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QIAGEN N.V. (symbol: QGEN) is a leading global provider of sample-to-insight solutions that transform biological materials into valuable molecular insights. The company's sample technologies isolate and process DNA, RNA, and proteins from blood, tissue, and other materials. Its assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases from QIAGEN interpret data to report relevant, actionable insights. Automation solutions tie these components together in seamless and cost-effective molecular testing workflows.
QIAGEN serves a diverse customer base of over 500,000 worldwide in sectors such as molecular diagnostics (human healthcare), applied testing (forensics, veterinary testing, and food safety), pharma (pharmaceutical and biotechnology companies), and academia (life sciences research). As of June 30, 2015, the company employed approximately 4,400 people across 35 locations globally. Additional information can be found on their website at http://www.qiagen.com.
QIAGEN's proprietary sample and assay technology enables the extraction, purification, amplification, and interpretation of DNA, RNA, and proteins. The company's revenue is almost evenly split between life sciences and molecular diagnostics applications, with nearly 90% of its revenue derived from consumables and the remaining from instrumentation and related services. The largest portion of QIAGEN's revenue comes from the Americas (over 45% of 2022 sales), followed by EMEA (nearly 35%), and Asia-Pacific (nearly 20%).
Recent achievements include:
- Q1 2024 net sales of $459 million (-5% at actual rates, -5% at constant exchange rates, CER), with a diluted EPS of $0.36 and an adjusted diluted EPS of $0.46. The net sales at CER of $462 million were ahead of the outlook for at least $455 million CER, and the adjusted diluted EPS of $0.47 CER was ahead of the $0.44 CER outlook.
- Strong operating cash flow rose by 85% to $133 million versus Q1 2023.
- The QCI Secondary Analysis software, integrated with QCI Interpret, facilitates high-throughput secondary analysis of clinical next-generation sequencing data.
- Collaborations aimed at creating novel digital PCR assays to improve DNA analysis in forensics and human identification.
- Introduction of the QIAstat-Dx Respiratory Panel Plus for accurate diagnosis of respiratory infections, capable of generating results in about one hour with minimal hands-on time.
- Enhancements to the QIAGEN Clinical Insight Interpret platform, which has processed over 4 million NGS patient test cases for oncology and hereditary diseases worldwide.
- New QIAcuity digital PCR Custom Assay Design Tool for copy number variation analysis, complementing the company's existing assay offerings.
QIAGEN continues to innovate and maintain its leading position in the molecular diagnostics and life sciences industries. The company's ongoing efforts to expand its product offerings and enhance its technologies ensure that it remains a trusted partner for researchers and healthcare providers worldwide.
QIAGEN is sponsoring the annual Global TB Summit from October 8-11, 2024, addressing the resurgence of tuberculosis as a leading infectious killer. The event will gather thousands of healthcare professionals, advocates, and policymakers from over 170 countries. Key points include:
- TB incident rate rose by 3.9% in 2022, with 10.6 million people falling ill and 1.3 million deaths
- QIAGEN's QuantiFERON-TB Gold Plus test plays a important role in detecting latent TB infection
- Over 35 top TB experts will discuss advancements in diagnostics and new treatment strategies
- The summit offers CPD and CME credits and emphasizes the need for renewed global efforts in TB control
- Topics include global and regional TB updates, challenges in special populations, and socioeconomic factors influencing TB
The event aims to foster collaboration and innovation in the fight against TB, with a focus on early detection and prevention strategies.
Neogen (NASDAQ: NEOG) has announced the appointment of Thierry Bernard as a new director to its Board, effective November 1, 2024. Bernard, the current CEO of QIAGEN N.V., brings extensive experience in science and technologies relevant to Neogen's markets. Jim Borel, Neogen's Board Chair, expressed confidence that Bernard's expertise will provide significant value during the company's continued growth.
Bernard has been CEO of QIAGEN since March 2020, after joining the company in 2015. His prior experience includes 15 years at bioMérieux SA, where he held various senior roles, including Corporate Vice President of Global Commercial Operations, Investor Relations, and the Greater China Region. This appointment aligns with Neogen's commitment to enhancing global food security.
QIAGEN has launched the QIAcuityDx Digital PCR System, expanding its digital PCR portfolio into clinical diagnostics. The system is 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe. It provides precise, absolute quantitation of target DNA and RNA, supporting liquid biopsy applications and cancer monitoring.
Key features of QIAcuityDx include:
- All-in-one instrument for IVD assays and lab-designed tests
- User-friendly software with IVD and Utility modes
- Flexible scheduling and continuous sample loading
- Processing of up to four nanoplates simultaneously
- Reduced lab space requirements and processing times
QIAGEN plans to expand the application menu, with a BCR::ABL assay for oncohematology planned for FDA submission in 2025. The company has also signed three partnerships for companion diagnostics development.
QIAGEN has received CE-marking under the new European Union IVDR framework for its QIAstat-Dx syndromic testing systems and assays. This certification includes the QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The achievement highlights QIAGEN's commitment to meeting high safety, quality, and performance standards, with 80% of over 180 products already transitioned to the new regulatory framework.
The QIAstat-Dx system uses multiplex real-time PCR technology to rapidly detect multiple pathogens simultaneously, delivering results in about one hour. By the end of 2023, more than 4,000 QIAstat-Dx systems had been installed globally, available in over 100 countries. The system is valued for its ease of use and reliable detection of various pathogens, contributing to better patient outcomes and antimicrobial stewardship.
PreAnalytiX, a joint venture between QIAGEN and BD, has launched the PAXgene Urine Liquid Biopsy Set, a novel solution for liquid biopsy from urine samples. This set enables non-invasive sample collection and direct cell-free DNA (cfDNA) stabilization from urine, addressing the challenge of accessing cfDNA through an integrated preservation solution.
The set features a verified, standardized, and complete preanalytical workflow for urine cfDNA analysis, compatible with various molecular testing technologies. QIAGEN will commercialize the set, which complements their existing liquid biopsy solutions. The PAXgene Urine Liquid Biopsy Set offers improved sample quality, standardization, and convenience for researchers working with urine samples, and has been developed according to Europe's latest CEN/TS standard for preanalytical handling of urine for isolated cell-free DNA.
QIAGEN (NYSE: QGEN) has announced a partnership with Bode Technology, making Bode the exclusive global commercial partner for the GEDmatch PRO genealogy database. This database assists police and forensic teams with investigative comparisons of genetic data. The multi-year agreement aims to accelerate the use of GEDmatch PRO in law enforcement and identification of human remains.
Key points of the partnership include:
- Bode will manage all commercial transactions for GEDmatch PRO globally
- QIAGEN will continue developing new features with input from Bode's genealogy experts
- The partnership leverages QIAGEN's expertise in forensic products and Bode's forensic services
- It will boost the use of QIAGEN's next-generation sequencing (NGS) products in human identification and forensic investigations
This collaboration is expected to enhance the adoption of extensive DNA data in solving cold cases and bring resolution to victims' families and friends.
QIAGEN (NYSE: QGEN) has expanded its QIAcuity digital PCR platform with over 100 new assays for cancer research, genetic disorders, and infectious disease surveillance. The company has launched more than 130 new assays in 2024, surpassing its goal and bringing the total to over 2,300 validated assays.
Key developments include:
- New dPCR LNA Mutation and CNV Probe Assays for cancer-relevant mutations
- dPCR Microbial DNA Detection Assays for pathogens and antibiotic resistance
- Expanded portfolio for animal diseases and plant pathogens
QIAcuity has seen strong adoption with over 2,000 placements by end of 2023. An in-vitro diagnostic version is set for launch in fall 2024, targeting clinical applications. QIAGEN is also partnering with pharma companies to develop companion diagnostics on the platform.
QIAGEN (NYSE: QGEN) has expanded its strategic partnership with Bio-Manguinhos/Fiocruz, Brazil's leading provider of vaccines and diagnostics. The collaboration enhances Brazil's national blood screening program with advanced PCR-based molecular testing for malaria, HIV, hepatitis B, and C. Additionally, it supports epidemiological surveillance of Brazil's ongoing dengue outbreak.
The new NAT Plus platform, utilizing QIAGEN's PCR reagents, is now operational in 30 laboratories across Brazil, processing 3.5 million samples annually. This advancement significantly improves transfusional safety by detecting malaria and reducing the diagnostic window for infections. QIAGEN will provide critical molecular biology technologies, custom solutions, and comprehensive training to support this public health initiative.
QIAGEN (NYSE: QGEN) has announced a collaboration with Eli Lilly to develop a QIAstat-Dx in-vitro diagnostic (IVD) panel for APOE genotyping, which can aid in the diagnosis of Alzheimer's disease. This marks the first commercially available IVD for APOE genotyping and expands QIAstat-Dx's applications into neurodegenerative diseases.
The QIAstat-Dx system, with over 4,000 instruments worldwide, uses single-use cartridges and multiplex real-time PCR to detect genetic variants in about an hour. The new panel will detect all APOE genotypes (APOE2, APOE3, APOE4), with APOE4 carriers having a higher risk of developing Alzheimer's earlier in life.
This collaboration adds to QIAGEN's portfolio of over 30 master agreements with pharmaceutical and biotech companies for diagnostic test development across various technologies and disease areas.
QIAGEN has expanded its partnership with AstraZeneca to develop and commercialize companion diagnostics (CDx) for chronic diseases using the QIAstat-Dx platform. This agreement extends their collaboration beyond oncology, enabling fast decision-making for patient suitability for AstraZeneca's genomically targeted medicines. QIAGEN will develop a genotyping assay for the QIAstat-Dx system, which can provide results in about an hour using multiplex real-time PCR technology.
The QIAstat-Dx platform, with over 4,000 cumulative instrument placements by the end of 2023, offers cost-efficient, single-use cartridges and provides additional insights through cycle threshold values and amplification curves. This expansion showcases QIAGEN's expertise in CDx development and its ability to tailor products to partners' needs across various technologies, including PCR, digital PCR, and next-generation sequencing.
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