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

Rhea-AI Summary

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.

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

Biotechnology Analyst

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.

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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.