#United States #Chicago #DLBCL #Foresight Diagnostics #CLARITY MRD

Foresight Diagnostics Showcases Promising Results for MRD Assay

Foresight Diagnostics, Inc., a prominent player in the diagnostics field, unveiled significant findings from its CLARITY Minimal Residual Disease (MRD) assay during a prelude to the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for late May. The study, marking a milestone in DLBCL (Diffuse Large B-Cell Lymphoma) management, emphasizes the assay's role in enhancing treatment outcomes.

Study Overview

The large-scale observational study was led by Amsterdam UMC in collaboration with HOVON and IKNL, representing an extensive effort across more than 50 clinical sites in the Netherlands and Belgium. Over 150 patients with newly diagnosed DLBCL receiving curative-intent therapy participated in this prospective study, affirming the practical application of the Foresight CLARITY MRD assay.

Key Findings

Among the key outcomes presented:
1. ctDNA Detection at End of Treatment: At the end of treatment, 24% of patients exhibited ctDNA-MRD. Notably, 76% of patients were MRD-negative, indicating favorable responses to therapy.
2. Survival Analysis: Patients who tested MRD-positive demonstrated notably reduced progression-free survival (28% compared to 88% for their MRD-negative counterparts) and overall survival rates (50% vs. 97%). This stark contrast underscores the assay's prognostic significance.
3. Long-term Outcomes: In MRD-negative patients with complete response verified by PET, the study reported impressive 2-year progression-free survival (PFS) at 91% and overall survival (OS) at a remarkable 99%.
4. Relapse Patterns: A critical observation noted that all subjects who failed to achieve complete response via PET yet remained MRD-positive experienced subsequent relapse, pointing to the assay's efficacy in forecasting clinical outcomes.

Dr. David Kurtz, the Chief Medical Officer of Foresight Diagnostics, remarked, "These results provide crucial prospective validation of CLARITY's performance in a real-world patient cohort. We anticipate integrating our assay into standard clinical practices, enhancing treatment personalization for DLBCL patients."

Implications for DLBCL Management

Lead authors of the study, Dr. Steven Wang and Dr. Martine Chamuleau from Amsterdam UMC, emphasized that ultra-sensitive ctDNA-MRD detection surpasses traditional imaging methods, offering deeper insights that can aid in post-treatment management and risk stratification for DLBCL patients. Their findings advocate for a paradigm shift in the assessment of treatment responses, potentially guiding improved outcomes.

In addition to the study's findings, Foresight's technology featured prominently in other presentations during the congress, underscoring its substantial impact on the field of hematologic malignancies.

Presentation Details

• - Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial
• - Presenter: Dr. Steven Wang, MD, PhD (Amsterdam UMC)
• - Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
• - Date & Time: Friday, May 30, 2025, from 2:45 PM to 5:45 PM CT
• - Location: Room S100a or via livestream for remote attendees
• - Abstract Number: 7000

The anticipated presence at ASCO gives Foresight Diagnostics a platform to reinforce their innovation in cancer diagnostics, which aligns with their mission to provide solutions that facilitate personalized patient care in oncology. The ongoing advancement of the CLARITY MRD assay underlines the potential for enhanced therapeutic strategies in addressing complex conditions like DLBCL, further establishing Foresight's commitment to fighting cancer at a molecular level.

As Foresight Diagnostics progresses toward broader clinical integration, the healthcare community watches closely, hopeful for innovative pathways to improve patient outcomes in the fight against DLBCL and other malignancies.