bioMérieux SA

MARCY L'ÉTOILE, France, March 18, 2025 /PRNewswire/ -- bioMérieux, a world leader in the field of in vitro diagnostics, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance for VITEK® COMPACT PRO. This innovative system for microorganism identification (ID) and antibiotic susceptibility testing (AST) will benefit clinical laboratories to help diagnose infectious diseases and combat antimicrobial resistance, and industrial laboratories to identify contaminants for ensuring consumer safety. Every year 11 million people worldwide die of sepsis1 and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria2. Antimicrobial resistance (AMR) continues unabated making detection of resistant pathogens more complex. Clinicians need to receive accurate identification and faster antibiotic susceptibility test (AST) results, to enable timely and optimized patient intervention. For over 30 years as a global leader in automated ID/AST systems, bioMérieux continues to collaborate with laboratory professionals and clinicians to innovate microbiology solutions for improved patient health management, operating cost efficiencies, and effective antimicrobial stewardship (AMS). VITEK® COMPACT PRO combines the latest diagnostic technology with the globally acknowledged advantages of its predecessor: VITEK® 2 COMPACT. With an ergonomically advanced design and a simplified workflow, it further enhances the user experience and improves overall efficiency as the laboratory technician has to spend less time for sample loading and processing3. It offers one of the most efficient workflows, fastest routine ID/AST results and microbiology expertise for accurate and confident diagnostics insights4. Ideally suited for small and medium-sized laboratories, VITEK® COMPACT PRO will also enable laboratories transitioning from manual workflows to benefit from automation efficiencies. "For decades, bioMérieux has been an industry leader in microbiology innovation. With the introduction of VITEK® COMPACT PRO, we are continuing this journey and delivering on the specialized needs of our customers – supporting laboratories with simplified, efficient workflows and the latest technology to optimize their experience. Through ongoing expansion of our VITEK® solutions portfolio, bioMérieux continues to strengthen our comprehensive AMR/AMS offer and reinforce our commitment to provide next-generation ID/AST systems to healthcare and laboratory professionals around the world," commented Jennifer Zinn, Executive Vice President, Clinical Operations. "As a leader in the fight against AMR, bioMérieux continuously innovates by developing and renewing its key diagnostic solutions. VITEK® COMPACT PRO delivers fast, accurate and reproducible results comparable to VITEK® 2 and VITEK® 2 COMPACT systems. The ergonomic features, a new intuitive user interface, and an updated software with one of the most comprehensive knowledge database makes VITEK® COMPACT PRO highly appealing to both clinical and industrial laboratories." added Céline Roger-Dalbert, Executive Vice President, Research and Development. For industrial applications, VITEK® COMPACT PRO will be used for routine identification of pathogens to ensure the quality and safety of food, pharmaceutical, and cosmetic products. The commercial launch of VITEK® COMPACT PRO is initially planned in select countries, followed by global launch starting in the second quarter of 2025. 1 Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet (London, England). 2020;395(10219):200-11. 2 Murray CJ. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:(21)02724-0. 3 bioMérieux proprietary data on file: VITEK® COMPACT PRO vs. VITEK® 2 COMPACT 4 Decarli A et al. JMM. 2022; 71:001543; bioMérieux proprietary data on file; Rommler W et al. ASM 2006; Poster C-123; Heller-Ono A Seln. of Publications VITEK® 2: bioMérieux White Paper 2008; Lombardi Vincent J, Seln. of Publications VITEK® 2: bioMerieux White Paper 2011; Hooper M et al. ECCMID 2013; Poster P-1536; Carvalhaes CG et al. ECCMID 2023 Poster # P0384. ABOUT BIOMÉRIEUX'S COMPLETE ANTIMICROBIAL STEWARDSHIP (AMS) SOLUTION bioMérieux's healthcare mission is to help sustain the use of antibiotic efficacy for generations to come. To support hospitals, institutions, and laboratories with their AMS programs, bioMérieux has a complete solution covering antibiotic therapy initiation, optimization, and discontinuation. This constantly evolving offer provides timely, accurate results to adjust therapy, transforms data into actionable insights, and integrates smoothly into any hospital with its flexible partnership approach. bioMérieux has more than 60 years of microbiology expertise with 75% of its R&D directed to research on antimicrobial resistance to ensure the current offer evolves to meet customers' AMS needs. ABOUT BIOMÉRIEUX Pioneering Diagnostics A world leader in the field of in vitro diagnostics since 1963, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors. In 2024, revenues reached €4 billion, with over 93% of sales outside of France. bioMérieux provides diagnostic solutions (systems, reagents, software, and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in food, pharmaceutical and cosmetic products. . bioMérieux is listed on the Euronext Paris stock market. Symbol: BIM – ISIN Code: FR0013280286 Reuters: BIOX.PA/Bloomberg: BIM.FP CONTACTS SOURCE bioMérieux WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Oslo, Norway, 13 January 2025 — SpinChip Diagnostics ASA (“SpinChip”), an innovative diagnostics company developing next-generation Point of Care platforms for in vitro diagnostics, announces its agreement to be acquired by bioMérieux, a global leader in in vitro diagnostics. Under the agreement, bioMérieux will acquire 100% ownership of SpinChip for a Total Enterprise Value of NOK 1,624 million. Morten Jurs, Chief Executive Officer of SpinChip, stated: “The dedication of the SpinChip team over the past decade has been exceptional. Their relentless efforts have led to the development of a groundbreaking diagnostics platform that has the potential to significantly improve healthcare outcomes for patients. Our recent collaboration with bioMérieux has been highly productive and has brought us closer to the commercialisation of the platform. I am confident that bioMérieux’s leadership will effectively utilise the platform’s potential to provide efficient and improved diagnostic solutions for patients and healthcare workers worldwide.” Pierre Boulud, Chief Executive Officer of bioMérieux, commented: “The acquisition of SpinChip is very promising for bioMérieux and fully consistent with our GO•28 strategic plan agenda. We already serve the point-of-care market with BIOFIRE® SPOTFIRE®, a best-in-class molecular biology system. SpinChip’s groundbreaking technology complements our offering and strengthens our presence in the Point of Care segment. This acquisition will also allow us to leverage bioMérieux’s unique R&D and manufacturing capabilities in the field of immunoassays that we have built with VIDAS®. SpinChip will pave the way for bioMérieux’s growth beyond 2028, sustaining our mission to enhance patient outcomes worldwide.” Since its founding in 2012, SpinChip has developed a revolutionary in vitro diagnostics platform capable of rapidly conducting a wide range of tests across therapeutic areas such as cardiovascular, inflammatory/sepsis, infectious and endocrine diseases. With this, SpinChip’s technology aims to enhance diagnostic efficiency for patients and physicians while reducing healthcare costs. The SpinChip platform currently delivers highly accurate diagnostic results for detecting Myocardial Infarction (MI), a leading cause of global morbidity and mortality. Capable of producing results comparable to state-of-the-art laboratory diagnostic machines within minutes and near the patient, the platform is particularly suited for Emergency Departments and Urgent Care Units. SpinChip’s high-sensitive troponin MI assay has already demonstrated strong results in a retrospective clinical study (“Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay”). The assay is now undergoing additional national and international trials, including a large multicenter European clinical study. SpinChip plans to launch the MI assay during H1 2026. Under bioMérieux’s ownership, the platform and additional immunoassays in the area of acute care, focusing on sepsis and other cardiovascular biomarkers, will be developed. Stig Morten Borch, Founder of SpinChip, added: “Our vision has always been to improve diagnostic speed and accuracy, offering performance on par with central laboratory assays. With bioMérieux’s expertise, we are now on the cusp of commercializing our first test. I am immensely grateful to Sintef’s initial support and everyone who has supported our journey. I am also confident in bioMérieux’s ability to bring our innovation to market.” Åse Aulie Michelet, Chair of SpinChip, remarked: “This transaction reflects the cutting-edge advancements made by SpinChip. Throughout our journey, Investinor, as our anchor investor since 2016, has been an important contributor to the company’s success. As a global leader in in vitro diagnostics, bioMérieux is the perfect partner to drive SpinChip’s platform to commercialization and beyond. Carnegie Investment Bank and ABG Sundal Collier acted as financial advisors and Wiersholm as legal advisor to SpinChip and its owners in connection with the transaction. Contact information: Morten Jurs, Chief Executive Officer SpinChip Diagnostics ASA E-mail: mj@spinchip.no Phone: +47 991 67 922 About SpinChip Diagnostics ASA Representing the future of point-of-care testing, SpinChip was founded in Norway in 2012. SpinChip’s proprietary platform is focused on in-vitro diagnostics (IVD) to develop diagnostic tests for acute and chronic cardiac indications where test results are rapidly needed to provide patients with life-saving treatments. The platform is based on a unique microfluidic technology in combination with nanotechnology-based cartridge assays, which together can relay test results as accurately as a high-sensitive laboratory diagnostic machine within minutes, based on a fraction of a droplet of blood.

DUBLIN--( BUSINESS WIRE )--The "Clinical Laboratory Molecular Diagnostics for Infectious Disease Market: Forecasts by Application by Place and by Country, with Market Analysis & Executive Guides" report has been added to ResearchAndMarkets.com's offering. The report has hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help sharpen your pricing along with the most frequently used and billed tests. Again, assistance in using the information is normally provided without additional charges. The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report. The Molecular Diagnostics - Infectious Disease sector of the clinical diagnostics industry is poised for further growth. A market that just keeps on growing but is becoming more complex and segmented. Find out what's happening in this informative report. Find out about the impact of multiplex assays which threaten to change diagnosis and treatment forever. Exciting technical developments especially in the seesaw between nucleic acid testing and immunoassay, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication. This research makes you the expert in your organization. The report includes five year market forecasts. The section on the Clinical Laboratory Market Segments and Industry Structure provides an analysis of the laboratory market, detailing traditional segmentation and focusing on specific areas like syndromic testing. It explores how different types of labs, including hospital labs, central labs, and physician office labs (POLs), segment their services based on testing needs. The industry structure section discusses the distribution of testing among hospitals, the economies of scale achieved by larger lab networks, and the competition between hospital-based labs and centralized laboratories. It also highlights the role of physician offices and the growing relevance of Point-of-Care Testing (POCT), reflecting the shifting dynamics in where and how diagnostic testing is conducted. This summary encapsulates the key market dynamics and structural elements of the clinical laboratory industry. Infectious disease testing directly benefits from the explosion in biotechnology, especially genomics. Learn all about it in this new report. A range of dynamic trends are pushing market growth and company valuations. Trends like Multiplex testing Pathogen evolution and pandemics Biotechnology advances in genetics Climate change Globalization The rise of rapid testing Key Topics Covered: 1 Market Guides 1.1 Situation Analysis 2 Introduction and Market Definition 2.1 Market Definition 2.2 Methodology 2.3 Perspective: Healthcare and the IVD Industry 2.3.1 Global Healthcare Spending 2.3.2 Spending on Diagnostics 2.3.3 Important Role of Insurance for Diagnostics 2.4 The Nature of the IVD Product 2.4.1 Features Overview 2.4.2 The Misunderstood Feature 2.4.3 Regulation 2.4.4 The Newest Feature 2.4.5 The Oldest Feature 2.4.6 All About Scope 2.4.7 Why Turnaround is Becoming More Important 2.4.8 The Role of Trust 2.5 The IVD Product of the Future 3 Infectious Diseases - Guide to the Pathogens 3.1 Infectious Disease Pathogens - The Big Picture 3.1.1 Viruses 3.1.2 Bacteria 3.1.3 Fungi 3.1.4 Parasites 3.1.5 Prions 3.1.6 Virulence 3.1.7 Transmission 3.2 The Coronavirus 3.2.1 Severe acute respiratory syndrome (SARS) 3.2.2 Middle East respiratory syndrome (MERS) 3.2.3 COVID-19. The SARS CoV 2 Virus. 4 Industry Overview 4.1 Players in a Dynamic Market 4.1.1 Academic Research Lab 4.1.2 Diagnostic Test Developer 4.1.3 Instrumentation Supplier 4.1.4 Chemical/Reagent Supplier 4.1.5 Pathology Supplier 4.1.6 Independent Clinical Laboratory 4.1.7 Public National/regional Laboratory 4.1.8 Hospital Laboratory 4.1.9 Physicians Office Lab (POLS) 4.1.10 Audit Body 4.1.11 Certification Body 4.2 The Clinical Laboratory Market Segments 4.2.1 Traditional Market Segmentation 4.2.2 Laboratory Focus and Segmentation 4.2.3 Segmenting the Syndromic Testing Market 4.3 Industry Structure 4.3.1 Hospital Testing Share 4.3.2 Economies of Scale 4.3.3 Hospital vs. Central Lab 4.3.4 Physician Office Labs 4.3.5 Physicians and POCT 5 Market Trends 5.1 Factors Driving Growth 5.1.1 The Nucleic Acid Impact 5.1.2 Population Dynamics 5.1.3 The Developing World 5.1.4 Decentralization 5.1.5 Self Testing 5.1.6 The Need for Speed 5.2 Factors Limiting Growth 5.2.1 Costs and Experience Curve Effects 5.2.2 The Role of ID Prevalence 5.2.3 Wellness 5.2.4 The Impact of Living Standards 5.3 Instrumentation, Automation and Diagnostic Trends 5.3.1 Traditional Automation and Centralization 5.3.2 The New Automation, Decentralization and Point Of Care 5.3.3 Instruments Key to Market Share 5.3.4 Bioinformatics Plays a Role 5.3.5 PCR Takes Command 5.3.6 Next Generation Sequencing Fuels a Revolution 5.3.7 NGS Impact on Pricing 5.3.8 Whole Genome Sequencing, A Brave New World 5.3.9 Companion Diagnostics Blurs Diagnosis and Treatment 6 Clinical Laboratory MDx Infectious Disease Recent Developments 6.1 Recent Developments - Importance and How to Use This Section 6.1.1 Importance of These Developments 6.1.2 How to Use This Section 6.2 Roche Respiratory Panel Receives FDA EUA 6.3 Genetic Signatures Gets Approval for GI Parasite Panel 6.4 Diasorin Expands Respiratory Panel 6.5 BioMerieux Outlines MDx-Driven Growth 6.6 T2 Biosystems Gets Extended T2Bacteria Panel 6.7 Diasorin Aims to Deliver Updated Instruments, New Assays 6.8 Oxford Nanopore Nabs Investment From BioMerieux 6.9 Day Zero Diagnostics Closes Financing Round 6.10 Spindiag Seeks Investors for Rapid PCR System 6.11 Sorrento Therapeutics Nabs Contract for Dx Platform 6.12 Kephera Planning Menu of Infectious Disease Tests 6.13 Oxford Nanopore and BioMerieux to Develop IDDx 6.14 SD Biosensor Eyes Global Expansion 6.15 Selux Dx Next Gen Phenotyping Gets FDA Clearance 6.16 Takara Developing High-Throughput Multiplex Panels 6.17 BioGX Debuts New Point-of-Care Molecular Testing System 6.18 Nanopath MDx Platform Providing 15-Minute Results 6.19 ProtonDx Commercializing Rapid MDx Instrument 6.20 Siemens Healthineers to Develop Next-Gen, High-Throughput MDx Platform 6.21 Hologic Obtains CE Mark for MDx Epstein-Barr, BK Virus Assays 6.22 Pathogenomix Infectious Disease Platform Uses Cloud-Based Analytics, NGS 6.23 Accelerate Diagnostics Anticipates Growth 6.24 Growth of Decentralized Testing Expected to Continue 6.25 Lumos Diagnostics Expanding Test Portfolio 6.26 Study Validates Karius Cell-Free DNA to Detect Hundreds of Pathogens 6.27 CareDx, IDbyDNA Develop Infectious Disease Dx for Transplant Patients 7 Key Companies 7.1 Abbott Laboratories 7.2 Agilent 7.3 Altona Diagnostics 7.4 Anitoa 7.5 Autonomous Medical Devices 7.6 Beckman Coulter Diagnostics (Danaher) 7.7 Becton, Dickinson and Company 7.8 BioGX 7.9 Biomatik 7.10 bioMerieux Diagnostics 7.11 Bio-Rad Laboratories, Inc 7.12 Cepheid (Danaher) 7.13 Diasorin S.p.A. 7.14 DNAe 7.15 Flow Health 7.16 Global Access Diagnostics 7.17 Great Basin Scientific, Inc 7.18 Hologic 7.19 Novacyt 7.20 Novus Diagnostics 7.21 Oncimmune 7.22 One Codex 7.23 OraSure Technologies 7.24 Proof Diagnostics 7.25 Qiagen 7.26 QuidelOrtho 7.27 R-Biopharm AG 7.28 Response Biomedical 7.29 Revvity 7.30 Roche Diagnostics 7.31 Siemens Healthineers 7.32 Thermo Fisher Scientific 7.33 Vela Diagnostics 7.34 Veredus Laboratories 7.35 YD Diagnostics 7.36 Zhejiang Orient Gene Biotech 8 The Global Market for Clinical Laboratory MDx Infectious Disease 8.1 Global Market Overview by Country 8.2 Global Market by Application - Overview 8.3 Global Market by Place - Overview 9 Global Clinical Laboratory MDx Infectious Disease Markets - By Application 9.1 Respiratory 9.2 Blood Borne Virus 9.3 Transplant 9.4 Hospital Acquired Infections 9.5 Reproductive Health 9.6 C19 Singleplex 9.7 Meningitis 9.8 Gastrointestinal 9.9 Tropical 10 Global Clinical Laboratory MDx Infectious Disease Markets - By Place 10.1 Hospital Lab 10.2 Outpatient Lab 10.3 Point of Care 10.4 Other Place 11 Appendices 11.1 Growth of Approved IVD Test Menu 11.2 Growth of Approved Average IVD Test Fee 11.3 The Most Used IVD Assays 11.4 The Highest Grossing Assays 11.5 Laboratory Fees Schedule For more information about this report visit https://www.researchandmarkets.com/r/fte25m About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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