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QIAGEN expands QIAstat-Dx into precision medicine through partnership for companion diagnostics in chronic diseases

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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.

QIAGEN ha espanso la sua partnership con AstraZeneca per sviluppare e commercializzare diagnosi companion (CDx) per malattie croniche utilizzando la piattaforma QIAstat-Dx. Questo accordo estende la loro collaborazione oltre l'oncologia, consentendo decisioni rapide sulla idoneità dei pazienti per i medicinali mirati genomicamente di AstraZeneca. QIAGEN svilupperà un saggio di genotipizzazione per il sistema QIAstat-Dx, che può fornire risultati in circa un'ora utilizzando la tecnologia PCR in tempo reale multipla.

La piattaforma QIAstat-Dx, con oltre 4.000 installazioni cumulative di strumenti entro la fine del 2023, offre cartucce monouso a costi contenuti e fornisce ulteriori informazioni attraverso i valori di soglia di ciclo e le curve di amplificazione. Questa espansione mette in evidenza l'expertise di QIAGEN nello sviluppo di CDx e la sua capacità di adattare i prodotti alle esigenze dei partner attraverso varie tecnologie, inclusa la PCR, la PCR digitale e il sequenziamento di nuova generazione.

QIAGEN ha ampliado su asociación con AstraZeneca para desarrollar y comercializar diagnósticos de acompañamiento (CDx) para enfermedades crónicas utilizando la plataforma QIAstat-Dx. Este acuerdo extiende su colaboración más allá de la oncología, permitiendo toma de decisiones rápidas sobre la idoneidad del paciente para los medicamentos dirigidos genéticamente de AstraZeneca. QIAGEN desarrollará un ensayo de genotipificación para el sistema QIAstat-Dx, que puede proporcionar resultados en aproximadamente una hora utilizando la tecnología de PCR en tiempo real multiplex.

La plataforma QIAstat-Dx, con más de 4,000 colocaciones de instrumentos acumulativas para finales de 2023, ofrece cartuchos de un solo uso y a bajo costo, y proporciona información adicional a través de los valores de umbral del ciclo y las curvas de amplificación. Esta expansión destaca la experiencia de QIAGEN en el desarrollo de CDx y su capacidad para adaptar productos a las necesidades de los socios a través de diversas tecnologías, incluida la PCR, PCR digital y secuenciación de próxima generación.

QIAGEN은 AstraZeneca와의 파트너십을 확대하여 만성 질환에 대한 동반 진단(CDx)을 개발하고 상용화하기 위해 QIAstat-Dx 플랫폼을 사용합니다. 이번 계약은 그들의 협력을 종양학을 넘어 확장하여, AstraZeneca의 유전자 표적 약물에 대한 환자 적합성에 대한 신속한 의사결정을 가능하게 합니다. QIAGEN은 QIAstat-Dx 시스템을 위한 유전자형 분석을 개발하여, 다중 실시간 PCR 기술을 이용해 약 한 시간 이내에 결과를 제공할 수 있습니다.

2023년 말까지 4,000건 이상의 누적 기기 설치를 기록한 QIAstat-Dx 플랫폼은 비용 효율적이고 일회용 카트리지를 제공하며, 주기 한계 값 및 증폭 곡선을 통해 추가 통찰력을 제공합니다. 이번 확장은 QIAGEN의 CDx 개발 전문성과 PCR, 디지털 PCR 및 차세대 시퀀싱 등의 다양한 기술에 따라 파트너의 요구에 제품을 맞출 수 있는 능력을 보여줍니다.

QIAGEN a élargi son partenariat avec AstraZeneca pour développer et commercialiser des diagnostics compagnons (CDx) pour des maladies chroniques en utilisant la plateforme QIAstat-Dx. Cet accord prolonge leur collaboration au-delà de l'oncologie, permettant ainsi une prise de décision rapide concernant l'adéquation des patients aux médicaments ciblés génomiquement d'AstraZeneca. QIAGEN développera un essai de génotypage pour le système QIAstat-Dx, qui peut fournir des résultats en environ une heure en utilisant la technologie PCR multiplex en temps réel.

La plateforme QIAstat-Dx, avec plus de 4 000 installations d'instruments cumulées d'ici la fin de 2023, offre des cartouches à usage unique et à coût réduit, et fournit des informations supplémentaires grâce aux valeurs de seuil de cycle et aux courbes d'amplification. Cette expansion met en avant l'expertise de QIAGEN dans le développement de CDx et sa capacité à adapter les produits aux besoins des partenaires à travers diverses technologies, y compris la PCR, la PCR digitale et le séquençage de nouvelle génération.

QIAGEN hat die Partnerschaft mit AstraZeneca erweitert, um Begleitdiagnosen (CDx) für chronische Erkrankungen unter Verwendung der QIAstat-Dx Plattform zu entwickeln und zu vermarkten. Diese Vereinbarung erweitert die Zusammenarbeit über die Onkologie hinaus und ermöglicht schnelle Entscheidungsfindung über die Eignung von Patienten für die genomisch gezielten Medikamente von AstraZeneca. QIAGEN wird einen Genotypisierungsassay für das QIAstat-Dx-System entwickeln, der Ergebnisse in etwa einer Stunde unter Verwendung der Multiplex-echtzeit PCR-Technologie liefern kann.

Die QIAstat-Dx-Plattform, mit über 4.000 kumulierten Geräteplatzierungen bis Ende 2023, bietet kosteneffiziente Einwegkartuschen und zusätzliche Einblicke durch Zyklus-Schwellenwerte und Amplifikationskurven. Diese Erweiterung zeigt die Expertise von QIAGEN in der Entwicklung von CDx und die Fähigkeit, Produkte an die Bedürfnisse von Partnern über verschiedene Technologien hinweg anzupassen, einschließlich PCR, digitaler PCR und Next-Generation-Sequencing.

Positive
  • Expansion of partnership with AstraZeneca into chronic diseases, potentially increasing market reach
  • Development of first companion diagnostic for chronic diseases on QIAstat-Dx platform
  • QIAstat-Dx system has over 4,000 cumulative instrument placements as of end 2023
  • QIAGEN has master collaboration agreements with more than 30 global companies for CDx development
Negative
  • None.

Insights

The expansion of QIAGEN's partnership with AstraZeneca into chronic diseases marks a significant shift in companion diagnostics. The QIAstat-Dx genotyping assay could revolutionize patient care by enabling rapid, point-of-care genetic testing during routine clinical examinations. This approach could dramatically reduce time-to-treatment for patients with genomically targetable conditions, potentially improving outcomes. However, the success of this initiative will depend on the accuracy and reliability of the QIAstat-Dx platform in real-world clinical settings. The move also signals a growing trend towards personalized medicine in chronic disease management, which could reshape treatment paradigms across multiple specialties.

QIAGEN's expansion into chronic disease companion diagnostics presents a significant market opportunity. With over 4,000 QIAstat-Dx instruments already placed, the company has a solid foundation for rapid commercialization. The chronic disease market is substantially larger than oncology, potentially leading to increased recurring revenue from test cartridges. However, investors should note that the development and regulatory approval process for new CDx tests can be lengthy and costly. The partnership with AstraZeneca mitigates some risk, but success will ultimately depend on the clinical utility and adoption of the genotyping assay. QIAGEN's diverse technology portfolio and extensive CDx partnerships (over 30 global companies) provide a competitive edge in this expanding market.

This partnership expansion signifies a strategic pivot in the diagnostics industry. The move from oncology to chronic diseases opens up a vast new market, as chronic conditions affect a larger patient population. The QIAstat-Dx platform's ability to provide results in about an hour could be a game-changer for clinical workflows, potentially increasing demand for QIAGEN's products. However, market adoption may face challenges such as healthcare provider education and reimbursement hurdles. The success of this initiative could spark a trend of similar partnerships in the industry, potentially reshaping the competitive landscape. Investors should monitor the rate of adoption and any regulatory developments that could impact the rollout of these new companion diagnostics.

New agreement expands collaboration with AstraZeneca beyond oncology, including complex chronic diseases // QIAGEN’s syndromic testing platform QIAstat-Dx enables specialty care providers to make fast decisions about patients’ eligibility for investigational precision medicines

Venlo, the Netherlands, Aug. 28, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its Master Collaboration Agreement with AstraZeneca to develop and commercialize companion diagnostics (CDx) for AstraZeneca’s future therapies being developed to address chronic diseases.

Under the agreement, QIAGEN will develop and validate a genotyping assay using QIAGEN’s syndromic testing platform QIAstat-Dx. The test will enable specialty care providers to potentially perform genotyping whilst patients are undergoing routine clinical examination, thus enabling fast decision making for potential suitability for AstraZeneca’s genomically targeted medicines.

“We are pleased to expand our partnership with AstraZeneca into new disease areas using our QIAstat‑Dx system and to develop together the first companion diagnostic for chronic diseases based on this platform”, said Fernando Beils, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “The development of the QIAstat-Dx genotyping assay with AstraZeneca showcases QIAGEN’s expertise in companion diagnostic development and commercialization, utilizing the most suitable molecular testing platform to meet the unique clinical and commercial needs of patient testing.”

The QIAstat-Dx system, designed for laboratory use, employs cost-efficient, single-use cartridges with built-in sample processing and on-board reagents. Utilizing multiplex real-time PCR, it detects and differentiates between multiple biomarkers, with results in about an hour. QIAstat-Dx also provides easy‑to‑view cycle threshold (Ct) values and amplification curves, offering additional insights not available with end-point PCR or other techniques. At the end of 2023, over 4,000 cumulative instrument placements had been made.

QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics. These can detect genetic abnormalities to provide insights that guide clinical decision-making about treatments. From polymerase chain reaction (PCR) and digital PCR (dPCR) to next-generation sequencing (NGS), QIAGEN offers an unmatched breadth of technologies, which means it can tailor products to partners’ needs.

QIAGEN has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global companies – a deep pipeline that will advance precision medicine, which tailors a patient’s treatment to the genetic profile identified by companion diagnostics testing. Furthermore, QIAGEN has a series of collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.

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 approximately 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


FAQ

What is the new partnership between QIAGEN and AstraZeneca for QGEN stock?

QIAGEN (QGEN) has expanded its partnership with AstraZeneca to develop and commercialize companion diagnostics for chronic diseases using the QIAstat-Dx platform, extending their collaboration beyond oncology.

How will the QIAstat-Dx genotyping assay benefit patients according to QGEN's announcement?

The QIAstat-Dx genotyping assay will enable specialty care providers to potentially perform genotyping during routine clinical examinations, allowing for fast decision-making regarding patient suitability for AstraZeneca's genomically targeted medicines.

What are the key features of QIAGEN's QIAstat-Dx system mentioned in the press release?

The QIAstat-Dx system uses cost-efficient, single-use cartridges with built-in sample processing, employs multiplex real-time PCR, detects multiple biomarkers, provides results in about an hour, and offers additional insights through cycle threshold values and amplification curves.

How many QIAstat-Dx instruments had QIAGEN (QGEN) placed by the end of 2023?

According to the press release, QIAGEN had made over 4,000 cumulative instrument placements of the QIAstat-Dx system by the end of 2023.

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