Companies
GRAIL
reported full NHS-Galleri trial results at the 2026 ASCO Annual Meeting showing a substantial reduction in stage IV cancer diagnoses and a four-fold higher cancer detection rate, presented Pathfinder 2 results from more than 35,000 participants, and has submitted an FDA PMA application for Galleri.
- Country
- United States
- Ticker
- GRAL
Growth
Galleri MCED test
Coverage
| CN | EU | US | |
|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | $110 million equity financing with Samsung C&T and Samsung Electronics completed in June 2026 (2026-06-30) | grail.com |
| Capacity | infrastructure capable of meeting demand of up to one million tests per year (2026-01-01) | investors.grail.com |
| Certification | Clinical Laboratory Improvement Amendments of 1988 (CLIA) and College of American Pathologists (CAP) accredited clinical laboratory (2026-05-30) | grail.com |
| Regulatory approval | Galleri test has not been cleared or approved by the U.S. FDA, with an advisory committee anticipated in the fall of 2026 (2026-08-05) | grail.com |
| Production site | CLIA-certified laboratory located in Research Triangle Park, North Carolina (2024-08-14) | fiercebiotech.com |
| Revenue | $44.7 million in total revenue for the second quarter of 2026 (2026-06-30) | grail.com |
Independent sources: fiercebiotech.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Multi-cancer early detection (MCED) | diagnostics-medtech | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.