Patients new to a rheumatology practice will be asked if they want to consent to their blood sample, medical records, and hand/foot x-rays (with sharp scores) for the analysis and correlation with the diagnosis they will receive from the rheumatologist.

Start Date15 Mar 2019

Sponsor / Collaborator

Arthritis Northwest PLLC

[+3]

100 Clinical Results associated with INOVA Diagnostics, Inc.

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148

Literatures (Medical) associated with INOVA Diagnostics, Inc.

24 Dec 2021·Rheumatology

Anti-RNPC-3 antibody predicts poor prognosis in patients with interstitial lung disease associated to systemic sclerosis

Article

Author: Beretta, Lorenzo ; Sanz-Martínez, Maria Teresa ; Fonollosa-Pla, Vicente ; Guillén-Del-Castillo, Alfredo ; Callejas-Moraga, Eduardo Luis ; Lorite-Gomez, Karen ; Bellocchi, Chiara ; Mahler, Michael ; Perurena-Prieto, Janire ; Severino, Adriana ; Simeón-Aznar, Carmen P

AbstractObjectiveTo analyse the prevalence, the clinical characteristics, the overall survival and the event-free survival (EFS) of SSc patients who express anti-U11/U12 RNP (RNPC-3) antibodies.MethodsA total of 447 SSc patients from Barcelona (n = 286) and Milan (n = 161) were selected. All samples were tested using a particle-based multi-analyte technology. We compared anti-RNPC-3 positive and negative patients. Epidemiological, clinical features and survival were analysed. End-stage lung disease (ESLD) was defined if the patient developed forced vital capacity <50% of predicted, needed oxygen therapy or lung transplantation. EFS was defined as the period of time free of either ESLD or death.ResultsNineteen of 447 (4.3%) patients had anti-RNPC-3 antibodies and interstitial lung disease (ILD) was more frequent (11, 57.9% vs 144, 33.6%, P =0.030) in individuals with anti-RNPC-3 antibodies. More patients reached ESLD in the positive group (7, 36.8% vs 74, 17.3%, P = 0.006), and a higher use of non-glucocorticoid immunosuppressive drugs was observed (11, 57.9% vs 130, 30.4%, P = 0.012). Anti-RNPC-3 positive patients had lower EFS, both in the total cohort (log-rank P =0.001), as well as in patients with ILD (log-rank P = 0.002). In multivariate Cox regression analysis, diffuse cutaneous subtype, age at onset, the presence of ILD or pulmonary arterial hypertension and the expression of anti-RNPC-3 positivity or anti-topo I were independently associated with worse EFS.ConclusionThe presence of anti-RNPC-3 was associated with higher frequency of ILD and either ESLD or death. These data suggest anti-RNPC-3 is an independent poor prognosis antibody in SSc, especially if ILD is also present.

31 Aug 2021·Clinical and Experimental RheumatologyQ3 · MEDICINE

Serum calprotectin (S100A8/9), clinical and ultrasound assessment in patients with juvenile idiopathic arthritis

Q3 · MEDICINE

Article

Author: Meroni, Pier Luigi ; Giani, Teresa ; Cimaz, Rolando ; Borghi, Maria Orietta ; Piskin, David ; Bodio, Caterina ; Romano, Micol ; Gerloni, Valeria ; Gattinara, Maurizio ; Mahler, Michael ; De Lucia, Orazio

OBJECTIVESTo explore the association between serum S100A8/9 (calprotectin), clinical and ultrasound (US) assessment in juvenile idiopathic arthritis (JIA) patients.METHODSA total of 30 well-characterised consecutive patients (18 female) with non-systemic JIA and 20 age-matched healthy controls were included. Serum and plasma samples obtained the same day of the clinical and sonographical assessment were tested for calprotectin levels by ELISA. Clinical status was defined using Wallace criteria. Ultrasonographic B-mode and power Doppler (PD) assessment of 44 joints for each subject was performed.RESULTSClinically active disease was present in 14 patients, while 16 patients were active according to US evaluation. We found no differences in the serum/plasma calprotectin levels in clinically active disease group [29.6 (5.4-198.1) ng/ml; 12.6 (2.8-65.8) ng/ml] as compared with inactive disease group [24.8 (14.1-204.3); 12.7 (3.4-65.1)] (p=0.73; p=0.29). There was also no difference between US active disease [29.8 (5.4-204.3); 12.9 (2.8-65.8)] and US inactive disease [24.8 (12.1-197.1); 11.7 (3.4-44.2)] with regard to the serum/plasma calprotectin levels (p=0.83; p=1.0). Serum/plasma calprotectin levels correlated moderately with C-reactive protein (CRP) (Spearman r=0.44, p=0.01; Spearman r=0.56, p=0.0021).CONCLUSIONSTo our knowledge, this is the first study to simultaneously examine the correlation between serum/plasma calprotectin levels, clinical and US assessment in JIA. Calprotectin was not associated with the disease status in JIA patients with low number of active joints and its levels were moderately correlated with CRP. Our preliminary study needs to be extended with a larger number of patients.

01 Jun 2021·Annals of the Rheumatic Diseases

POS0464 IS IT POSSIBLE TO IDENTIFY INDIVIDUALS AT IMMINENT-RISK OF SUB-CLINICAL JOINT INVOLVEMENT?

Author: L. Duquenne ; P. Emery ; L. Garcia-Montoya ; R. Wakefield ; A. Di Matteo ; K. Mankia ; J. Nam ; E. Cipolletta ; M. Mahler

Background:In anti-CCP antibody (Ab) positive at-risk individuals with MSK symptoms but without clinical synovitis, the detection of ultrasound (US) subclinical inflammation is associated with an increased risk of progression to inflammatory arthritis (IA) 1. Studies suggest that in these at-risk individuals, MSK symptoms develop before subclinical joint inflammation occurs on US. As such, anti-CCP Ab positive individuals with MSK symptoms in the absence of clinical or sub-clinical inflammation may be at the critical time-point for preventive treatments, before joint inflammation occurs and eventually becomes established (i.e., before the ‘second-hit’ in RA pathogenesis); however, identifying these individuals is challenging.Objectives:To identify, in second generation anti-CCP Ab (CCP2+) at-risk individuals with MSK symptoms, but without clinical or sub-clinical synovitis, predictors of US sub-clinical synovitis.Methods:In 186 CCP2+ at-risk individuals with normal baseline US scan (i.e., no synovitis or bone erosions), and a complete dataset, US data were analyzed at 6, 12 months, then annually until occurrence of IA. US synovitis was identified according to the EULAR/OMERACT definitions2. Relevant demographic (age and gender), clinical [early morning stiffness (EMS), tenderness in the small joints of the hands] and serological [anti-CCP2 Ab level, third generation anti-CCP Ab (CCP3) and rheumatoid factor (RF)] data were collected at baseline. Regression analyses, Kaplan-Meier analysis and Log-Rank test were performed.Results:US synovitis was detected in ≥1 longitudinal US scan in 69/186 (37.1%) at-risk individuals (median time to first developing US synovitis: 53 weeks, IQR 27.0-105.8; median number of joints with US synovitis: 2.0, IQR 1.0-2.0). As shown in Table 1, only anti-CCP3 Ab were significantly associated with development of US sub-clinical synovitis in the multi-variable analysis while borderline results were observed with age.

Table 1.Regression analyses for the development of US synovitis.Univariable analysisMultivariableanalysisOR (95% CI)p-valueOR (95% CI)p-valueGender (male)1.02 (0.52-2.02)0.95//Age1.03 (1.01-1.06)<0.011.03 (1.00-1.06)0.03Tenderness in the hands0.86 (0.46-1.61)0.64//EMS1.60 (0.87-2.95)0.13//Anti-CCP2 Ab (high titre)2.79 (1.37-5.67)<0.011.20 (0.50-2.89)0.69Anti-CCP3+4.44 (2.28-8.66)<0.013.30 (1.39-7.89)<0.01RF+2.96 (0.46-1.61)0.011.45 (0.68-3.11)0.33

CCP2+ individuals with positive anti-CCP3 Ab show a significantly reduced sub-clinical synovitis-free survival rate compared with individuals with negative anti-CCP3 Ab (Figure 1). At 1- and 2-year follow-up, respectively 23.3% and 38.3% of individuals with dual CCP2/CCP3 positivity developed sub-clinical synovitis on longitudinal scans, compared with 8.4% and 13.3% of CCP2+ individuals with negative anti-CCP3 Ab (p=0.01) (Figure 1a).

Similar results were observed in the subgroup of high level CCP2+ individuals. At 1- and 2-year follow-up, respectively 24.5% and 39.4% of high level CPP2/anti-CCP3+, but only 6.1% and 15.2% of CCP2+ individuals with negative anti-CCP3 developed sub-clinical synovitis on longitudinal scans (p<0.01) (Figure 1b).Figure 1.Kaplan-Meier analysis shows US sub-clinical synovitis free survival time in CCP2+ at-risk individuals.Conclusion:In anti-CCP2+ at-risk individuals with MSK symptoms, anti-CCP3 antibodies improve prediction of imminent development of subclinical joint inflammation. This may represent the critical time-point for interventions to prevent the onset of joint disease. This is also a unique population for investigating the drivers of joint involvement in the development of RA.References:[1]Duquenne L, et al. The Role of Ultrasound Across the Inflammatory Arthritis Continuum: Focus on “At-Risk” Individuals. 2020.[2]D’Agostino MA, et al. Scoring ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce — Part 1: definition and development of a standardised, consensus-based scoring system. 2017.Disclosure of Interests:Andrea Di Matteo Grant/research support from: This study was conducted while Andrea Di Matteo was an ARTICULUM Fellow., Kulveer Mankia Speakers bureau: KM reports personal fees from Abbvie, UCB and Eli Lilly (all <$10.000), outside the submitted work., Grant/research support from: Research grants from BMS, Eli Lilly (all <$10.000), Laurence Duquenne: None declared, Edoardo Cipolletta: None declared, Jacqueline Nam: None declared, Leticia Garcia-Montoya: None declared, Richard Wakefield Speakers bureau: RJW has received honoraria from Abbvie, Novartis and GE for ultrasound related educational activities (all <$10.000)., Michael Mahler Employee of: MM is employee of Inova Diagnostics, commercializing CCP3, Paul Emery Speakers bureau: PE reports consultant fees from BMS, AbbVie, Gilead, Galapagos, Lilly, MSD, Pfizer, Novartis, Roche, and Samsung outside the submitted work (all <$10.000)., Grant/research support from: He also reports research grants from UCB, AbbVie, Lilly, Novartis, BMS, Pfizer, MSD and Roche, outside the submitted work. PE is National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) director and BRC funds supported this work. Leticia Garcia-Montoya and Laurence Duquenne are NIHR BRC fellows.

News (Medical) associated with INOVA Diagnostics, Inc.

13 Jan 2025

·www.prnewswire.com

Werfen Receives US FDA 510(k) Clearance for Aptiva® Antiphospholipid Syndrome Reagents

New Aptiva APS IgG and APS IgM Reagents Aid in Early Diagnosis of Antiphospholipid Syndrome in Hard-to-Diagnose Autoimmune Disease SAN DIEGO, Jan. 13, 2025 /PRNewswire/ -- Werfen today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents. Continue Reading Aptiva utilizes particle-based multi-analyte technology (PMAT) (PRNewsfoto/Werfen) The Aptiva APS IgG and APS IgM Reagents are immunoassays that utilize Aptiva's particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM in human serum. These assays aid in diagnosing both primary and secondary APS, when used in conjunction with other laboratory and clinical findings. "Antiphospholipid syndrome presents significant diagnostic challenges due to its complex symptomatology, often resembling other conditions," said Michael Mahler, PhD, Senior Vice President of Research and Development at Werfen. "The FDA clearance of the Aptiva APS IgG and APS IgM Reagents marks a crucial step forward in our mission to enhance diagnostic accuracy for autoimmune diseases. These Reagents provide comprehensive data that empower healthcare professionals to make informed decisions, ultimately improving patient outcomes and reducing the burden of misdiagnosis." The Aptiva system, a next-generation fully automated multi-analyte system, represents a significant advancement for autoimmune laboratories. By utilizing PMAT, Aptiva can deliver up to 960 results in an 8-hour shift for APS testing, allowing laboratories to handle high volumes efficiently with minimal hands-on intervention. These new APS Reagents expand Werfen's robust Aptiva portfolio, which includes the Celiac Disease and Connective Tissue Diseases (CTD) Essential Reagents. This latest clearance expands the Aptiva portfolio to 18 FDA-cleared analytes. Looking ahead, Werfen is in development to expand the Aptiva portfolio further to address additional autoimmune disease states, with over 60 analytes currently in various development stages. These efforts aim to improve the accuracy of autoimmune disease diagnoses and support more effective patient management strategies. About Werfen Werfen (werfen.com) founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's clinical areas of focus include Autoimmunity, Hemostasis, Acute Care Diagnostics, Transfusion, and Transplant. Werfen's solutions help improve the way patients with autoimmune diseases are diagnosed, monitored, and treated. The autoimmunity portfolio includes Aptiva®, BIO-FLASH®, NOVA View®, and QUANTA-Lyser® 3000 systems, and QUANTA Link® data management solution. The Werfen logo is a trademark of Werfen. Aptiva, QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite are registered trademarks of Inova Diagnostics, Inc., a Werfen company. BIO-FLASH is a registered trademark of Biokit S.A. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners. SOURCE Werfen WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyIND

19 Feb 2024

·www.prnewswire.com

Werfen Receives CE Mark for Aptiva® Antiphospholipid Syndrome Reagents

New Aptiva APS IgG and APS IgM Reagents Enable Early Diagnosis of Antiphospholipid Syndrome in Hard-to-Diagnose Autoimmune Disease SAN DIEGO, Feb. 19, 2024 /PRNewswire/ -- Werfen today announced it has received CE (Conformité Européenne) mark for its Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents under the European Union's (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR). Continue Reading Aptiva utilizes particle-based multi-analyte technology (PMAT) The Aptiva APS IgG and APS IgM reagents are immunoassays that utilize Aptiva particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. They are used as an aid in the diagnosis of primary and secondary APS, when used in conjunction with other laboratory findings. "Antiphospholipid syndrome is an autoimmune disease that manifests clinically as venous or arterial thrombosis and/or fetal loss and can be challenging to diagnose as its symptoms can mimic those of other conditions," said Michael Mahler, PhD, Vice President of Research and Development at Werfen. "Early diagnosis is crucial in preventing complications as well as unnecessary procedures and increased healthcare costs. Aptiva APS IgG and APS IgM deliver expanded information to clinicians to help with the diagnosis and management of patients with autoimmune diseases." The new Aptiva APS reagents complement Werfen's previously registered Aptiva Celiac Disease and Connective Tissue Diseases (CTD) Essential reagents and expand the number of CE Marked analytes detected by Aptiva to 19. In addition to the APS, CTD and Celiac Disease assays, Aptiva will target additional autoimmune disease states, and has over 60 analytes in various stages of advanced development. These analytes have the potential to improve the accuracy of autoimmune disease diagnosis and support better patient management. The Aptiva system is a fully automated multi-analyte system that represents the next generation of high throughput analyzers for the autoimmunity and immunology laboratory. Aptiva uses particle-based multi-analyte technology to deliver up to 120 APS results per hour. With PMAT, Aptiva enables the laboratory to complete its workload faster and with minimal hands-on time. About Werfen Werfen (werfen.com) founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Autoimmunity, Hemostasis, Acute Care Diagnostics, Transfusion, Transplant, and Original Equipment Manufacturing (OEM). Werfen's solutions help improve the way patients with autoimmune diseases are diagnosed, monitored, and treated. The autoimmunity portfolio includes Aptiva®, BIO-FLASH®, NOVA View®, and QUANTA-Lyser® 3000 systems, and QUANTA Link® data management solution. The Werfen logo is a trademark of Werfen. Aptiva, QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite are registered trademarks of Inova Diagnostics, Inc., a Werfen company, as the legal manufacturer. BIO-FLASH is a registered trademark of Biokit S.A. GEM, Premier, GEM Premier ChemSTAT, GEMweb, iQM, ChemSTAT, HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil, SynthAFax, ROTEM, Hemochron, VerifyNow and Avoximeter are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners. Photo -

Diagnostic ReagentsImmunotherapy

27 Dec 2023

·www.businesswire.com

The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition - COVID-19 Impact, Regions of Market Influence and What to Watch For Long-Term - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Worldwide Market for In Vitro Diagnostic Tests, 16th Edition" report has been added to ResearchAndMarkets.com's offering. The 16th edition of The Worldwide Market for In Vitro Diagnostic Tests is based on vendor reporting, interviews, vendor activities, and more on a global scale. This dynamic market is projected to grow over the next five years, and this resource describes all of the ways that will happen, which areas are hot and cold, and which companies stand to benefit. The 16th edition of the Worldwide Market for In Vitro Diagnostic Tests is a must have for anyone interested or involved in the IVD industry. Having a guide for the state of IVD and its future is a vital part of making well-informed decisions. The 16th edition of the Worldwide Market for In Vitro Diagnostic Tests provides readers with reliable estimates, real-world forecasts, and insights needed to understand the IVD market in its entirety. Every significant test category in IVD is given a chapter with sub-segments. It's like having ten market research reports in one. Published since 1999, this 1,500+ page report is based on vendor reporting, interviews, vendor activities, and more on a global scale. This full assessment of the IVD diagnostic market makes The Worldwide Market for In Vitro Diagnostics Tests the most trusted report by top companies in the industry. The report has complete IVD market research sections with test segment estimates and forecasts in: Clinical Chemistry, Hematology, Histology, Company Profiles and Rankings, Molecular, Immunoassay, Infectious Disease, Coagulation, Blood Bank IVD, and Point of Care. This is a very significant segment in in vitro diagnostics. The Worldwide Market for In Vitro Diagnostic Tests is the result of months of analysis and review of secondary sources by seasoned analysts, critical readings of current and historic company filings and releases, interviews with relevant experts and searching of government sources and journal literature. All test segments contain valuable information on current market size and future projection. Compound annual growth rate is provided, as well as significant IVD companies in the market and IVD manufacturer's product innovations. This detailed look at the IVD market yields unparalleled global market modeling. Why The Worldwide Market for In Vitro Diagnostic Tests? Maximum Value: One Report, All Segments, World Markets Published Since 1999, by an Expert Firm That Focuses on IVD and Related Healthcare Profiles of 300+ Companies in the Market, Detail on the Top 40 Filled with Industry-Utilized and Business Planning Numbers Learn Who is Launching Products and Investing in the IVD Industry Overall IVD Markets for Every Significant Nation, Detail for Major Markets Based on Latest Financial Reporting, Real-World Industry and Medical Practice Trends This report gives you definitive answers to important questions, including: What is the Size of IVD Market Segments? Within Those Segments, How Do They Break Down? Where Will Those Markets be In Five Years? How Has the IVD Market Changed Over Time? Who's Winning? Who's Merged? Who's Launched Game-Changing Products? What is the Competitive Landscape? Who Can I Partner With? Where are the Growth Markets I Can Enter or Buy Into? And More. The most essential report on the IVD industry, The Worldwide Market for In Vitro Diagnostic Tests, is a must-have tool for understanding the IVD market on a deeper level. Companies profiled include these, and many others: Abbott Diagnostics Accelerate Diagnostics, Inc. Altona Diagnostics Amoy Diagnostics Co. Ltd. Angle Arkray ARUP Laboratories Ascensia Diabetes Care Holdings AG Beckman Coulter Becton Dickinson (BD) BGI Genomics (formerly Beijing Genome Institute) Binding Site Group Ltd. (The) Biocartis Biocept, Inc. Biohit Biomerica Inc. bioMerieux Bio-Rad BioReference Laboratories Bio-Techne Corporation Biotheranostics Bruker CareDx, Inc. CellaVision AB Cepheid Cepheid / Danaher Cerner Corp. Copan Corgenix Medical Corporation Critical Diagnostics Curetis Cynvenio Biosystems (LungLife AI) Dako A/S Danaher Dexcom Inc. Diagnostica Stago, S.A.S. DIAGON Kft. Hungary DiaSorin Edico Genome (Illumina) Eiken Chemical Co., Ltd EKF Diagnostics Holdings Plc ELITech Group S.A.S. Epic Sciences Epigenomics AG ERBA Diagnostics, Inc. Fujirebio Fujirebio Diagnostics, Inc. Genomic Health (Exact Sciences) Greiner Bio-One International GmbH Grifols Guardant Health, Inc. Hain Lifescience GmbH Hologic Horiba Medical HTG Molecular Diagnostics Human Longevity Inc. Illumina Immucor Immunodiagnostic Systems (IDS) INOVA Diagnostics, Inc. Instrumentation Laboratory Lab Corp Leica Biosystems LifeScan Inc. Luminex Corporation Medica Corporation MedTest DX Menarini Diagnostics Meridian Bioscience, Inc. MilliporeSigma Mindray Nova Biomedical Perkin Elmer PerkinElmer, Inc. (PE) Qiagen Quest Quest Diagnostics Quidel Ortho Radiometer Randox Randox Laboratories Ltd. Rennova Health, Inc. Response Biomedical Corp. Roche Diagnostics SD Biosensor Seegene Sekisui Diagnostics LLC Shimadzu Scientific Instruments Siemens Healthineers Singulex, Inc. Snibe Co. Ltd. Sonic Healthcare Sysmex Tecan Group Thermo Fisher Scientific Tosoh Bioscience Trinity Biotech Plc Werfen For more information about this report visit https://www.researchandmarkets.com/r/p3ecam About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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