Foresight Diagnostics (Foresight) today announced new data from its ultra-sensitive Foresight CLARITY™ minimal residual disease (MRD) platform in early-stage breast cancer that will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) this month.

Foresight and Memorial Sloan Kettering (MSK) will present an analysis of 470 samples from 81 early-stage breast cancer patients demonstrating that ctDNA clearance following various perioperative treatments – including surgery, neoadjuvant chemotherapy, and adjuvant chemotherapy – is strongly associated with favorable survival outcomes.

Key findings from the research include:

• 34% of pre-treatment and 68% of post-treatment samples with detectable ctDNA had ctDNA levels <10^-4 (<0.01%), the approximate sensitivity limit for 1st generation ctDNA-MRD assays. All samples obtained post-neoadjuvant treatment with detectable ctDNA had tumor fractions <10^-4.
• Upfront surgery cleared ctDNA in the majority of patients with detectable baseline ctDNA. This highlights the origin of ctDNA detection as either from primary or micrometastatic disease.
• Post-surgical ctDNA-MRD positivity was associated with recurrence, and subsequent clearance of ctDNA-MRD by adjuvant therapy further predicted long-term recurrence-free survival.
• All patients with disease progression who had end of treatment blood samples available had detectable ctDNA (n=9/9; 100% sensitivity).

"This analysis builds upon research presented earlier this year at the European Society for Medical Oncology (ESMO) Congress. The consistency of Foresight CLARITY's performance in early-stage breast cancer provides us as a field with the confidence to explore novel applications of minimal residual disease detection in advancing precision medicine research," said David Kurtz, MD, PhD, Foresight's Chief Medical Officer and Head of Research. “We are particularly excited about the potential to investigate how molecular response monitoring might inform both treatment escalation and de-escalation strategies in future studies."

"These findings expand our understanding of how different breast cancer treatments affect molecular residual disease," said Pedram Ravazi, MD, PhD, breast medical oncologist and Director of Liquid Biopsy & Genomics at MSK. "By utilizing ultra-sensitive MRD detection at multiple timepoints throughout the patient treatment journey, we were able to differentiate responses to both local and systemic therapies. This level of insight opens new avenues for research into whether prospective, risk-based treatment decisions could potentially improve cure rates in the first-line setting in early-stage breast cancer."

The research is part of MSK's Liquid Biopsy for INterception of Cancer (MSK-LINC) study, a prospective investigation assessing MRD detection during and after curative-intent therapy. The study spans diverse breast cancer subtypes, including hormone receptor-positive, HER2-positive, and triple-negative breast cancer.

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

For more information contact BD@foresight-dx.com or visit www.foresight-dx.com.

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 measures minimal residual disease (MRD) with reported detection limits in parts per million1. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

1 Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

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