Summary:
Foresight Diagnostics announced the independent validation of its CLARITY MRD assay, showing strong prognostic performance in newly diagnosed DLBCL patients, with results to be presented at ASCO 2025.

Takeaways:

  1. The study is the largest independent validation of the CLARITY MRD assay to date.
  2. Over 150 DLBCL patients across 50 sites in the Netherlands and Belgium were included.
  3. The study was led by Amsterdam UMC in collaboration with HOVON and IKNL.

Foresight Diagnostics, Inc., a diagnostics company specializing in the development of ultra-sensitive minimal residual disease (MRD) detection, today announced the presentation of independent validation data demonstrating the prognostic performance of its Foresight CLARITY MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The results will be shared in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 31 to June 3, 2025, in Chicago, Illinois.

The prospective, multi-center observational study, led by Amsterdam UMC in close collaboration with the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON) and Netherlands Comprehensive Cancer Organization (IKNL), is the largest independent validation study of Foresight CLARITY to date, spanning more than 150 patients with frontline DLBCL treated uniformly with curative-intent therapy across 50 sites in the Netherlands and Belgium. 

Key Findings:

  • ctDNA-MRD was detected at end of treatment (EOT) in 24% of patients; 76% were MRD-negative.
  • MRD-positive patients showed significantly lower progression-free survival (28% vs. 88%) and overall survival (50% vs. 97%) compared to MRD-negative patients. 
  • Among patients who were MRD-negative and achieved PET complete response at EOT, 2-year progression-free survival (PFS) and overall survival (OS) were 91% and 99%, respectively. 
  • All patients who failed to achieve complete response by PET and remained MRD-positive experienced relapse.
  • ctDNA-MRD remained a powerful independent predictor of outcomes across multiple clinical subgroups, even after adjusting for standard prognostic factors.

“These results provide important prospective validation of Foresight CLARITY’s clinical performance in frontline DLBCL across a large, real-world patient cohort,” says David Kurtz, MD, chief medical officer of Foresight Diagnostics. “This study adds to a growing body of clinical evidence that we believe should strengthen the field’s confidence in our assay’s ability to accurately assess treatment response. We remain on track for a planned launch into the clinical market and look forward to integrating CLARITY into routine clinical practice.”

Lead study authors Steven Wang, MD, and Martine Chamuleau, MD, PhD, Amsterdam UMC, added: “Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL.”

Featured Image: Dzmitry Auramchik | Dreamstime.com