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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 has launched the QIAstat-Dx Gastrointestinal Panel 2 in the U.S. following FDA clearance for clinical use. The panel identifies up to 16 GI pathogens in about an hour using real-time PCR technology, improving the efficiency and accuracy of GI infection diagnoses. Acute infectious gastroenteritis is a major health concern in the U.S., with 180 million cases annually. The panel's rapid detection reduces the need for lengthy traditional tests and helps healthcare providers quickly isolate contagious patients. Additionally, it supports antimicrobial stewardship by reducing unnecessary antibiotic use. The QIAstat-Dx system is widely used with over 4,000 installations globally, and it features cloud-based connectivity for remote monitoring and epidemiological insights.
QIAGEN and Myriad Genetics have announced a collaboration to develop a kit-based test for Homologous Recombination Deficiency (HRD). This next-generation sequencing (NGS) test leverages QIAGEN’s QIAseq xHYB technology and Myriad’s FDA-approved MyChoice CDx biomarkers.
The test will support research and companion diagnostics development, aiding personalized medicine for ovarian and other solid tumors. The goal is to enhance decentralized testing, reduce therapy decision times, and lower associated costs.
The MyChoice CDx assay can identify 34% more HRD tumors compared to other methods. This initiative builds on a recently announced collaboration agreement and aims to expand the accessibility and clinical adoption of HRD testing globally.
QIAGEN has introduced its QIAseq Multimodal DNA/RNA Lib Kit, designed to streamline the preparation of DNA and RNA libraries from a single sample for next-generation sequencing (NGS). This new kit aids multiomics studies, important for precision medicine and understanding complex diseases like cancer.
It offers a simplified workflow for whole genome and transcriptome sequencing, reducing sample material and time required. The kit supports various sample types, including blood, FFPE samples, and cfDNA, and is compatible with multiple sequencing platforms, such as Illumina and Element Aviti.
The QIAseq Multimodal Kit's flexibility in generating DNA-only or RNA-only libraries, as well as combined DNA/RNA libraries, enhances efficiency and saves resources in NGS labs. The kit adds to QIAGEN's NGS technology portfolio, which is pivotal in biomarker research and disease surveillance.
QIAGEN has received European IVDR certification for its QIAGEN Clinical Insight Interpret, a clinical decision support software for next-generation sequencing (NGS) in oncology and hereditary applications. This certification ensures the platform complies with the EU's regulatory framework, enhancing patient safety, data transparency, and traceability. The software has already processed over 4 million NGS patient test cases globally. The certified version will be available in Europe by late 2024, facilitating faster and more accurate clinical decision-making.
QIAGEN has received FDA clearance for its QIAstat-Dx Respiratory Panel Plus, a syndromic test for diagnosing upper respiratory infections. The panel covers 21 viral and bacterial targets, delivers results in about an hour with minimal hands-on time, and provides access to Ct values and amplification curves. This technology aims to improve patient care, support antimicrobial stewardship, and reduce healthcare system burden. QIAGEN is expanding its testing menu, with a Gastrointestinal Panel under FDA review. The company also launched the QIAstat-Dx Analyzer 2.0, featuring cloud-based connectivity and remote result access, enhancing collaboration in healthcare.
QIAGEN partners with the FBI to develop a novel digital PCR assay for QIAcuity to enhance DNA analysis in forensics, improving accuracy, speed, and reliability in human identification. The collaboration aims to quantify DNA from human samples for forensic use, strengthening QIAGEN's leadership in human identification and forensics.
QIAGEN has launched QCI Secondary Analysis, a cloud-based software solution that enhances bioinformatics workflows for oncology and inherited disease applications. The software, integrated with QCI Interpret, enables high-throughput secondary analysis of clinical next-generation sequencing data, advancing precision medicine and making NGS testing accessible to smaller labs. The solution provides a secure and compliant environment for bioinformatics workflows, supporting all QIAGEN QIAseq panels.
QIAGEN reported its Q1 2024 results, showcasing net sales of $459 million with a 5% decline, but exceeded expectations with $462 million at constant exchange rates. The company's adjusted operating income margin rose to 25.7% from 25.6% in Q1 2023, with adjusted diluted EPS at $0.46, above the outlook of $0.44. Key growth drivers include double-digit CER growth in QuantiFERON and QIAstat-Dx, resulting in a positive outlook for 2024 with reaffirmed guidance of at least $2.0 billion in net sales and adjusted diluted EPS of at least $2.10 CER.
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