NHS-Galleri Top-Line Clinical Findings
Top-line NHS-Galleri results show a substantial reduction in Stage IV cancer diagnoses (greater than 20% reduction in rounds 2 and 3 for a prespecified group of 12 deadly cancers), increased detection of Stage I and II cancers, a fourfold higher overall cancer detection rate versus standard of care, and fewer cancers detected via emergency presentation; no serious safety concerns reported across ~70,000 participants over 3 rounds.
PATHFINDER 2 Registrational Consistency
Full PATHFINDER 2 results from 35,000 participants are consistent with prior data from the first 25,000 presented at ESMO, supporting test performance and clinical validation used in regulatory submission.
Completed PMA Submission to FDA
GRAIL completed its PMA submission to the FDA (final module submitted end of January) for Galleri, supported by PATHFINDER 2 and NHS-Galleri data; FDA previously designated the test a Breakthrough Device (2018) and a ~12-month review period is anticipated.
Commercial Volume and Revenue Growth
U.S. Galleri test volume grew 36% in 2025 to more than 185,000 tests; U.S. Galleri revenue grew 26% to $136.8 million; total 2025 revenue was $147.2 million, up 17% YoY; Q4 2025 revenue was $43.6 million, up 14% YoY; sold >57,000 tests in Q4 and ~0.5 million tests since launch.
Expansion of Prescriber Base and Go‑to‑Market Investment
Prescriber base increased to ~17,000 providers, up 30% YoY; company announced planned expansion of field sales and medical teams to accelerate commercial momentum.
Medicare Coverage Pathway Established
Federal law (Nancy Gardner Sewell Medicare MCED Screening Coverage Act) enacted, creating a Medicare pathway for FDA‑approved multi‑cancer early detection (MCED) tests — a structural positive for future reimbursement.
Improving Unit Economics and Profitability Trends
Non‑GAAP adjusted gross profit for Q4 2025 was $23.1 million (+29% YoY) and full‑year adjusted gross profit was $73.6 million (+27% YoY); Q4 adjusted EBITDA loss improved to -$71.8 million (15% improvement YoY) and full‑year adjusted EBITDA loss improved to -$320.6 million (34% improvement YoY); reiterated long‑term gross margin target of 50%–60% at scale.
Strong Cash Position and Guidance
Cash balance of $904.4 million as of Dec 31, 2025 (cash runway into 2030); reiterated 2026 guidance of Galleri sales growth of 22%–32% and 2026 cash burn not to exceed $300 million.