGO, Sept. 13, 2021 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced positive results from its Phase 1b/2a double-blind, placebo-controlled clinical trial of its lead therapeutic candidate, ATYR1923, in 37 patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). ATYR1923 was safe and well-tolerated at all doses with no drug-related serious adverse events or signal of immunogenicity. Additionally, the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.

Key Points: 
  • Additionally, the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.
  • The dose response and consistent response seen across multiple efficacy measures, without added toxicity, in this patient population with advanced disease is notable.
  • The dose response and consistent results across almost every endpoint are remarkable findings, and as good as could be expected in this small study.
  • aTyr Pharma will host a conference call and webcast to discuss the results today, September 13th at 8:30am ET/5:30am PT.

FDA Clears Thermo Scientific EliA SmD(P)-S Test For Use In U.S.

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星期四, 八月 26, 2021
Nephritis, Laboratory, Arginine, Elia, Mindful Scientific Inc., Patheon, Pharmaceutical Services Negotiating Committee, Diagnosis, Thermo Fisher Scientific, Science, Serology, Research, Mixed connective tissue disease, Arthritis, LINK, Invitrogen, SLE, Antibody, Lupus, Degenerative disease, Applied Biosystems, Use, Patient, Fisher Scientific, CLIN, Medical laboratory, FDA, Mayo Clinic College of Medicine and Science, Medical device, Fine chemical

PORTAGE,Mich., Aug. 26, 2021 /PRNewswire/ --Thermo Scientific EliA SmDP-S test has been cleared by the U.S. Food & Drug Administration (FDA) for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus.

Key Points: 
  • PORTAGE,Mich., Aug. 26, 2021 /PRNewswire/ --Thermo Scientific EliA SmDP-S test has been cleared by the U.S. Food & Drug Administration (FDA) for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus.
  • This new test enhances specificity without sacrificing sensitivity, leading to a more precise diagnosis while also reducing the number of false positives1.
  • With the new EliA SmDP-S assay, clinicians can have greater confidence for differentiating SLE from mixed connective tissue disease, because of the improved immuno-chemical specificity.
  • For more information on the Thermo Scientific EliA SmDP-S test, please visit https://www.thermofisher.com/phadia
    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion.