BOULDER, Colo., May 29, 2024 – Foresight Diagnostics, a leader in ultra-sensitive liquid biopsy-based minimal residual disease (MRD) detection, today announced its upcoming poster presentation at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting. In partnership with Memorial Sloan Kettering Cancer Center and Stanford University, this study showcases the improved sensitivity and superior clinical performance of MRD detection by Foresight CLARITY™ in early-stage non-small cell lung cancer (NSCLC) within the post-operative adjuvant setting as compared to MRD detection by conventional liquid biopsy-based methods.
Foresight CLARITY MRD detection platform is powered by PhasED-Seq™, a technology that utilizes a patient’s unique set of phased variants to identify circulating tumor DNA (ctDNA) as a measure of residual disease. Research shows that over 50% of NSCLC patients harbor ctDNA levels below 1 part per ten thousand (1×10-4), which is the typical limit of detection of conventional MRD assays. By leveraging its proprietary phased variant technology, Foresight CLARITY delivers an analytical sensitivity of less than 1 part per million (<1×10-6).
One of the most challenging questions in oncology is determining which patients still have residual cancer in their bodies after their primary tumor has been removed and which are truly disease free. Using ctDNA MRD to identify patients who might benefit from further treatment after surgery (termed ‘adjuvant treatment’) is a promising but challenging approach due to the low levels of ctDNA MRD at this timepoint. In their poster presentation “Ultrasensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) detection in early-stage non-small cell lung cancer (NSCLC),” Foresight and its partners evaluated the ability of Foresight CLARITY to identify patients who are MRD positive post-surgery and predict survival benefit from adjuvant therapy.
Key findings include:
>2x improved detection: In pre-treatment samples, Foresight CLARITY accurately detected ctDNA MRD in 62% (13 of 21 cases) of early-stage (I and II) lung adenocarcinomas compared to a detection rate of only 29% (6 of 21 cases) by conventional SNV-based methods.
>2x improved clinical sensitivity: Foresight CLARITY detected MRD at the post-therapy landmark in 67% of patients (12 out of 18 cases) who relapsed compared to conventional SNV-based methods only detecting MRD in 28% (5 out of 18 cases).
Superior clinical performance in an adjuvant setting: Retrospective analysis of this cohort using Foresight CLARITY showed that post-operative ctDNA MRD positive patients that received adjuvant therapy demonstrated significantly improved outcomes and achieved MRD clearance compared to ctDNA MRD positive patients that did not receive therapy (see figures below). Among post-operative ctDNA MRD negative patients, no significant difference in outcomes was observed between those who did and did not receive adjuvant therapy.
“Based on these results, we now have another new tool that can help clinicians determine the need for post-operative treatment,” said Dr. James Isbell, thoracic surgeon at Memorial Sloan Kettering Cancer Center and lead poster author.
“We are optimistic that these results will encourage the utilization of ctDNA MRD detection in drug development and clinical trials for lung cancer, which to date has been hampered by the performance level of many existing assays,” said Dr. David Kurtz, Chief Medical Officer and Head of Research at Foresight Diagnostics. “We look forward to continuing and expanding our partnerships with academia and pharmaceutical companies to allow us to continue building evidence around ctDNA MRD utilization in both the adjuvant and neoadjuvant settings.”
For more information, please attend our poster session (details below), visit booth IH#16, or request a meeting with our team.
Ultrasensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) detection in early-stage non-small cell lung cancer (NSCLC)
- Presenting Author: James Isbell, MD, MSCI
- Date: June 3, 2024
- Poster Session: 1:30pm-4:30pm CT
Citation
1. Isbell, et al. AACR 2023
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 a significantly higher level of sensitivity than most other liquid biopsy tests, delivering a detection limit below 0.0001%, or one part-per-million. The improved sensitivity of Foresight CLARITY can 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.
About PhasED-Seq
The Foresight CLARITY MRD Detection platform is based on the Phased Variant Enrichment and Detection by Sequencing (PhasED-Seq™) technology. PhasED-Seq lowers the error profile of mutation detection in sequencing data by requiring the concordant detection of two separate non-reference events in an individual DNA molecule. By detecting more than one mutation, PhasED-Seq can more accurately distinguish tumor-derived cell free DNA (i.e., ctDNA) from healthy cell free DNA – enabling detection of ctDNA at levels below one part-per-million (<0.0001%). PhasED-Seq has been extensively tested in thousands of patient samples.
