GRAIL makes Galleri, a blood-based multi-cancer early detection (MCED) test that screens asymptomatic adults for cancer signals across more than 50 cancer types from a single blood draw. Galleri also predicts where in the body the cancer signal originated — a capability GRAIL calls Cancer Signal of Origin (CSO) — which allows physicians to direct diagnostic follow-up efficiently. The test is designed for adults over 50, used alongside existing single-cancer screenings. Galleri is sold as a laboratory-developed test (LDT) from GRAIL's CLIA-certified lab in Durham, North Carolina. GRAIL sells through multiple channels: self-insured employers, health systems, digital health platforms, life insurers, and early-adopter commercial payors. As of end of 2025, GRAIL has sold more than 475,000 Galleri tests since its mid-2021 launch, with more than 185,000 tests sold in 2025 alone. Revenue is primarily driven by test volume, as Galleri is not yet broadly reimbursed by Medicare or large commercial insurers. The key financial inflection point is FDA approval — GRAIL submitted its Pre-Market Approval application in January 2026 — followed by Medicare coverage under a newly enacted federal law that creates a pathway for CMS to cover FDA-approved MCED tests as early as 2029. GRAIL also earns a small portion of revenue from biopharma partnerships that use its methylation platform for clinical research. A perpetual royalty obligation to Illumina, currently suspended until December 2026, will resume and weigh on gross margins going forward.