QIAGEN has announced two strategic partnerships aimed at expanding its minimal residual disease (MRD) testing capabilities in oncology, collaborating with Foresight Diagnostics and Tracer Biotechnologies to advance companion diagnostic development across both solid tumors and hematological cancers.
Partnership with Foresight Diagnostics
The collaboration with Foresight Diagnostics focuses on developing a kit-based version of the company's CLARITY assay, a circulating tumor DNA (ctDNA)-based next-generation sequencing test for certain types of lymphoma. This partnership aims to transition the assay from its current format as a CLIA central laboratory service to an in-lab diagnostic kit, enabling broader clinical access and supporting pharmaceutical-sponsored trials with companion diagnostic applications.
"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 diagnostic kit that has the potential to enable personalized treatment strategies for lymphoma patients worldwide."
The CLARITY assay is designed to measure minimal residual disease with reported detection limits in parts per million, providing ultra-sensitive MRD detection capabilities. Once validated and approved in pharmaceutical-sponsored trials, this would represent the only ctDNA-based MRD assay available as both a central laboratory service and diagnostic kit capable of supporting clinical decision-making for patients with hematological cancers.
Collaboration with Tracer Biotechnologies
QIAGEN's partnership with Tracer Biotechnologies centers on creating companion diagnostics for MRD testing in solid tumors. These assays are designed for use on QIAGEN's QIAcuity digital PCR platform and utilize minimally invasive blood samples to monitor residual disease with high sensitivity. The approach offers a cost-efficient and rapid alternative to next-generation sequencing technologies while maintaining comparable results.
"Partnering with QIAGEN enables Tracer to bring our solid tumor MRD expertise to a broader market using a robust digital PCR platform in QIAcuity," said Mark Kaganovich, CEO of Tracer Biotechnologies. "With QIAcuity's sensitivity and scalability, we can deliver high-quality companion diagnostics that integrate seamlessly into clinical workflows and offer new options to oncologists and patients."
Strategic Significance for MRD Testing
Minimal residual disease testing is emerging as a cornerstone of oncology by enabling early detection of cancer recurrence and guiding timely therapy adjustments from blood samples. The technology offers a highly sensitive method to monitor treatment response, identify patients at risk of relapse before symptoms appear, and inform decisions on therapy usage. MRD testing is also gaining recognition as a surrogate endpoint in clinical trials, potentially accelerating drug development and regulatory review processes.
"These new partnerships represent 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. "We want to in particular strengthen our scalable, cost-effective solutions based on our QIAcuity digital PCR system and enable laboratories and healthcare providers worldwide to use MRD insights for guiding personalized treatment decisions for cancer patients."
QIAGEN's Comprehensive MRD Portfolio
QIAGEN's MRD portfolio encompasses sample technologies and testing platforms that support complete workflows from sample collection to clinical insights. The portfolio includes the QIAsymphony system for automated sample preparation, with the upgraded QIAsymphony Connect version scheduled for launch in late 2025. Additional components include PAXgene blood collection tubes for stabilized blood draws, extensive kit ranges for the QIAcuity family of digital PCR instruments, and QIAseq targeted gene panels for third-party NGS systems.
The company also offers QIAGEN Digital Insights solutions that provide integrated bioinformatics for comprehensive NGS data analysis and interpretation, enabling complete MRD results. These partnerships support the growing demand for decentralized, non-invasive tools that advance precision medicine and help deliver more personalized cancer care to patients worldwide.
