Journal: Cancer research communications
This prospective case series describes the initial experience of a dedicated multi-cancer early detection (MCED) clinic evaluating patients with a positive result on the Grail Galleri test at a single academic cancer center between December 2023 and January 2025.
Key points:
- Population: 14 patients with a positive MCED signal who presented for diagnostic evaluation. Median age 62.5 years; 64.3% male; 85.7% White, non-Hispanic.
- True vs false positives:
- 78.6% (11/14) had a confirmed malignancy.
- 21.4% (3/14) were false positives.
- Tumor types among confirmed cancers:
- 54.5% solid tumors.
- 45.5% hematologic malignancies.
- Over 90% of detected cancers did not have existing standard screening recommendations.
- Stage at diagnosis:
- Six cancers diagnosed at stage I/II.
- Five at stage III/IV.
- Workflow and timelines:
- Median time from MCED test result to presentation at the MCED clinic: 28 days.
- Median time from MCED clinic presentation to diagnostic resolution: 20 days.
- Test performance characteristics in this series:
- Most positive tests were true positives.
- The cancer signal origin predicted by the assay was generally consistent with the ultimately diagnosed malignancy.
Overall, this early experience suggests that a specialized MCED clinic can rapidly adjudicate positive MCED results and that, in this small cohort, most positive signals corresponded to real malignancies, often in cancers without established screening paradigms.