Foresight Diagnostics (Foresight) today revealed new data from its ultra-sensitive Foresight CLARITY™ minimal residual disease (MRD) platform in early-stage breast cancer, which will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) later this month.
Foresight Diagnostics and Memorial Sloan Kettering (MSK) will present new analysis at the 2024 San Antonio Breast Cancer Symposium (SABCS) on 470 samples from 81 early-stage breast cancer patients. The study shows that ctDNA clearance after various perioperative treatments—including surgery, neoadjuvant chemotherapy, and adjuvant chemotherapy—is strongly linked to favorable survival outcomes.
Key findings include:
- 34% of pre-treatment and 68% of post-treatment samples with detectable ctDNA had ctDNA levels below <10-4 (<0.01%), the sensitivity limit for first-generation ctDNA-MRD assays. All post-neoadjuvant treatment samples with detectable ctDNA had tumor fractions below <10-4.
- Surgery cleared ctDNA in most patients with detectable baseline ctDNA, highlighting the origin of ctDNA as from either primary or micrometastatic disease.
- Post-surgical ctDNA-MRD positivity was associated with recurrence, and subsequent ctDNA-MRD clearance following adjuvant therapy predicted long-term recurrence-free survival.
- All patients with disease progression who had end-of-treatment blood samples available showed detectable ctDNA (9/9 patients, 100% sensitivity).
David Kurtz, MD, PhD, Foresight’s Chief Medical Officer and Head of Research, commented, “This analysis builds on earlier research presented at the European Society for Medical Oncology (ESMO) Congress. The consistency of Foresight CLARITY’s performance in early-stage breast cancer strengthens our confidence in using MRD detection to advance precision medicine.”
Pedram Ravazi, MD, PhD, breast oncologist at MSK, added, “These findings provide deeper insights into how different treatments affect molecular residual disease. By using ultra-sensitive MRD detection at multiple timepoints, we can differentiate responses to local and systemic therapies. This opens new possibilities for prospective, risk-based treatment decisions that could improve cure rates in early-stage breast cancer.”
This research is part of MSK’s Liquid Biopsy for INterception of Cancer (MSK-LINC) study, which investigates MRD detection during and after curative-intent therapy across various breast cancer subtypes.
The full data will be presented at SABCS 2024:
P2-01-25: “Circulating tumor DNA clearance by neoadjuvant chemotherapy or breast surgery detected using an ultrasensitive ctDNA MRD assay in early breast cancer.” Presented by Luc Cabel, MD, PhD (Visiting Investigator, MSK) Poster Session 2: Wednesday, December 11, 2024, 5:30-7:00pm
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 detects minimal residual disease (MRD) with sensitivity in parts per million. Foresight CLARITY has the potential to provide actionable insights to physicians and biopharmaceutical companies for more personalized treatment strategies in solid tumor and hematologic malignancies.