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Business Wire
17 hours ago
- Business
- Business Wire
QIAGEN and Incyte Announce Precision Medicine Collaboration to Develop Companion Diagnostics for Patients With Mutant CALR-expressing Myeloproliferative Neoplasms (MPNs)
VENLO, Netherlands & WILMINGTON, Del.--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Incyte (Nasdaq: INCY) today announced a new global collaboration to develop a novel diagnostic panel to support Incyte's extensive portfolio of investigational therapies for patients with myeloproliferative neoplasms (MPNs), a group of rare blood cancers, including Incyte's monoclonal antibody INCA033989, targeting mutant calreticulin (mutCALR), which is being developed in myelofibrosis (MF) and essential thrombocythemia (ET). Under the terms of the Master Collaboration Agreement with Incyte, QIAGEN will develop a multimodal panel using next-generation sequencing (NGS) technology for detecting clinically relevant gene alterations in hematological malignancies. The panel will be validated using the next-generation sequencing (NGS) technology and the Illumina NextSeq 550Dx platform as part of QIAGEN's partnership with Illumina (NASDAQ: ILMN) to leverage its NGS diagnostic platforms for patient testing by laboratories worldwide. QIAGEN will support regulatory submission processes and market access activities across the United States, European Union and Asia-Pacific regions. Myeloproliferative neoplasms are a group of diseases representing about 40% of hematological malignancies, characterized by chronic accumulation of different mature blood cell types in blood. Identifying genomic aberrations in clinically relevant biomarkers like CALR are shown to be key, especially in MPNs. Incyte is at the forefront of developing novel therapies, including INCA033989 for patients with mutCALR ET or MF, that target only malignant cells, sparing normal cells. The use of companion diagnostics helps guide clinicians in making treatment decisions that can lead to better patient outcomes. 'Following our presentation of positive, late-breaking data from our first-in-class mutCALR-targeted antibody at EHA, we are excited to announce this partnership with QIAGEN, which will facilitate CALR testing for patients with MPNs on a global basis. The development of companion diagnostics for mutCALR, coupled with the potential for new medicines to selectively target disease-initiating cells, is a critical step toward changing the course of disease in patients with ET and MF,' said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. 'As a partner, QIAGEN has the proven expertise in companion diagnostics development and approvals needed to support our ongoing work and commitment to transforming the treatment of patients with CALR-mutant MPNs.' 'Together with Incyte we are building a multimodal companion diagnostic using a powerful technology like next-generation sequencing to facilitate highly accurate testing for several blood cancer genes at once,' said Jonathan Arnold, Vice President and Head of Partnering for Precision Diagnostics at QIAGEN. 'This new partnership strengthens our role in offering companion diagnostics for the growing number of biomarkers being discovered in onco-hematology and maximizing the clinical utility of the diagnostic for payor and patient benefit, thus supporting the work of innovative, science-driven companies like Incyte to improve patient outcomes.' About Mutations in Calreticulin (mutCALR) Calreticulin (CALR) is a protein involved in the regulation of cellular calcium levels and normal protein production. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (MPNs), i a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells. ii,iii Among the two types of MPNs, essential thrombocythemia (ET) and myelofibrosis (MF), mutCALR drives 25-35% of all cases. i,ii About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of March 31, 2025, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. For more information, visit QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics, having more than 30 master collaboration agreements with global pharmaceutical and biotechnology companies to develop and commercialize diagnostic tests. QIAGEN's offering to these companies encompasses technologies ranging from polymerase chain reaction (PCR), near-patient testing and digital PCR (dPCR) to next-generation sequencing (NGS), and sample types from liquid biopsy to tissue. It also spans disease areas from cancer to non-oncology diseases such as neurodegenerative, inflammatory, and metabolic diseases – including 16 FDA-approved PCR-based companion diagnostics. For more information about QIAGEN's efforts in precision medicine please visit About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. QIAGEN Forward-Looking Statement Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from restructuring programs and acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the 'Risk Factors' contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential for Incyte's mut-CALR targeted antibody (INCA033989) to provide a potential treatment option for patients with ET or MF, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements. Source: QIAGEN N.V. Category: Precision Medicine
Yahoo
15-04-2025
- Business
- Yahoo
QIAGEN Advancing Plans to Launch Three New Sample Preparation Instruments by 2026 to Improve Lab Automation
Three new innovative instrument launches expand reach into further lab segments and sample preparation customers as QIAGEN strengthens market-leading position QIAsymphony Connect set to start phased launch in 2025, first customer sessions being held to highlight enhanced capabilities for oncology and genomics workflows QIAsprint and QIAmini on track for 2026 launches, expanding options for high- and low-throughput lab demands VENLO, Netherlands, April 15, 2025--(BUSINESS WIRE)--QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that plans are advancing to launch three new sample preparation instruments during 2025 and 2026 to expand and strengthen its portfolio for automated sample preparation. These systems are designed to deliver new levels of efficiency and sustainability for laboratories worldwide and address different customer segments: QIAsymphony Connect, which marks the next generation of the flagship QIAsymphony with over 3,300 cumulative placements, is progressing well toward a phased launch to selected customers starting in customer sessions are being held at industry events during 2025 – including at the ESCMID (European Society of Clinical Microbiology and Infectious Diseases) conference in April 2025 in Vienna – to showcase the system's enhanced capabilities in select settings upon request. The QIAsymphony Connect addresses pathogen nucleic acid extraction and various other applications including liquid biopsy, a non-invasive method for detecting cancer and other diseases through blood samples, as well as oncology, genomics, and clinical research system can process up to 96 samples at a time and features improved automation capabilities for sample tracking and new applications, higher yield for increase in assay sensitivity and digital connectivity. It is compatible with QIAsphere, QIAGEN's cloud-based platform for remote monitoring, software updates and instrument status. It is being designed for in vitro diagnostic (IVD) use globally, enabling compliant workflows in most countries and including the U.S. and Europe. QIAsprint Connect, on track for launch in 2026, marks the entry of QIAGEN into automated high-throughput sample first demonstrations of QIAsprint Connect have showcased the system's potential to process up to 192 samples per run with less than 30 minutes of hands-on time, enabling labs to scale up to 600 samples per day. The system supports both pre-programmed and customizable protocols, and its consumables are designed with sustainability in mind, reducing plastic waste by up to 50%."We were excited to test the QIAsprint. Its user-friendly design and ability to process large sample numbers efficiently is an ideal solution for laboratories like ours," said Kerstin Luxa of the Max Planck Institute for Plant Breeding Research in Cologne, system supports a wide range of sample types, such as plant, microbial, soil, stool and human tissues, and is already being used to develop nine different applications. Its flexibility makes it ideal for labs working across various areas. QIAmini, also on track for launch in 2026, expands QIAGEN's automation portfolio into the low-throughput cost-effective and low-complexity entry into automation brings the reliability of QIAGEN trusted kits to smaller labs and batch sizes. Ideal for replacing tedious pipetting, it delivers the reproducibility of automation with the flexibility to scale as complements QIAGEN's portfolio alongside the updated QIAcube Connect and EZ2 Connect systems, offering automation options for even smaller-scale workflows. "These new sample preparation systems underscore our commitment to helping labs operate more efficiently, sustainably and flexibly," said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN. "With QIAmini, QIAsprint Connect and QIAsymphony Connect, we are supporting customers with new ways to tackle complex challenges – from liquid biopsy to high-throughput screening – with smart, scalable solutions." These upcoming launches build on recent enhancements across QIAGEN's automation portfolio, including the upgraded QIAcube Connect and EZ2 Connect systems. Together, they reflect QIAGEN's strategy to provide modular, scalable solutions in sample preparation that match evolving lab needs from small research settings to high-volume testing labs. To learn more about QIAGEN's portfolio of instruments for automated sample preparation, please visit: About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. Further information can be found at Forward-Looking Statement Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading "Risk Factors in our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission. Source: QIAGEN N.V. Category: Life Sciences View source version on Contacts QIAGEN Investor Relations John Gilardi, +49 2103 29 11711Domenica Martorana, +49 2103 29 11244e-mail: ir@ Public Relations Thomas Theuringer, +49 2103 29 11826Lisa Specht, +49 2103 29 14181e-mail: pr@ Sign in to access your portfolio
Yahoo
13-02-2025
- Business
- Yahoo
QIAGEN Strengthens Global Bioinformatics Leadership With New Data Center in Australia/Asia-Pacific Region
New facility reflects QIAGEN's commitment to enhancing its bioinformatics data center infrastructure in the Australia, New Zealand, New Guinea and surrounding islands region New data center in Melbourne meets Australian regulations to ensure quality, scalable and trustworthy support for Omics analysis and interpretation in genomic testing labs Expands a QIAGEN network of seven data centers around the globe designed to ensure highest level of data security, compliance and operational excellence worldwide VENLO, The Netherlands & REDWOOD CITY, Calif., February 13, 2025--(BUSINESS WIRE)--QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the official opening of a new data center in Melbourne, Australia, designed to strengthen its global bioinformatics leadership position in this region of the world. This latest addition reflects QIAGEN's ongoing commitment to enhance its bioinformatics data infrastructure, enabling initiatives to broaden the reach and use of bioinformatics products in the Australia/Asia-Pacific region – which encompasses Australia, New Zealand, New Guinea and surrounding islands. It will also expand the current QIAGEN network of seven data centers strategically located across the United States, United Kingdom, Denmark, Turkey, South Korea, Japan and China. This investment supports the expanding data center market in the Australia/Asia-Pacific region while ensuring local compliance and high-quality solutions for Omics analysis and interpretation in genomic testing laboratories. The new Melbourne facility will provide in-country data hosting, supporting genomic testing labs in Australia to securely host sensitive data while complying with Australian privacy and health data regulations. It underscores QIAGEN's commitment to providing tailored bioinformatics solutions that enable secure, efficient and innovative clinical and diagnostic services. "With the opening of this data center, we are strengthening our ability to serve the Australian market and the broader Australia/Asia-Pacific region," said Dominic John, Vice President, QIAGEN Digital Insights. "This new facility will allow diagnostic labs to confidently deliver clinical next-generation sequencing testing services while meeting evolving data sovereignty laws. Now operating eight data centers around the globe, we are ensuring data security, compliance and operational excellence worldwide." As the use of clinical next-generating sequencing (NGS) continues to evolve, QIAGEN remains at the forefront, delivering innovative bioinformatics solutions that empower labs and researchers to unlock the full potential of genomics and personalized medicine. With over 25 years of experience in the industry, 90,000 users worldwide, and 4 million profiled patient cases, QDI is committed to accelerating breakthroughs in science and healthcare by providing intuitive, scalable solutions that transform complex biological information into clear, actionable insights. For more information about QIAGEN Digital Insights and its global data infrastructure, visit About QIAGEN QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit Forward-Looking Statement Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN's products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results - such as expected adjusted net sales and adjusted diluted earnings - are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN's products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN's products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other "force majeure" events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the "Risk Factors" contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission. Source: QIAGEN N.V. Category: Corporate View source version on Contacts Contacts QIAGEN: Investor Relations John Gilardi +49 2103 29 11711Domenica Martorana +49 2103 29 11244e-mail: ir@ Public Relations Thomas Theuringer +49 2103 29 11826Lisa Specht +49 2103 29 14181e-mail: pr@ Sign in to access your portfolio
