High-risk prostate cancer has a high relapse and mortality rate, highlighting the need for more effective therapies. The ADAPPT protocol trial addresses this by enabling neoadjuvant treatment strategies to eradicate detectable disease in patients for whom single treatments are insufficient. Through a multiomic approach to MRD detection we aim to establish a six-month regulatory efficacy endpoint, which will help predict treatment resistance and expedite drug development to improve patient outcomes.

Justin Odegaard, Vice President of Clinical Development at Guardant Health, will explore how liquid biopsy technology combined with AI is transforming precision oncology. The session will cover the latest breakthroughs in detecting minimal residual disease and applying genomic insights to optimize cancer treatment decisions, ultimately advancing patient outcomes in clinical care.

As technology continues to advance towards new non-invasive cancer screening modalities, particularly blood-based testing, the U.S. health care system lags in its ability to ensure a pathway to coverage and access for patients. This talk will summarize the U.S. policy environment related to cancer screening coverage, identify gaps, and consider potential solutions to accommodate emerging blood-based cancer screening tests.

This presentation will cover: 1) how the integration of ctDNA as a molecular response biomarker in early clinical trials improves patient risk stratification; 2) investigating case studies that demonstrate how molecular response assessment using ctDNA can predict clinical outcomes; 3) harnessing ctDNA data alongside radiographic imaging for informed early Go/No-Go decisions in clinical trials.

Working to align the liquid biopsy community through collaboration. The BLOODPAC MRD AV working group has recently published the Tumor-informed MRD Generic Analytical Validation Protocols. As the field continues to expand, the group will work to develop tumor agnostic MRD AV protocols. The session will discuss how we got here, how we move forward, and how these decisions will impact the patient journey as well as work to reduce costs associated with treatment of disease recurrence.

DELFI- tumor fraction (DELFI-TF) is a tumor agnostic, mutation independent whole genome sequencing test to determine the genome wide circulating tumor (ctDNA) burden. DELFI-TF scores are independent predictors of overall survival (HR = 9.84, 95% CI = 1.72-56.10, p < 0.0001). This presentation will discuss the potential to use cfDNA fragmentomes to estimate tumor burden in cfDNA for treatment response monitoring and clinical outcome prediction.