QIAGEN receives FDA clearance for QIAstat-Dx mini panel to improve precision in outpatient respiratory treatment
QIAGEN has received FDA clearance for its QIAstat-Dx Respiratory Panel Mini test, marking its third FDA clearance in 2024. The test targets five key respiratory pathogens: influenza A, influenza B, human rhinovirus, RSV, and SARS-CoV-2. It delivers results in about one hour with minimal hands-on time using real-time PCR technology. This complements the previously cleared 21-target QIAstat-Dx Respiratory Panel Plus, offering clinicians flexibility between comprehensive and targeted testing approaches. The Mini panel is specifically designed for outpatient settings, while the Plus panel suits hospitalized patients with severe disease risk factors.
QIAGEN ha ricevuto l'approvazione della FDA per il suo test QIAstat-Dx Respiratory Panel Mini, segnando la sua terza approvazione FDA nel 2024. Il test si concentra su cinque patogeni respiratori principali: influenza A, influenza B, rhinovirus umano, RSV e SARS-CoV-2. Fornisce risultati in circa un'ora con un tempo di manodopera minimo utilizzando la tecnologia PCR in tempo reale. Questo integra il precedente pannello QIAstat-Dx Respiratory Panel Plus, approvato per 21 target, offrendo ai clinici flessibilità tra approcci di test completi e mirati. Il pannello Mini è specificamente progettato per contesti ambulatoriali, mentre il pannello Plus è adatto per pazienti ricoverati con fattori di rischio per malattie gravi.
QIAGEN ha recibido la aprobación de la FDA para su prueba QIAstat-Dx Respiratory Panel Mini, marcando su tercera aprobación de la FDA en 2024. La prueba se dirige a cinco patógenos respiratorios clave: influenza A, influenza B, rinovirus humano, RSV y SARS-CoV-2. Proporciona resultados en aproximadamente una hora con un tiempo de manipulación mínimo utilizando tecnología de PCR en tiempo real. Esto complementa el previamente aprobado panel respiratorio QIAstat-Dx Panel Plus de 21 objetivos, ofreciendo a los clínicos flexibilidad entre enfoques de pruebas completos y dirigidos. El panel Mini está diseñado específicamente para entornos ambulatorios, mientras que el panel Plus es adecuado para pacientes hospitalizados con factores de riesgo de enfermedades graves.
QIAGEN은 QIAstat-Dx Respiratory Panel Mini 테스트에 대한 FDA 승인을 받았으며, 이는 2024년 FDA 승인 중 세 번째입니다. 이 테스트는 주요 호흡기 병원체인 인플루엔자 A, 인플루엔자 B, 인간 라이노바이러스, RSV 및 SARS-CoV-2를 목표로 합니다. 이 테스트는 실시간 PCR 기술을 사용하여 약 1시간 이내에 최소한의 수작업으로 결과를 제공합니다. 이는 21개의 타겟을 포함하는 이전에 승인된 QIAstat-Dx Respiratory Panel Plus와 보완적으로 작용하여 임상의에게 포괄적 및 표적 검사 접근 방식 간의 유연성을 제공합니다. Mini 패널은 외래 환자 환경에 특별히 설계되었으며, Plus 패널은 중증 질환 위험 인자가 있는 입원 환자들에게 적합합니다.
QIAGEN a obtenu l'autorisation de la FDA pour son test QIAstat-Dx Respiratory Panel Mini, ce qui marque sa troisième autorisation de la FDA en 2024. Ce test cible cinq agents pathogènes respiratoires clés : influenza A, influenza B, rhinovirus humain, RSV et SARS-CoV-2. Il fournit des résultats en environ une heure avec un temps de manipulation minimal en utilisant la technologie PCR en temps réel. Cela complète le QIAstat-Dx Respiratory Panel Plus précédemment approuvé, qui comprend 21 cibles, offrant ainsi aux cliniciens une flexibilité entre approches de tests complets et ciblés. Le panneau Mini est spécifiquement conçu pour les milieux de soins ambulatoires, tandis que le panneau Plus convient aux patients hospitalisés présentant des facteurs de risque de maladie grave.
QIAGEN hat die FDA-Zulassung für seinen Test QIAstat-Dx Respiratory Panel Mini erhalten, was die dritte FDA-Zulassung im Jahr 2024 darstellt. Der Test richtet sich gegen fünf wichtige Atemwegserreger: Influenza A, Influenza B, humane Rhinoviren, RSV und SARS-CoV-2. Die Ergebnisse werden in etwa einer Stunde mit minimalem Aufwand unter Verwendung der Echtzeit-PCR-Technologie bereitgestellt. Dies ergänzt das zuvor zugelassene 21-Ziel-QIAstat-Dx Respiratory Panel Plus und bietet den Klinikern Flexibilität zwischen umfassenden und gezielten Testansätzen. Das Mini-Panel ist speziell für ambulante Einrichtungen ausgelegt, während das Plus-Panel für hospitalisierte Patienten mit schweren Krankheitsrisikofaktoren geeignet ist.
- Third FDA clearance for QIAstat-Dx in 2024, showing strong regulatory momentum
- Quick test results in about one hour with less than one minute hands-on time
- Expanded market reach with over 4,000 instruments placed worldwide across 100+ countries
- Product portfolio expansion with new analyzer and panel variants
- FDA clearance for QIAstat-Dx Rise higher-capacity version delayed until 2025
Insights
The FDA clearance of QIAstat-Dx Respiratory Panel Mini represents a significant advancement in diagnostic testing. This streamlined 5-target panel, focusing on the most common respiratory pathogens, fills a important market gap for outpatient settings where rapid, targeted testing is essential. The one-hour turnaround time and minimal hands-on requirements address key efficiency demands in busy clinical environments.
The strategic positioning of two distinct panels - the Mini for outpatient and the 21-target Plus for inpatient use - demonstrates strong market segmentation and potential revenue growth. The expanded QIAstat-Dx portfolio, including the new Analyzer 2.0 and planned submissions for additional panels, suggests a robust product pipeline that could drive substantial market penetration. With over 4,000 instruments placed worldwide and presence in more than 100 countries, QIAGEN is well-positioned to capitalize on the growing syndromic testing market.
The Remote Results Application feature in the QIAstat-Dx Analyzer 2.0 marks a significant technological advancement in syndromic testing. This cloud-based connectivity enables real-time result access and collaboration, addressing a critical need in modern healthcare delivery. The system's ability to provide Ct values and amplification curves directly on the touchscreen, without additional software, streamlines laboratory workflows and enhances diagnostic efficiency.
The planned QIAstat-Dx Rise version, with its 160 tests per day capacity, represents a substantial throughput improvement that could attract larger healthcare facilities and drive higher consumable sales. The combination of increased testing capacity, remote accessibility and comprehensive data analytics positions QIAGEN competitively in the rapidly evolving diagnostic technology landscape.
QIAstat-Dx Respiratory Panel Mini targets the five most actionable respiratory pathogens in outpatient settings to help clinicians make precise treatment decisions // With the new test and the 21-target QIAstat-Dx Respiratory Panel Plus, clinicians can fine-tune their diagnostic approach for individual patients, promoting better diagnostic stewardship // FDA decision marks third positive U.S. regulatory outcome for QIAstat-Dx to date in 2024
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 and covers five common viral causes of illness: influenza A, influenza B, human rhinovirus, respiratory syncytial virus (RSV) and SARS-CoV-2. The panel leverages QIAstat-Dx’s ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, and are instantly viewable on the instrument touchscreen with no additional software required.
The QIAstat-Dx Respiratory Panel Mini is the second QIAstat-Dx respiratory panel to receive FDA clearance this year. While the comprehensive 21-target QIAstat-Dx Respiratory Panel Plus is highly suitable for hospitalized patients with risk factors for severe disease, the more targeted QIAstat-Dx Respiratory Panel Mini offers a streamlined approach for diagnosing the five most actionable pathogens causing upper respiratory infections. This makes it an invaluable tool in outpatient settings, where its efficiency can benefit the widest possible patient population. The two FDA-cleared tests together effectively tackle the unique challenges that clinicians encounter when diagnosing respiratory infections in both outpatient and inpatient settings.
“The QIAstat-Dx Respiratory Panel Mini and QIAstat-Dx Respiratory Panel Plus will improve diagnostic stewardship by enabling clinicians to tailor testing to each patient's unique needs, choosing between a full, comprehensive panel or a more targeted one,” said Nadia Aelbrecht, Vice President and Head of the Syndromic Testing Franchise at QIAGEN. “By streamlining the diagnostic process and delivering accurate results in about an hour for both outpatient and inpatient groups, these tests will enhance patient care, promote responsible antimicrobial stewardship and alleviate the strain on healthcare systems.”
Respiratory tract infections are the leading cause of emergency department visits and hospitalizations. The CDC estimates that up to 41 million cases of influenza occur each year in the U.S., leading to several hundred thousand hospitalizations and up to 51,000 deaths.[1]
Syndromic tests like QIAstat-Dx have been shown to improve the detection of infections, including those involving multiple pathogens, reducing the need for additional testing. By providing fast results, syndromic testing enables healthcare providers to make informed treatment decisions and discontinue empiric antibiotic treatment when viral pathogens are detected, reducing overall antibiotic usage and supporting the goal of responsible antimicrobial stewardship.
QIAGEN is expanding its portfolio for QIAstat-Dx in North America, with the recent launch of the QIAstat-Dx Analyzer 2.0, FDA clearance of the Gastrointestinal Panel 2 and submission for FDA clearance of the Meningitis/Encephalitis Panel. Submission for FDA clearance of the Gastrointestinal Panel Mini is planned before the end of this year.
After its launch in Europe in spring 2024, the QIAstat-Dx Analyzer 2.0 is now also available in the U.S. for use with the QIAstat-Dx Respiratory Panel Plus and the QIAstat-Dx Gastrointestinal Panel 2. An extension for use with the QIAstat-Dx Respiratory Panel Mini is already planned. The upgraded diagnostic system introduces the Remote Results Application, a unique feature in the syndromic testing space. It allows users to view, comment on, and confirm diagnostic test results directly from their desktop and mobile devices in any location, facilitating seamless collaboration across the healthcare system.
The QIAstat-Dx Rise higher‑capacity version provides comprehensive testing for up to 160 tests per day using eight Analytical Modules instead of four. It is available with CE-IVD marking in Europe as well as other countries that accept this marking and is planned for submission to the FDA in 2025. [2] QIAstat-Dx syndromic testing with cloud-based connectivity and epidemiological insights is available in more than 100 countries, with more than 4,000 instruments placed worldwide.
More information on the QIAstat-Dx portfolio can be found here: https://www.qiagen.com/product-categories/diagnostics-and-clinical-research/infectious-disease/qiastat-dx-syndromic-testing
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, 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” 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.cdc.gov/flu/about/burden/index.html, as of June 28, 2024
[2] Product availability may differ from country to country based on regulations and approvals.
FAQ
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