Guardant Health (GH) TD Cowen 46th Annual Health Care Conference summary

Business performance and growth outlook

• 2025 saw exceptional growth, with accelerating momentum expected to continue into 2026, driven by multiple products gaining market traction.

• Guardant360 experienced 25% volume growth in 2025, with 30% in the second half; 2026 guidance is for 20% growth, supported by deeper market penetration and new applications.

• Reveal volumes grew over 80% in late 2025, with strong expectations for 2026, especially as new applications and reimbursement catalysts emerge.

• SHIELD is projected to more than double its 2025 volume in 2026, supported by expanded sales force and the Quest partnership.

• All business segments are described as “firing on all cylinders,” with continued innovation and market adoption anticipated.

Product innovation and portfolio strategy

• Transition to a smart liquid biopsy platform with broad epigenetic profiling is driving innovation and adoption.

• Multiple new applications are planned for launch, with over a dozen in the pipeline, enhancing clinical utility and physician engagement.

• Reveal Ultra will launch in 2026, expanding into tumor-informed MRD testing.

• The portfolio is evolving from individual tests to an integrated platform, improving patient management and customer retention.

• The app ecosystem allows tailored solutions for different cancer types, supporting diverse clinical needs.

Regulatory and reimbursement developments

• FDA approval for the flagship liquid biopsy test is expected in the second half of 2026, consolidating the portfolio and simplifying ordering.

• FDA approval will also enable a new ADLT rate in 2027, potentially boosting both liquid and tissue test volumes and financial performance.

• Medicare coverage for Reveal breast and reimbursement for therapy response monitoring are anticipated as major volume catalysts.

• ACS guideline endorsement for SHIELD is expected soon, which could drive significant volume and commercial reimbursement, especially in states mandating ACS compliance.