Guardant Health (GH) UBS Genomic Medicine Summit summary

Market opportunity and company approaches

• Cancer screening represents a vast total addressable market due to the broad, healthy patient population targeted.

• Panelists represent diverse approaches: liquid biopsy, RNA-based detection, epigenetics, and fragmentomics.

• Each company prioritizes different lead indications based on unmet needs and regulatory pathways.

• Accessibility, cost, and reimbursement are central to product strategy and market entry.

Technology and clinical focus

• Liquid biopsy technologies are advancing, with some focusing on ctDNA, others on RNA or fragmentomics for early detection.

• AI and machine learning are increasingly used to enhance sensitivity and specificity.

• Companies are targeting cancers with high mortality and limited screening options, such as lung, colorectal, pancreatic, and ovarian cancers.

• Tests are designed for high-risk populations or to complement existing modalities, e.g., dense breast tissue in mammography.

Regulatory and reimbursement strategies

• FDA approval is a major milestone, requiring large, prospective clinical trials and close collaboration with regulators.

• Companies are pursuing both LDT and IVD pathways, with some already achieving FDA Breakthrough Designation.

• Reimbursement strategies include targeting USPSTF ratings and leveraging cost advantages for early adoption.

• Real-world evidence and clinical utility studies are prioritized to support payer and physician adoption.