Beckman Coulter, Inc.

October 28, 2024 – BioPorto A/S (“BioPorto” or the “Company”) (CPH:BIOPOR), an in vitro diagnostics company focused on empowering the early detection of Acute Kidney Injury (AKI), today announced that it has entered into a global distribution partnership with Beckman Coulter, Inc., a global clinical diagnostics leader. Beckman Coulter will distribute BioPorto’s neutrophil gelatinase-associated lipocalin (NGAL) tests for use on Beckman Coulter family of DxC and AU clinical chemistry analyzers. Per the agreement, Beckman Coulter will initially distribute BioPorto’s NGAL test in Europe followed by distribution in the United States pending US Food and Drug Administration (FDA) marketing clearance for ProNephro AKI (NGAL) for use on the Beckman Coulter’s analyzers. The agreement allows for expansion into other geographic areas. Kathleen Orland, Senior Vice President and General Manager, Clinical Chemistry and Immunoassay, of Beckman Coulter, commented: “We are excited by this new partnership with BioPorto on AKI assays underscoring the clinical importance and demand of NGAL as a biomarker. We look forward to now being able to offer BioPorto’s NGAL assay on our global installed base to improve kidney health management worldwide.” The agreement with Beckman Coulter is a significant milestone in the execution of BioPorto’s strategy implemented earlier in 2024 and the Company’s goal to expand its global distribution network for ProNephro AKI (NGAL) and the NGAL Test™ by partnering with leading clinical chemistry instrument manufacturers. Ultimately, this joint commitment will enable more laboratories to rapidly implement the test and increase the serviceable market. Peter Mørch Eriksen, Group CEO of BioPorto, commented: "Entering into this agreement with Beckman Coulter represents a significant milestone in our partnership portfolio. Beckman Coulter is renowned for its innovative instruments and its ability to seamlessly integrate partner assays and technologies into its analyzer family. At BioPorto, our mission is to empower healthcare professionals to address the substantial unmet medical needs of patients at risk of AKI. By expanding our distribution network, enhancing the portfolio of instruments capable of running our tests and securing collaborations with leading global manufacturers, we are well-positioned to accelerate the adoption of our AKI assessment tests. This partnership with Beckman Coulter underscores the compelling value of our technology and our commitment to improving patient outcomes.” The content of this announcement does not affect BioPorto’s latest financial guidance for 2024 as most recently described in its Interim Report for second quarter 2024. This announcement has been prepared in English and Danish. In case of discrepancy, the English version shall prevail. To receive BioPorto’s Company Announcements, Press Releases, Newsletters and other business relevant information, please sign up on https://bioporto.com/investor-contact/. For inquiries, please contact Tim Eriksen, Zenith Advisory, +45 4529 0000, investor@bioporto.com Ashley R. Robinson, LifeSci Advisors, +1 617 430 7577, arr@lifesciadvisors.com Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs and is common in patients who are in hospital intensive care units. For more information about AKI please visit: https://bioporto.com/aki/. BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem. The Company’s flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide. BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com. Beckman Coulter, Inc., is a global clinical diagnostics leader. To learn more about Beckman Coulter, Inc., please visit: https://www.beckmancoulter.com/. 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DUBLIN--( BUSINESS WIRE )--The "Monkeypox (MPOX) Diagnostics Global Markets 2024-2028, by Assay, by Country, by Product and by Place: Executive and Consultant Guides, Market Analysis and Forecasts" report has been added to ResearchAndMarkets.com's offering. Monkeypox is being declared a health emergency. Governments around the world are preparing to use widespread testing to get in front of this threat from the beginning. Opportunities abound for the In Vitro Diagnostic Industry. The report forecasts the market size out to 2028. Learn about this market including the issues and outlooks. The two key trends of Rapid Diagnostics and the Genomics Revolution are merging to create new diagnostic opportunities. Growth is coming from the basic factors but the COVID Pandemic has changed to market landscape now and for the foreseeable future. Some players have already made their mark but disruptive diagnostic technology could change the playing field. This research makes you the expert in your organization. Make investment decisions and valuations with confidence using the latest data. All report data is available in Excel format on request. Key Topics Covered: 1 Market Guides 1.1 Situation Analysis 1.2 Guide for Executives and Marketing Staff 1.3 Guide for Investment Analysts and Management Consultants 2 Introduction and Market Definition 2.1 An Overview of Monkeypox Diagnostics 2.1.1 The 2022 Outbreak 2.2 Market Definition 2.2.1 Market Size 2.2.2 Currency 2.2.3 Years 2.2.4 PCR 2.2.5 NGS 2.2.6 Immunoassay 2.2.7 Rapid Diagnostics 2.2.8 Limitations 2.3 Methodology 2.3.1 Methodology 2.3.2 Sources 2.3.3 Authors 2.4 Perspective: Healthcare and the IVD Industry 2.4.1 Global Healthcare Spending 2.4.2 Spending on Diagnostics 2.4.3 Important Role of Insurance for Diagnostics 3 Monkeypox - Current Science 3.1 What is Monkeypox? 3.2 Outbreaks 3.3 Transmission 3.4 Signs and symptoms 3.5 Diagnosis 3.6 Therapeutics 3.6.1 Vaccination 3.6.2 Prevention 3.6.2.1 Reducing the risk of human-to-human transmission 3.6.2.2 Reducing the risk of zoonotic transmission 3.7 How monkeypox relates to smallpox 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 Pharmaceutical/Reagent Supplier 4.1.4 Independent Testing Lab 4.1.5 Public National/regional lab 4.1.6 Hospital lab 4.1.7 Physician Lab 4.1.8 Audit Body 4.1.9 Certification Body 5 Market Trends 5.1 Factors Driving Growth 5.1.1 Prevalence 5.1.2 Surveillance 5.1.3 Pandemic Wind Down 5.1.4 Viral Zeitqeist 5.1.5 Healthcare Spend 5.2 Factors Limiting Growth 5.2.1 The Cost Curve Shrinks the Market 5.2.2 Transmission Outlook 5.2.3 Adoption Lag and Cost Control 5.3 Diagnostic Technology Development 5.3.1 The Multiplex Opportunity 5.3.2 Shifting Role of Physicians in Diagnosis 5.3.3 Diagnostics Moves Out of the Lab 5.3.4 Biomarkers and Algorithms 5.3.5 Rapid Testing Changing Medical Practice 5.3.6 Genome Role and Big Data 6 Mpox Diagnostics - 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 WHO Declares MPOX a Health Emergency 6.3 Human monkeypox disease prediction 6.4 Most Dangerous Monkeypox Virus Yet 6.5 South Africa reports second mpox death 6.6 New Strain of MPOX Raising Alarm 6.7 Labcorp Receives EUA for Home Mpox Test 6.8 Ultrasensitive single-step CRISPR detection of MPOX virus 6.9 Many new mpox cases are in China 6.10 U.S. to declare monkeypox a public health emergency 6.11 BioGX Gets CE-IVD Mark for Multigene POC Test 6.12 World Health Organization declares monkeypox a global emergency 6.13 Quest Begins Offering Internally Developed Monkeypox Test 6.14 CDC, Abbott, Roche, BioMerieux Get FDA 510(k) Clearances 6.15 Commercial, Academic Labs Ramp Up Monkeypox Testing 6.16 Becton Dickinson, CerTest Biotec Collaborate on Monkeypox MDx 6.17 Monkeypox Virus Sequenced 7 Profiles of Key Companies 7.1 Abbott Laboratories 7.2 Aegis Science Corporation 7.3 Applied DNA Sciences 7.4 Beckman Coulter Diagnostics (Danaher) 7.5 Becton, Dickinson and Company 7.6 BGI Genomics Co. Ltd 7.7 BioFire Diagnostics (bioMerieux) 7.8 BioGX 7.9 bioMerieux Diagnostics 7.10 Bio-Rad Laboratories, Inc. 7.11 Cepheid (Danaher) 7.12 Cerstest Biotec 7.13 Flow Health 7.14 Laboratory Corporation of America 7.15 Mayo Clinic Laboratories 7.16 Novacyt 7.17 Proof Diagnostics 7.18 Qiagen 7.19 Quest Diagnostics 7.20 Roche Diagnostics 7.21 Siemens Healthineers 7.22 Sonic Healthcare 7.23 Sysmex 7.24 Thermo Fisher Scientific 7.25 Vela Diagnostics 8 Monkeypox Global Diagnostic Markets Overview 8.1 Monkeypox Diagnostics - Global Market Overview by Country 8.2 Global Monkeypox Diagnostics Markets Overview by Assay 8.3 Global Monkeypox Diagnostics Markets Overview by Product 8.4 Global Monkeypox Diagnostics Markets Overview by Place 9 Monkeypox Diagnostic Market - by Assay 9.1 Monkeypox Diagnostic - PCR 9.2 Monkeypox Diagnostic - NGS 9.3 Monkeypox Diagnostic - Immunoassay 9.4 Monkeypox Diagnostic - Other Assay 10 Global Monkeypox Diagnostics Markets - By Product 10.1 Monkeypox Diagnostic - Instrumentation 10.2 Monkeypox Diagnostic - Consumables 10.3 Monkeypox Diagnostic - Software & Service 11 Global Monkeypox Diagnostics Markets - By Place 11.1 Monkeypox Diagnostic - Hospital 11.2 Monkeypox Diagnostic - Clinic/POL 11.3 Monkeypox Diagnostic - Other Place 12 Appendices 12.1 Commercially Available Monkeypox Tests 12.2 United States Medicare System: Clinical Laboratory Fees Schedule For more information about this report visit https://www.researchandmarkets.com/r/5a91a3 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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The collaboration between ALZpath and Beckman Coulter marks a significant step toward making early detection more accessible and less invasive. The introduction of a blood-based diagnostic test, featuring ALZpath’s novel pTau217 antibody, could transform how Alzheimer’s is diagnosed and treated worldwide. In this Q&A, Chad Holland, president and CEO at ALZpath, and Frederic Jean, vice president strategy and business development at Beckman Coulter, share insights into this groundbreaking partnership and its potential impact. How do you foresee the landscape of early Alzheimer’s diagnosis changing globally with the integration of ALZpath’s pTau217 antibody into Beckman Coulter’s DxI 9000 Immunoassay Analyzer? ​ Chad Holland (CH): ​Alzheimer’s and related dementias are expected to impact nearly 139 million people globally by 2050. Current diagnostics like PET imaging and spinal taps, though effective, are invasive, costly, and inaccessible to many. Blood-based biomarkers, like our pTau217 antibody, offer a scalable and less invasive alternative. This antibody is integral to advanced blood-based tests that are transforming Alzheimer’s diagnosis, treatment, and real-time disease monitoring. Our collaboration with Beckman Coulter aims to democratize access to the pTau217 antibody, developing it into a highly accurate blood-based test on the DxI 9000 analyzer. This will expand global access to precision diagnostics, significantly enhancing early diagnosis and treatment initiation as new therapies emerge. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Frederic Jean (FJ): ​One major challenge for the widespread adoption of a new Alzheimer’s blood test will be clinician education. While media interest will likely be high, clinicians need detailed information on the assay’s clinical utility. We’re establishing partnerships with Alzheimer’s research centers, pharmaceutical companies, and patient advocacy groups to generate and share clinical evidence. This will help drive the creation of new guidelines and encourage adoption. What makes the pTau217 antibody stand out in terms of diagnostic accuracy and sensitivity compared to other biomarkers? ​ CH: ​Despite Alzheimer’s prevalence, with 55 million affected globally, nearly 75% of patients remain undiagnosed. Traditional diagnostics are invasive, expensive, and often lead to long wait times. Blood-based tests offer a less invasive and more accessible alternative, but detecting Alzheimer’s biomarkers in the bloodstream requires high precision. The pTau217 antibody stands out for its diagnostic accuracy and sensitivity, comparable to PET imaging and CSF analysis. By integrating it into widely available testing platforms, we can provide affordable and convenient blood tests for patients worldwide, revolutionizing Alzheimer’s research and patient care. FJ: ​The challenge in neurodegenerative diseases lies in identifying clinically relevant biomarkers circulating at very low concentrations in blood. The synergy between ALZpath’s expertise and our high-sensitivity immunoassay technology offers a unique opportunity to accelerate the identification and development of new biomarkers, potentially beyond Alzheimer’s. Why did ALZpath choose to partner with Beckman Coulter for this licensing agreement? ​ CH: ​ALZpath aims to democratize access to our robust pTau217 antibody, enabling its use by researchers, clinicians, and industry partners globally. Incorporating it into highly sensitive assays run on Beckman Coulter’s DxI 9000 analyzers aligns perfectly with our goal of advancing patient care outcomes on a global scale. What strategies are in place to ensure this diagnostic tool reaches underserved and rural populations globally? ​ FJ: ​We are developing a simple, easy-to-use blood test that will be available on Beckman Coulter’s fully automated immunoassay platform, used in hospitals and laboratories across more than 110 countries. Our range of analyzers meets the needs of various laboratory sizes, from small rural hospitals to large central labs, ensuring consistent quality of results worldwide. Can you share a specific example where this new blood-based test could significantly alter a patient’s diagnostic journey or treatment plan? ​ CH: ​The pTau217 antibody enters the market at a critical time for early Alzheimer’s detection, allowing patients to benefit from advanced therapies, specialized care, and early interventions. Traditional diagnostics can take up to nine months, during which patients may experience cognitive decline. Our antibody, once commercialized, will enable rapid, convenient, and affordable blood testing, significantly improving diagnosis and treatment timelines. The partnership between ALZpath and Beckman Coulter holds the promise of transforming Alzheimer’s diagnosis and care, bringing cutting-edge, accessible diagnostic tools to the global stage. As these innovations reach more patients, the landscape of Alzheimer’s treatment could be fundamentally altered, offering hope for millions affected by the disease.