FDA Clearance and Product Innovation - The US FDA has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use, marking the fourth QIAstat-Dx syndromic test to receive US regulatory clearance in 2024 [1] - The QIAstat-Dx Meningitis/Encephalitis Panel leverages real-time PCR technology to simultaneously analyze multiple genetic targets, providing results in about one hour, compared to traditional methods that require at least 24 hours [2][3] - The QIAstat-Dx system provides cycle threshold (Ct) values and amplification curves, offering additional clinical information not available with traditional end-point PCR or other techniques [4] Market and Industry Context - Bacterial meningitis cases in the US have reached their highest levels since 2014, with case numbers varying by state depending on vaccination rates [2] - Many US healthcare facilities still rely on traditional microbiological testing, which lacks sensitivity and requires longer processing times [2] - The QIAstat-Dx system addresses the need for rapid, evidence-based diagnostics in community-acquired meningitis and encephalitis, which are medical emergencies requiring immediate treatment [3] Product Portfolio and Operational Efficiency - The QIAstat-Dx Meningitis/Encephalitis Panel is the fourth FDA-cleared QIAstat-Dx panel in 2024, following clearances for the Gastrointestinal Panel 2, Respiratory Panel Plus, and Respiratory Panel Mini [4] - All QIAstat-Dx panels are available as cost-efficient, single-use cartridges that simplify test setup, requiring less than a minute and no precision pipetting [4] - The system’s software interprets signals from the reaction and provides positive or negative results for each pathogen, offering one of the simplest workflows for syndromic testing on the market [4] Company Overview - QIAGEN is a Netherlands-based holding company and a leading global provider of Sample to Insight solutions, enabling molecular insights from biological samples [6] - The company serves over 500,000 customers worldwide in Molecular Diagnostics and Life Sciences, with more than 5,900 employees across over 35 locations as of June 30, 2024 [6][7]

Germantown, Maryland, and Venlo, the Netherlands, Oct. 29, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Mini test for clinical use. It is the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024. The QIAstat-Dx Respiratory Panel Mini is designed to support clinical decision making in diagnosing upper respiratory infections in outpatient settings ...

Venlo, The Netherlands, Oct. 10, 2024 (GLOBE NEWSWIRE) -- QIAGEN N.V. (NYSE: QGEN) (Frankfurt Stock Exchange: QIA) announced plans to release results for the third quarter 2024. Press release date / time: Wednesday, November 6, shortly after 22:05 Frankfurt time / 21:05 London time / 16:05 New York time. Conference call date / time: Thursday, November 7, at 15:30 Frankfurt time / 14:30 London time / 09:30 New York time. Three options for joining the conference call Register for call back connection - Click ...

QIAGEN N.V. (QGEN) is well-poised to grow in the coming quarter, driven by its strategic alliances with researchers and pharma companies. The company's expansive next-generation sequencing (NSG) portfolio continues to be bolstered by several innovations. Meanwhile, QIAGEN's operations are vulnerable to currency fluctuations, which can adversely affect its financial results. Competitive disadvantages also add to the worry. In the past year, this Zacks Rank #3 (Hold) stock has risen 6% compared with 4% growth ...

Venlo, the Netherlands, Sept. 26, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR). This certification includes the widely-used QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The achievement underscores QIAGEN's commitment to meeti ...

QIAGEN N.V.(QGEN) and Becton, Dickinson and Company or BD's (BDX) joint venture, PreAnalytiX GmbH, recently launched the PAXgene Urine Liquid Biopsy Set. PAXgene will be used for reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS). QIAGEN will commercialize the newly launched set with the first verified, standardized and complete preanalytical workflow from urine collection, stabilization and isolati ...

QIAGEN N.V. (QGEN) recently announced that Bode Technology will be the exclusive global commercial partner for its GEDmatch PRO genealogy database. QIAGEN's subsidiary Verogen inked the deal with Bode. The company has been providing GEDmatch PRO to customers since the acquisition of its subsidiary, Verogen, in early 2023. The latest partnership is aimed at accelerating the use of QIAGEN's next-generation sequencing (NGS) products in human identification (HID) and forensic investigations. QGEN's Likely Stock ...

Venlo, the Netherlands, and Germantown, Maryland, Sept. 23, 2024 (GLOBE NEWSWIRE) -- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that Bode Technology, the largest private U.S. forensics laboratory company with a growing presence in other regions, would become the exclusive global commercial partner for the GEDmatch PRO genealogy database, which is used to assist police and forensic teams with investigative comparisons of genetic data. The multi-year agreement between QIAGEN's sub ...

QIAGEN N.V. (QGEN) recently announced the launch of 100 new assays for its digital polymerase chain reaction (dPCR) platform — QIAcuity. The assays will be used to study cancer, inherited genetic disorders, infectious disease surveillance, and food and environmental monitoring. These are available through QIAGEN's comprehensive GeneGlobe platform. The latest launch will be an addition to the company's PCR product portfolio. QGEN's Likely Stock Trend Following the News Shares of QGEN were up 0.04% in pre-mar ...

Venlo, the Netherlands, Sept. 18, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an important milestone with the launch of 100 new assays for its digital PCR (dPCR) platform QIAcuity for use in the study of cancer, inherited genetic disorders, infectious disease surveillance, and food and environmental monitoring. These new assays are available through QIAGEN's comprehensive GeneGlobe platform which integrates predesigned assays with a database of more than 10,00 ...