Single- or multi-cancer detection tests require high specificity when applied to the general population which in general reduces sensitivity and detecting cancer at an early stage. Identifying an individual’s cancer risk based on subject characteristics and their biomarker profile allows tailoring screening according to risk. Personalized risk assessment also provides an opportunity for preventive intervention.

Recently, liquid biopsies have been commercialized for early cancer detection, including both multi-cancer and single-cancer detection tests. This is a nascent market: pre-FDA approval, pre-guideline recommendations, and, for the most part, pre-reimbursement. The trajectory of the EDx testing clinical paradigm and market is likely to be shaped by the experiences of these early adopters. To better understand these experiences, we conducted a survey of clinicians who have ordered early cancer detection tests in routine care, probing on how they use them today, their satisfaction with the tests and diagnostic journey, and how they expect to use these tests going forward. We also gathered perspectives from non-adopters, to understand what it would take to drive adoption, and how they expect they will implement these tests into their practice. This presentation aims to shed light on the opportunities and challenges ahead for what has potential to be a disruptive clinical paradigm.

Mercy BioAnalytics is developing simple, low-cost blood tests for the early detection of cancer using a novel approach that measures highly abundant tumor-associated extracellular vesicles which side-steps many of the challenges encountered with cfDNA-based tests. Nearly 80% of ovarian cancer is diagnosed when disease has progressed beyond the localized stage, and only ~30% of women diagnosed with advanced disease survive for five years. We will present data from a large clinical study demonstrating detection of early-stage ovarian cancer with the Mercy Halo Ovarian Cancer test at high sensitivity and specificity in blood samples from asymptomatic post-menopausal women up to three years before manifestation of symptoms and clinical diagnosis. This data represents a significant improvement in the early detection of ovarian cancer compared to currently available technologies and suggests the test may be suitable for use in population screening for postmenopausal women, in whom 70% of ovarian cancer occurs.

The results of our ECLIPSE study, highlighting Shield's ability to detect colorectal cancer (CRC) with 83% sensitivity through a simple blood draw, will be presented. Since its introduction in May 2022, the lab-developed version of the Shield test has been utilized by over 20,000 individuals, with a completion rate of over 90% among patients prescribed the test in real-world clinical settings. These findings suggest that Shield's sensitivity in detecting CRC, coupled with high real-world adherence, could enhance the detection of earlier-stage CRC cases, compared to conventional screening methods. The clinical implications of these results, highlighting the potential of liquid biopsies in advancing CRC management and improving patient outcomes, will also be discussed.

CRC-PREVENT was a pivotal prospective, cross-sectional clinical trial comprising 8920 eligible participants. The trial evaluated the sensitivity and specificity of the mt-sRNA test compared with a colonoscopy and served as clinical validation for the premarket approval application to the FDA. The mt-sRNA test's sensitivity for detecting colorectal cancer was 94%, its sensitivity for detecting advanced adenomas was 46%, and its specificity for detecting no lesions on colonoscopy was 88%. Geneoscopy is developing additional tests that can improve early detection for subjects at higher risk for developing CRC. Currently, Geneoscopy has ongoing clinical trials in IBD, FAP, and other predisposing diseases.

The Multi-Cancer Early Detection (MCED) field is still in its beginning stages, and it shows great promise as a fundamentally novel approach to help markedly expand our ability to detect multiple cancers through routine screening. Like most disruptive technologies, MCED tests are prompting questions from patients, providers, regulators, and payers. Realizing the full potential of MCED tests means answering these questions. This session will address shared questions about MCED testing, provide insights from recent research, and discuss a roadmap to future answers.

Recent advancements have ushered in the era of "liquid biopsy," a minimally invasive alternative to traditional tissue pathology. At the UCLA Liquid Biopsy Laboratory, our research team is at the forefront of this revolution, having developed innovative technologies to isolate tumor-derived extracellular vesicles (EVs). Our approach facilitates multi-omic analysis, providing rich molecular signatures. These signatures demonstrate significant promise for the early detection and monitoring of various solid tumors, heralding a new paradigm in cancer diagnostics and management.

Early cancer discovery is challenging due to heterogeneity of different cancers and even within cancers from the same organ. In order to tackle this problem, Freenome has built a multiomics discovery platform that looks for signals along the entire central dogma—DNA, methylation, RNA, protein, immunoprofiling, extracellular vesicles, circulating cells, among others. In order to featurize, train, and build the best models that are generalizable and robust, we have created our own machine learning platform incorporating different computational biological signals. All this is aligned with a step-wise investigation of cancers that can most benefit the population and make a difference to patients, starting with colorectal cancer and advanced adenoma. During this talk, we will discuss the clinical, scientific, and computational strategy that we think is important to create the best products to benefit the most patients.

Blood-based multi-cancer early detection (MCED) tests represent a new paradigm for cancer screening. Their development addresses a significant unmet need by expanding detection to include the ~70% of cancers that are missed by current screening modalities and that result in >600,000 cancer deaths yearly in the US. MCED testing holds promise to improve screening efficiency and reduce cancer deaths. Several studies demonstrate that MCED tests have the ability to detect a broad spectrum of potentially lethal cancers, to predict the cancer type, and to do so with a very high specificity to limit false positive results.

Minimally invasive methods for colorectal cancer (CRC) screening are emerging as a compelling approach with an appeal for increasing screening compliance. However, it is critical that CRC early cancer detection (ECD) tests are associated with acceptable sensitivity and specificity in the context of the target patient population. This talk will address practical recommendations for the development of CRC ECD tests in the context of results from a development pipeline.

Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis, and management. Here we will be presenting on our proprietary 2-tier testing model that is designed to enable cost-effective population testing, reduce the burden of false positives on the healthcare system, and equip clinicians with actionable information.

Monitoring disease progression in cancer patients receiving immune checkpoint inhibitors is challenging because there are no reliable biomarkers of clinical response. Current next-generation sequencing cfDNA assays are costly and have limited sensitivity for cases with low tumor burden. Here, we demonstrate the utility of DELFI Tumor Fraction (DELFI-TF), a tumor- and mutation-independent cfDNA fragmentome approach to monitor treatment response in patients with metastatic non-small cell lung cancer (mNSCLC).