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Foresight Diagnostics and QIAGEN Announce Strategic Partnership to Advance Development of Companion Diagnostic Kits for Lymphoma

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Foresight Diagnostics and QIAGEN (NYSE: QGEN) have announced a strategic worldwide partnership to develop and commercialize a kit version of Foresight's CLARITY™ assay for minimal residual disease (MRD) detection in lymphoma and other blood cancers. The collaboration combines Foresight's MRD detection technology with QIAGEN's global molecular diagnostic expertise. The partnership aims to create a standardized, regulated diagnostic kit that would be unique in offering both central laboratory service and diagnostic capabilities for ctDNA-based MRD testing. This kit, once validated and approved, will support clinical decision-making and therapeutic strategies for hematological cancer patients, enabling personalized treatment approaches through next-generation sequencing technology.
Foresight Diagnostics e QIAGEN (NYSE: QGEN) hanno annunciato una partnership strategica a livello mondiale per sviluppare e commercializzare una versione kit del test CLARITY™ di Foresight per la rilevazione della malattia minima residua (MRD) nel linfoma e in altri tumori del sangue. La collaborazione unisce la tecnologia di rilevazione MRD di Foresight con l'esperienza globale di QIAGEN nella diagnostica molecolare. L'obiettivo è creare un kit diagnostico standardizzato e regolamentato, unico nel suo genere, che offra sia il servizio di laboratorio centrale sia capacità diagnostiche per il test MRD basato su ctDNA. Una volta validato e approvato, questo kit supporterà le decisioni cliniche e le strategie terapeutiche per i pazienti con tumori ematologici, permettendo approcci di trattamento personalizzati grazie alla tecnologia di sequenziamento di nuova generazione.
Foresight Diagnostics y QIAGEN (NYSE: QGEN) han anunciado una alianza estratégica mundial para desarrollar y comercializar una versión en kit del ensayo CLARITY™ de Foresight para la detección de enfermedad mínima residual (MRD) en linfoma y otros cánceres de sangre. La colaboración combina la tecnología de detección MRD de Foresight con la experiencia global en diagnóstico molecular de QIAGEN. La asociación tiene como objetivo crear un kit diagnóstico estandarizado y regulado, único en ofrecer tanto servicio de laboratorio central como capacidades diagnósticas para pruebas MRD basadas en ctDNA. Este kit, una vez validado y aprobado, apoyará la toma de decisiones clínicas y las estrategias terapéuticas para pacientes con cáncer hematológico, facilitando enfoques de tratamiento personalizados mediante tecnología de secuenciación de próxima generación.
포사이트 다이애그노스틱스와 QIAGEN(NYSE: QGEN)은 림프종 및 기타 혈액암에서 최소 잔류 질환(MRD) 검출을 위한 포사이트의 CLARITY™ 분석법 키트 버전을 개발하고 상용화하기 위한 전략적 전 세계 파트너십을 발표했습니다. 이번 협력은 포사이트의 MRD 검출 기술과 QIAGEN의 글로벌 분자 진단 전문성을 결합합니다. 이 파트너십은 중앙 실험실 서비스와 ctDNA 기반 MRD 검사 진단 기능을 모두 제공하는 독특한 표준화되고 규제된 진단 키트를 만드는 것을 목표로 합니다. 이 키트는 검증 및 승인을 받으면 혈액암 환자의 임상 의사 결정과 치료 전략을 지원하며, 차세대 시퀀싱 기술을 통해 개인 맞춤형 치료 접근법을 가능하게 할 것입니다.
Foresight Diagnostics et QIAGEN (NYSE : QGEN) ont annoncé un partenariat stratégique mondial pour développer et commercialiser une version kit du test CLARITY™ de Foresight, destiné à la détection de la maladie résiduelle minimale (MRD) dans les lymphomes et autres cancers du sang. Cette collaboration associe la technologie de détection MRD de Foresight à l'expertise mondiale de QIAGEN en diagnostic moléculaire. Le partenariat vise à créer un kit diagnostique standardisé et réglementé, unique en son genre, offrant à la fois un service de laboratoire central et des capacités diagnostiques pour les tests MRD basés sur l'ADN circulant tumoral (ctDNA). Une fois validé et approuvé, ce kit soutiendra la prise de décision clinique et les stratégies thérapeutiques pour les patients atteints de cancers hématologiques, permettant des approches de traitement personnalisées grâce à la technologie de séquençage de nouvelle génération.
Foresight Diagnostics und QIAGEN (NYSE: QGEN) haben eine strategische weltweite Partnerschaft angekündigt, um eine Kit-Version des CLARITY™-Assays von Foresight zur Erkennung minimaler Resterkrankung (MRD) bei Lymphomen und anderen Blutkrebserkrankungen zu entwickeln und zu vermarkten. Die Zusammenarbeit kombiniert Foresights MRD-Erkennungstechnologie mit QIAGENs globaler Expertise in der molekularen Diagnostik. Ziel der Partnerschaft ist es, ein standardisiertes und reguliertes Diagnostik-Kit zu schaffen, das einzigartig ist, da es sowohl zentrale Laborleistungen als auch diagnostische Fähigkeiten für ctDNA-basierte MRD-Tests bietet. Dieses Kit wird, nach Validierung und Zulassung, die klinische Entscheidungsfindung und therapeutische Strategien für Patienten mit hämatologischen Krebserkrankungen unterstützen und personalisierte Behandlungsansätze durch Next-Generation-Sequenzierungstechnologie ermöglichen.
Positive
  • Partnership combines Foresight's innovative MRD detection technology with QIAGEN's global molecular diagnostic infrastructure
  • Development of the first ctDNA-based MRD assay available as both central laboratory service and diagnostic kit
  • Potential expansion of QIAGEN's oncology diagnostic portfolio
  • Scalable, cost-effective solution for laboratories and healthcare providers worldwide
Negative
  • None.

Insights

QIAGEN's partnership with Foresight enhances oncology diagnostics portfolio, targeting the growing MRD testing market with differentiated kit-based solution.

This strategic partnership positions QIAGEN to expand its precision oncology footprint in the rapidly growing minimal residual disease (MRD) testing market. The collaboration with Foresight Diagnostics aims to transform Foresight's CLARITY™ assay into a standardized diagnostic kit for hematological malignancies, particularly lymphoma.

What makes this partnership particularly significant is the dual-format approach. If successfully developed and approved, this would be the only circulating tumor DNA-based MRD assay available in both central lab and kit formats, giving QIAGEN a competitive advantage in the market. This versatility would allow hospitals to either perform testing in-house or send samples to reference laboratories, depending on their capabilities.

The MRD testing market represents a high-growth segment within oncology diagnostics, with increasing clinical utility for monitoring treatment response, detecting early relapse, and guiding therapy selection. By leveraging Foresight's highly sensitive ctDNA detection technology alongside QIAGEN's global commercial infrastructure and regulatory expertise, this partnership could potentially accelerate time-to-market for a regulated companion diagnostic solution.

For QIAGEN, this aligns perfectly with their strategy to strengthen their oncology portfolio through partnerships rather than just internal development. The addition of a kit-based MRD solution complements their existing molecular diagnostic platforms and expands their test menu in oncology applications. While revenue impact will depend on clinical validation, regulatory approvals, and pharmaceutical partnerships, this represents a logical strategic move to capture share in the growing precision oncology market.

BOULDER, Colo., Jun 2, 2025 /PRNewswire/ -- Foresight Diagnostics, a leading diagnostics company specializing in ultra-sensitive minimal residual disease (MRD) detection, today announced a strategic, worldwide partnership with QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) to develop and commercialize a kit-based version of Foresight's CLARITY™ assay, with the goal of enabling global in vitro diagnostic (IVD) and companion diagnostic (CDx) applications in lymphoma and other hematological malignancies.

This collaboration combines Foresight's innovative MRD detection technology with QIAGEN's global leadership in molecular diagnostic development and commercialization. Together, the companies aim to lay the groundwork for a standardized, regulated diagnostic kit that, once validated and approved in pharmaceutical-sponsored trials, would be the only circulating tumor DNA (ctDNA)-based MRD assay available as both a central laboratory service and diagnostic kit capable of supporting clinical decision-making and therapeutic strategies for patients with hematological cancers.

"We are excited to partner with QIAGEN to accelerate the development of a kit-based version of our CLARITY™ assay and expand our ability to support pharmaceutical companies in developing companion diagnostics and IVD solutions globally," said Jake Chabon, Chief Executive Officer of Foresight Diagnostics. "By combining our leading MRD technology with QIAGEN's global infrastructure and expertise, we are well-positioned to deliver a regulated diagnostic kit that has the potential to enable personalized treatment strategies for lymphoma patients worldwide."

 "This new partnership represents an important step in strengthening QIAGEN's leadership in oncology by aiming to bring innovative MRD technologies into clinical practice," said Jonathan Arnold, Vice President, Head of Precision Partnering Diagnostics at QIAGEN. "By offering scalable, cost-effective solutions through the use of next-generation sequencing technology, we want to enable more laboratories and healthcare providers around the world to use MRD insights for guiding personalized treatment decisions for cancer patients."

For more information about Foresight Diagnostics and the CLARITY™ assay, visit www.foresight-dx.com.

About Foresight Diagnostics

Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/foresight-diagnostics-and-qiagen-announce-strategic-partnership-to-advance-development-of-companion-diagnostic-kits-for-lymphoma-302470896.html

SOURCE Foresight Diagnostics, Inc.

FAQ

What is the purpose of the QIAGEN and Foresight Diagnostics partnership?

The partnership aims to develop and commercialize a kit version of Foresight's CLARITY™ assay for minimal residual disease detection in lymphoma and blood cancers, combining Foresight's MRD technology with QIAGEN's global diagnostic expertise.

What makes the QGEN-Foresight CLARITY™ assay unique in the market?

Once approved, it would be the only ctDNA-based MRD assay available as both a central laboratory service and diagnostic kit for supporting clinical decisions in hematological cancers.

How will the QIAGEN partnership benefit healthcare providers?

The partnership will provide scalable, cost-effective solutions through next-generation sequencing technology, enabling more laboratories and healthcare providers to use MRD insights for personalized cancer treatment decisions.

What types of cancer will the QGEN-Foresight diagnostic kit target?

The diagnostic kit will target lymphoma and other hematological malignancies (blood cancers).

What is the current status of the QGEN-Foresight CLARITY™ diagnostic kit?

The kit is in development and will need to undergo validation and approval in pharmaceutical-sponsored trials before becoming available for clinical use.
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