GRAIL, a company focused on multi‑cancer early detection, posted third‑quarter 2025 results that showed total revenue of $36.2 million, a 26 % year‑over‑year increase. Galleri revenue, the company’s flagship test, rose 29 % to $32.8 million, with U.S. sales at $32.6 million, reflecting a 28 % growth in the domestic market.
The company’s Galleri test volume climbed 39 % year‑over‑year to more than 45,000 tests, underscoring continued commercial uptake of the platform. The growth is driven by expanding availability in Canada and a partnership with Samsung that is opening key Asian markets.
Despite the revenue gains, GRAIL posted a net loss of $89.0 million for the quarter. Non‑GAAP adjusted gross profit reached $20.0 million and non‑GAAP adjusted EBITDA was $(71.7) million, reflecting the company’s ongoing investment in commercialization and regulatory activities.
GRAIL confirmed that it will file a pre‑market approval (PMA) submission for Galleri with the FDA in the first quarter of 2026. The company’s cash position remains strong, exceeding $850 million, bolstered by proceeds from a recent private placement.
Management highlighted that the company’s commercial strategy is focused on scaling the Galleri platform while maintaining cost discipline. The company’s guidance for the remainder of 2025 remains unchanged, indicating confidence in continued growth and a clear path toward regulatory approval.
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