Lung cancer remains the deadliest cancer, yet early detection is achieved in only 28% of cases. Low-dose CT screening lowers mortality but yields a 96.1% false-positive rate and is underused, with just a 18% participation rate. Existing ctDNA "liquid biopsies" detect fewer than 20% of early cancers. CIZ1B, a protein variant strongly associated with early-stage lung cancer, offers a promising alternative. Moffitt Cancer Center and Cizzle Biotechnology are conducting a 250-patient study (140 enrolled) assessing its ability to distinguish benign from malignant lung nodules under 4 cm, monitor recurrence, and identify residual disease using a simple blood test.

• Ovarian cancer (OC) is frequently diagnosed at advanced stages due to non-specific symptoms that cause delays in imaging and specialist referral. 
• We developed a serum-based multiomic assay integrating lipid and protein biomarkers with machine learning to detect early-stage OC in symptomatic women. 
• In a prospective multi-site study, our assay detected early-stage disease with >90% sensitivity and 82% specificity.
• This assay will enable earlier triage and diagnosis in a symptomatic clinical population.?

Mercy BioAnalytics has developed and validated a simple blood test for ovarian cancer screening in postmenopausal women that exhibits unprecedented clinical performance in the intended use population. We will review clinical data, including acceleration in time to diagnosis, and superiority vs. existing modalities in head-to-head studies. Physician and patient experience with the LDT being offered through our Early Access Program will be discussed, along with progress of our PMA submission.

Liver cancer is the fastest-growing and fifth-deadliest cancer in the United States. Early detection is key, but current testing is suboptimal. The current standard of care (ultrasound plus AFP blood testing) misses up to 75% of cases—a major public health failure. The five-year survival rate for early liver cancer, when treated, is 31% versus just 11% for late-stage disease. Missing the early detection window leads to costs that can exceed $100,000 per patient in the first year after diagnosis. How can we change patients’ outcomes and reduce the liver cancer disease burden on payers through early detection?

Cancer predisposition is increasingly recognized in pediatric cancer patients, and early identification is critical for precision patient management. At the Children’s Hospital of Philadelphia, underlying germline susceptibility can be identified through tumor-only sequencing followed by germline confirmation or via paired tumor–normal sequencing. We analyzed clinical and genomic data from over 3,200 pediatric patients undergoing these tests. This talk will summarize the prevalence of cancer predisposition in this cohort, discuss detection strategies and challenges, describe how these results are integrated into routine clinical care, and share our institutional experience.

Early detection remains a critical challenge in improving outcomes for brain and other hard-to-diagnose cancers. A novel liquid biopsy platform integrates multiomic spectral analysis with machine learning to enable early-stage detection beyond circulating tumor DNA approaches. Supported by large-scale clinical validation and regulatory approval in brain cancer, this rapid, low-volume blood test has the potential to transform diagnostic pathways and improve access to early intervention for less survivable cancers.

We have demonstrated capturing epigenetic “noise,” rather than only fixed methylation changes, could underpin a new generation of noninvasive cancer screening assays. We seek to focus on practical steps and hurdles for moving from research assay to regulated tests:

• How can epigenetic instability metrics be integrated with existing mutation—and fragmentomics-based cfDNA tests?
• What are the critical steps for validating this approach across diverse populations and cancer types?
• How might longitudinal epigenetic instability tracking inform risk stratification and early intervention?
• What technical and regulatory challenges must be addressed to translate instability-based assays into routine clinical practice??