Blood tests for colorectal cancer (CRC) screening may provide an accessible option to enhance adherence and lessen disease burden. This presentation will address the different recruitment strategies employed in the PROCEED-CRC decentralized study to enroll a diverse cohort and evaluate them in the context of historical barriers to trial access. Finally, preliminary findings from a blood-based assay for early CRC detection using samples from the PROCEED-CRC study will be presented.

Detection of cancer using molecular methods has proven challenging due to low tumor burden associated with early-stage cancers. This presentation will showcase a new technology workflow developed by ClearNote Health that leverages epigenomics and genomics changes in circulating free-DNA, in combination with machine learning, to enable early detection in both single cancer and multi-cancer modalities. We will also provide an update on the ongoing clinical strategy supporting the clinical validation and utility of single and multi-cancer tests.

As precision oncology advances, the role of epigenomics—particularly DNA methylation analysis—is emerging as a powerful tool for improving early cancer detection. In this session, Dr. Craig Eagle, Chief Medical Officer at Guardant Health, will delve into how epigenomic signatures, combined with machine learning, are enhancing the accuracy of blood-based tests across a range of cancer types. He’ll share insights into the latest developments in methylation-based biomarker discovery, clinical validation, and regulatory considerations, and discuss how these breakthroughs may soon integrate into routine care. Attendees will walk away with a deeper understanding of how epigenetic insights are reshaping the future of non-invasive cancer detection and patient outcomes.

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. During this talk, we will discuss the clinical, scientific, and computational strategy that we think are important to create the best products to benefit the most patients.

GRAIL's clinical development program spanning 9 clinical trials and diverse populations, including those with occupational exposure, will be presented, including the value of a molecular Cancer Signal of Origin in guiding targeted diagnostic evaluations and highlighting real-world experience with more than 350,000 Galleri tests.

An overview of the Exact Sciences MCED program development will be provided. Details of our 25,000 person ongoing real world evidence study will be described.

Currently cancer screening in the US is available for five cancers largely based on age. There is a substantial need for a personalized approach to cancer screening based on a risk profile. A Multi-Cancer Screening Test (MCaST) was developed to determine risk for 9 cancers representing 85% of all cancers diagnosed in the US. The test allows tailoring screening for these 9 cancers according to risk enhancing the prospects for their detection at an early stage. Additionally identifying subjects at increased risk can trigger preventive interventions to keep the cancer in check.

Firefighters have increased risk of cancer and tend to have earlier onset than the general population. Despite advances and advantages of liquid biopsies for early detection which make them attractive screening options, these tests are still in their infancy. After performing thousands of liquid biopsy tests among firefighters and comparing results to whole-body MRI and conventional screening, these tests lacked efficacy and were associated with drawbacks, including false negatives (missed cancers).

Self-funded employers are interested in innovative ways for their employee benefit programs to drive screening of cancers known to benefit from intervention when found early. Examples of screening programs sponsored by self-funded employers, as well as key learnings from developing them, will be presented.

The Vanguard Study is a pilot study that will enroll up to 24,000 people to address the feasibility of using multi-cancer detection (MCD) tests in future randomized controlled trials. This study aims to understand how two new types of MCD tests—the Avantect MCD Test by ClearNote Health and the Shield MCD Test by Guardant Health—work as cancer screening tests for adults without cancer. Details of the clinical trial design, challenges for the study, and questions to be addressed by the prospective trial will be discussed. Results from this trial are expected to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits of using MCD tests to screen for cancer outweigh the harms, and whether they can detect cancer early in a way that reduces deaths.

Bladder cancer is a highly recurrent cancer, with a recurrence rate (50-80%), requiring regular monitoring. The standard method for diagnosis and recurrence detection, cystoscopy with cytology, is invasive and has limited sensitivity, often delaying detection and reducing patient compliance.The BCDx test is a non-invasive urine-based liquid biopsy that improves recurrence detection. By integrating multiomic biomarker detection, including RNA and proteins, BCDx captures molecular changes linked to cancer progression. The test demonstrated 99% sensitivity, 86% specificity, and 99% NPV, enabling earlier detection, reducing reliance on cystoscopy, and improving patient outcomes.

Annual lung cancer deaths number as the highest amongst all single cancer deaths in the US. PrognomiQ is developing a blood-based test for lung cancer screening with the goal of significantly improving the rate of detection of lung cancer at the earliest stages, when potential for curative treatment is highest. Our approach leverages a novel and proprietary approach to proteomics and multiomics, which complement the genomics-based approaches under development for blood-based early cancer detection. The fundamental technology behind the approach, as well as data from current studies of our lung cancer screening test, will be presented.

Ovarian cancer is the fifth leading cause of cancer-related deaths among women, largely due to late-stage detection and low survival rates. At AOA Dx, we are pioneering a minimally invasive, multiomic liquid biopsy that integrates lipid and protein biomarkers with machine learning to detect ovarian cancer earlier in women experiencing symptoms. Our approach has demonstrated impressive performance in prospective clinical studies, showing strong potential to improve early diagnosis and healthcare efficiency. By identifying ovarian cancer at an earlier, more treatable stage, we aim to transform patient outcomes and advance the standard of care in women’s health.

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths globally and the fifth in the US. The Lancet Commission recently reported that liver cancer cases are projected to double by 2050, reaching 1.5 million, primarily driven by MASH and alcohol-related cirrhosis. Limitations in the performance of the current standard of care for secondary prevention—ultrasound—lead to late diagnoses and five-year survival rates below 20%. Additionally, the performance of DNA-based liquid biopsy tests are only at par with ultrasound. Mursla Bio’s flagship test, EvoLiver, is a non-invasive blood test for the early detection of HCC. EvoLiver is powered by the company’s pioneering Dynamic Biopsy platform, which non-invasively analyzes active biological processes within a specific organ or tissue. This is made possible through the proprietary capture and multi-omics analysis of tissue/organ-specific extracellular vesicles circulating in blood, which preserve the intracellular milieu in its original state until the point of testing. In the multi-center MEV01 study, EvoLiver demonstrated 86% early-stage sensitivity and 88% specificity for HCC, offering a promising new approach to shift detection earlier and improve patient outcomes.

Current approaches for cancer early detection predominantly rely on circulating tumor DNA, which is present at very low levels during early-stage disease, leading to low sensitivity. Our RNA-based approach enables highly sensitive and specific detection of not only early-stage cancer but also precancerous conditions.

Detecting cancer at early stages requires biomarkers that capture the full disease biology. By combining tumor-derived small RNAs with immune system–derived small RNAs, a more comprehensive and sensitive detection approach is achieved. Tumor-derived markers alone may miss early-stage disease, while immune system–derived small RNAs provide crucial signals of the body’s response. This integrated strategy enhances accuracy and sensitivity, enabling earlier and more precise cancer detection, ultimately improving patient outcomes.

• Blood-based micro RNA multi-cancer early detection test
• Data from ~14,000 for training, ~4,000 for testing, and ~2,000 for validation
• 99% sensitivity and specificity across all stages over 12 cancer types
• 96% tumor site of origin accuracy
• Currently translating into a qPCR-based format to improve speed, cost, and throughput

• Ways to improve comparability of MCED test performance for better matching to a patient’s individualized cancer risk              
• Best options for workups when cancer cannot be imaged              
• The role of single-cancer tests as reflex for positive MCED results​​

• NIH-wide SBIR and STTR programs 
• Funding opportunities for Early Cancer Detection 
• Application tips and assistance for awardees and applicants​​​​

• Challenges around existing cancer screening rate data sources – inaccuracy, inaccessibility, incompleteness
• Impact of these challenges on early detection test development 
• Proposed solutions and opportunities to get involved​​

• Trade-offs between sensitivity and specificity                
• The pros and cons of broad vs. more narrow initial training                
• Accounting for patient risk for more targeted screening​