GRAIL (GRAL) Goldman Sachs 47th Annual Global Healthcare Conference 2026 summary

Key clinical results and milestones

• Multi-cancer early detection test demonstrated significant reduction in stage four cancers, with over 20% reduction in year two and over 26% in year three of the NHS-Galleri Trial.

• More stage one and two cancers were detected in the intervention arm compared to control, highlighting improved early detection.

• Emergency room presentations for cancer were reduced by more than 25%, supporting clinical utility and potential for national coverage decisions.

• Extension of the trial's follow-up period by 12 months is underway to allow further data maturation and analysis.

• Additional follow-up data expected in the first part of next year.

Regulatory and reimbursement outlook

• Final module of the PMA was submitted to the FDA in January, with ongoing iterative review and anticipation of a decision on an AdCom.

• FDA label likely to focus on asymptomatic adults aged 50–80, with possible restrictions based on cancer types detected.

• International reimbursement strategies hinge on FDA approval, with partnerships like Samsung in Korea and ongoing distributor models in Canada and Israel.

• NHS and CMS are conducting cost and mortality analyses, with robust data packages expected to support coverage decisions.

• Commercial payers in the U.S. require FDA approval before broader adoption; legislative and rapid pathways could accelerate coverage.

Commercial strategy and market expansion

• Sales force has been expanded and is being trained on new clinical data, with volume growth included in current guidance of 22%-32%.

• Self-pay market is a major focus, with strong growth in physician offices, digital health partnerships, and direct-to-consumer channels.

• Repeat testing rates exceed 30% over 18 months, indicating strong patient engagement.

• Integration with Epic Systems Corporation is expected to facilitate ordering but will have greater impact post-FDA approval.

• International opportunities are being pursued through capital-efficient distributor models and partnerships.