Summary:
Foresight Diagnostics and QIAGEN have entered a global partnership to develop and commercialize a kit-based version of Foresight’s CLARITY assay for ultra-sensitive minimal residual disease (MRD) detection in hematological cancers.

Takeaways:

  • The CLARITY assay will be transformed into a standardized, regulated diagnostic kit suitable for both IVD and CDx applications.
  • The collaboration merges Foresight’s ctDNA-based MRD technology with QIAGEN’s global reach and regulatory expertise.
  • Once validated, the kit could become the only ctDNA-based MRD assay available both as a centralized lab service and a diagnostic kit for lymphoma and related cancers.

Foresight Diagnostics, a diagnostics company specializing in ultra-sensitive minimal residual disease (MRD) detection, today announced a strategic, worldwide partnership with QIAGEN 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.

“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,” says 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 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, according to the companies. 

“This new partnership represents an important step in strengthening QIAGEN’s leadership in oncology by aiming to bring innovative MRD technologies into clinical practice,” says 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.”

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