QIAGEN receives FDA clearance of QIAstat-Dx meningitis/encephalitis panel to support emergency diagnostics
QIAGEN has received FDA clearance for its QIAstat-Dx Meningitis/Encephalitis Panel, marking its fourth FDA clearance in 2024. The panel enables rapid diagnosis of central nervous system infections, delivering results in about one hour using real-time PCR technology, compared to traditional methods requiring 24+ hours. The test simultaneously analyzes common viral, bacterial, and fungal pathogens responsible for community-acquired meningitis/encephalitis. This approval expands QIAGEN's FDA-cleared test menu, which now covers respiratory, gastrointestinal, and central nervous system infections. The system offers unique features including cycle threshold values and amplification curves for enhanced clinical information.
QIAGEN ha ricevuto l'approvazione della FDA per il suo QIAstat-Dx Meningitis/Encephalitis Panel, segnando la sua quarta approvazione FDA nel 2024. Questo pannello consente una diagnosi rapida delle infezioni del sistema nervoso centrale, fornendo risultati in circa un'ora grazie alla tecnologia PCR in tempo reale, rispetto ai metodi tradizionali che richiedono oltre 24 ore. Il test analizza contemporaneamente i principali patogeni virali, batterici e fungini responsabili delle meningiti/encefaliti acquisiti nella comunità. Questa approvazione amplia l'offerta di test approvati dalla FDA di QIAGEN, che ora copre infezioni respiratorie, gastrointestinali e del sistema nervoso centrale. Il sistema offre funzionalità uniche, inclusi i valori di soglia nei cicli e le curve di amplificazione per un'informazione clinica migliorata.
QIAGEN ha recibido la autorización de la FDA para su QIAstat-Dx Meningitis/Encephalitis Panel, lo que marca su cuarta aprobación por parte de la FDA en 2024. Este panel permite un diagnóstico rápido de las infecciones del sistema nervioso central, proporcionando resultados en aproximadamente una hora usando tecnología PCR en tiempo real, en comparación con los métodos tradicionales que requerían más de 24 horas. La prueba analiza simultáneamente los patógenos virales, bacterianos y fúngicos comunes responsables de la meningitis/encefalitis adquirida en la comunidad. Esta aprobación amplía el menú de pruebas autorizadas por la FDA de QIAGEN, que ahora cubre infecciones respiratorias, gastrointestinales y del sistema nervioso central. El sistema ofrece características únicas, incluyendo valores de umbral de ciclo y curvas de amplificación para una información clínica mejorada.
QIAGEN는 QIAstat-Dx Meningitis/Encephalitis 패널에 대한 FDA 승인을 받았으며, 이는 2024년의 네 번째 FDA 승인입니다. 이 패널은 중앙 신경계 감염의 신속한 진단을 가능하게 하여 실시간 PCR 기술을 사용하여 약 1시간 만에 결과를 제공합니다. 이는 전통적인 방법이 24시간 이상 소요되는 것과 비교됩니다. 이 테스트는 지역 사회에서 발생하는 수막염 및 뇌염의 원인인 일반적인 바이러스, 박테리아 및 곰팡이 병원체를 동시에 분석합니다. 이 승인은 현재 호흡기, 위장관 및 중앙 신경계 감염을 포함하는 QIAGEN의 FDA 승인 테스트 메뉴를 확장합니다. 시스템은 임상 정보를 향상시키기 위한 사이클 임계값 및 증폭 곡선과 같은 고유한 기능을 제공합니다.
QIAGEN a reçu l'approbation de la FDA pour son QIAstat-Dx Meningitis/Encephalitis Panel, marquant son quatrième approbation FDA en 2024. Ce panel permet un diagnostic rapide des infections du système nerveux central, fournissant des résultats en environ une heure grâce à la technologie PCR en temps réel, par rapport aux méthodes traditionnelles qui nécessitent plus de 24 heures. Le test analyse simultanément les agents pathogènes viraux, bactériens et fongiques courants responsables de la méningite / encéphalite acquise dans la communauté. Cette approbation élargit le menu des tests approuvés par la FDA de QIAGEN, qui couvre désormais les infections respiratoires, gastrointestinales et du système nerveux central. Le système offre des fonctionnalités uniques, y compris des valeurs de seuil de cycle et des courbes d'amplification pour des informations cliniques améliorées.
QIAGEN hat von der FDA die Genehmigung für sein QIAstat-Dx Meningitis/Encephalitis Panel erhalten, was die vierte Genehmigung der FDA im Jahr 2024 darstellt. Das Panel ermöglicht eine schnelle Diagnose von Infektionen des zentralen Nervensystems und liefert Ergebnisse in etwa einer Stunde mittels Echtzeit-PCR-Technologie, im Vergleich zu traditionellen Methoden, die mehr als 24 Stunden benötigen. Der Test analysiert gleichzeitig gängige virale, bakterielle und fungale Erreger, die für die in der Gemeinschaft erworbene Meningitis/Encephalitis verantwortlich sind. Diese Genehmigung erweitert das von der FDA genehmigte Testangebot von QIAGEN, das nun Atemwegs-, Magen-Darm- und zentrale Nervensysteminfektionen abdeckt. Das System bietet einzigartige Funktionen, einschließlich Zyklusschwellenwerte und Verstärkungskurven für verbesserte klinische Informationen.
- Fourth FDA clearance in 2024, expanding product portfolio
- Significant time reduction in test results (1 hour vs 24+ hours)
- Superior technology offering additional clinical information through Ct values
- Simple workflow with pre-loaded cartridges requiring minimal setup time
- None.
Insights
The FDA clearance of QIAGEN's QIAstat-Dx Meningitis/Encephalitis Panel represents a significant advancement in diagnostic capabilities for critical central nervous system infections. The test's one-hour turnaround time, compared to traditional 24-hour methods, could substantially improve patient outcomes in emergency situations where rapid treatment is crucial. The timing is particularly relevant given that bacterial meningitis cases in the U.S. are at their highest levels since 2014.
The panel's ability to simultaneously detect multiple pathogens while providing Ct values and amplification curves offers superior clinical utility compared to traditional methods. This marks QIAGEN's fourth FDA clearance in 2024, demonstrating strong momentum in expanding their diagnostic portfolio. The test's simplified workflow and comprehensive pathogen coverage position it well for adoption in clinical settings, particularly in emergency departments where quick, accurate diagnostics are essential.
This FDA clearance strengthens QIAGEN's market position in the rapidly growing syndromic testing segment. With four FDA clearances in 2024, QIAGEN is executing well on its strategy to expand its diagnostic portfolio. The QIAstat-Dx platform's expanding test menu enhances its competitive position against rivals and increases its value proposition to healthcare facilities.
The recurring revenue model from single-use cartridges, combined with the platform's expanding capabilities, should drive sustained growth in QIAGEN's molecular diagnostics business. The timing is particularly advantageous given the rising incidence of bacterial meningitis cases, which could accelerate adoption in U.S. healthcare facilities still using traditional testing methods.
QIAstat-Dx Meningitis/Encephalitis Panel cleared in the U.S. for use in clinical settings to help diagnose central nervous system infections // Fourth FDA clearance marks milestone in 2024 in successful expansion of QIAstat‑Dx tests developed specifically for the U.S. // QIAGEN now offers broad menu with FDA-cleared tests for respiratory, gastrointestinal and central nervous system infections – and plans for further expansion // QIAstat-Dx delivers results in about one hour with real-time PCR, ensuring fast and accurate results to support clinical decision-making
Germantown, Maryland, and Venlo, the Netherlands, Nov. 04, 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 Meningitis/Encephalitis Panel for clinical use.
This marks the fourth QIAstat-Dx syndromic test to receive U.S. regulatory clearance in 2024.
Meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain) are medical emergencies that require immediate treatment. One in five cases of bacterial meningitis results in permanent complications, such as hearing loss, brain damage and seizures and without prompt treatment, about half of patients will die.[1]
Bacterial meningitis cases in the United States have reached their highest levels since 2014, with case numbers varying from state to state depending on vaccination rates.[2]
Many U.S. healthcare facilities still rely solely on traditional microbiological testing, which often requires samples to be incubated for at least 24 hours compared to QIAstat-Dx delivering results in about one hour. Traditional methods also lack sensitivity, which is critical given that only a small amount of cerebrospinal fluid (CSF) is collected from a patient for testing.
“Community-acquired meningitis and encephalitis can progress rapidly, and that means healthcare providers need evidence-based diagnostics that can help them make rapid treatment decisions. The QIAstat-Dx Meningitis/Encephalitis Panel addresses many challenges faced by clinicians and streamlines the process so they can get timely and accurate results in about one hour,” said Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “This marks the fourth FDA clearance for a QIAstat-Dx test in 2024, and a signal of our commitment to expanding our test menu in the U.S. as well as around the world.”
The QIAstat-Dx Meningitis/Encephalitis Panel leverages the system’s ability to quickly amplify many genetic targets at the same time using real-time PCR technology. The QIAstat-Dx panel simultaneously analyzes several of the most common viral, bacterial and fungal pathogens responsible for community-acquired meningitis/encephalitis.
The QIAstat-Dx system is also unique in that results include cycle threshold (Ct) values and amplification curves, which offer immediately viewable information for detected pathogens and provide healthcare professionals with additional clinical information not available with end-point PCR or other techniques.
This new panel marks the fourth FDA clearance of a QIAstat-Dx panel in 2024, and comes after the recent FDA clearances for other tests:
- QIAstat-Dx Gastrointestinal Panel 2
- QIAstat-Dx Respiratory Panel Plus
- QIAstat-Dx Respiratory Panel Mini
All QIAstat-Dx panels are available as cost-efficient, single-use cartridges that slot easily into the QIAstat-Dx instrument. All reagents are preloaded into the cartridge, enabling the test set-up to be completed in less than a minute and requires no precision pipetting. Software interprets signals from the reaction and provides positive or negative results for each pathogen, providing clinicians with one of the simplest workflows for syndromic testing on the market.
Learn more about QIAstat-Dx at https://www.qiagen.com/products/diagnostics-and-clinical-research/infectious-disease/qiastat-dx-syndromic-testing/qiastat-dx-na.
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 June 30, 2024, QIAGEN employed more than 5,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
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, including those products used in the response to the COVID-19 pandemic, 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, including the breadth and duration of the COVID-19 pandemic 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” contained in Item 3 of 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: Corporate
[1] https://www.who.int/news-room/fact-sheets/detail/meningitis, as of October 30, 2024
[2] https://www.cdc.gov/meningococcal/php/surveillance/index.html, as of October 30, 2024
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