Story perspectives

FDA Panel Votes 7-2 to Assess Galleri Blood Test

By Drooid · Sep 24, 2026, 2:10 AM UTC · How we work

Summary

Story summary

The FDA’s Medical Devices Advisory Committee voted to assess Grail Inc.’s Galleri blood test.
On September 23, 2026, the panel voted 7-2 with one abstention that benefits outweigh risks.
The committee split 6-4 on whether Galleri’s effectiveness is demonstrated.
In two large trials, Galleri detected 35% of cancers in 12 months and achieved 99.85% specificity.
Grail’s shares rose 34% after FDA briefing documents were released, triggering a trading halt.

1 of 1

Story summary

The FDA’s Medical Devices Advisory Committee voted to assess Grail Inc.’s Galleri blood test.
On September 23, 2026, the panel voted 7-2 with one abstention that benefits outweigh risks.
The committee split 6-4 on whether Galleri’s effectiveness is demonstrated.
In two large trials, Galleri detected 35% of cancers in 12 months and achieved 99.85% specificity.
Grail’s shares rose 34% after FDA briefing documents were released, triggering a trading halt.