Strong Volume and Screening Revenue Growth
Galleri tests sold: >56,000 in Q1 2026, a 50% year-over-year increase. Galleri screening revenue: $39.8M, up 37% year-over-year. Total revenue: $40.8M, up 28% year-over-year (includes $1.0M development services).
Improved Unit Economics and Gross Profit
Non-GAAP adjusted gross profit of $19.7M in Q1 2026, an increase of $5.4M or 38% year-over-year. Margin improvement driven by fixed cost leverage from higher volumes and reduced sample reprocessing costs.
Progress on Adjusted EBITDA and Cash Position
Adjusted EBITDA was negative $79.9M, an improvement of $18.8M or 19% year-over-year. Cash balance of $823.1M at quarter end, providing multi-year runway to pursue milestones and commercialization.
Regulatory Milestone: PMA Submission Accepted
FDA PMA submission for Galleri was accepted for review (PMA includes ~25,000 PATHFINDER 2 participants with 1-year follow-up and the prevalence round of NHS-Galleri, plus a bridging analysis). Company notes ongoing iterative review and constructive interactions with FDA.
Large Evidence Base and Upcoming Data Readouts
More than 174,000 individuals included in studies supporting the PMA; PATHFINDER 2 (35,000 participants) and NHS-Galleri (140,000 participants) full results to be presented at ASCO. Commercial and study testing yields consistent results across hundreds of thousands of tests.
Clinical Utility Findings from NHS-Galleri
NHS-Galleri topline: increase in detection of Stage I/II deadly cancers and a fourfold higher cancer detection rate compared to standard of care screening alone; meaningful reductions observed in Stage IV diagnoses and emergency presentations of cancer.
Commercial Partnerships and System Integrations
Expanded partnerships with major health systems (Dana-Farber, Cleveland Clinic, Duke, OHSU, Rush, Intermountain), digital-health partners (Function Health, Hims & Hers, WHOOP, Everlywell) and employers. Integrations with Quest and Athena have enabled ~2,000 providers to order via those platforms, yielding >30,000 tests through those integrations; Epic Aura integration announced (targeting ~450 Epic health systems eligible) to streamline ordering and results in EHRs.
Sales Force Expansion
Planned expansion of field sales and medical teams to increase territories from ~90 to 120; majority of new sales personnel expected to be onboarded and trained by midyear to drive further commercial momentum.