· · 2 sources ·Updated

FDA advisers vote to recommend Grail blood test for cancer screening

An FDA advisory panel voted on Wednesday to recommend approval of the Galleri multi-cancer blood test developed by Grail.

STAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks
File photo STAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks Photo: STAT

Panel endorses test safety

The independent experts concluded that the benefits of using the test outweigh its risks. They voted unanimously with a score of 10 to 0 that there is reasonable assurance the product is safe.

Effectiveness and benefit votes

Advisers split on effectiveness, voting 6 to 4 that the test provides reasonable assurance it works. A separate vote of 7 to 2 with one abstention confirmed the benefits exceed risks for eligible patients.

FDA approval process continues

The agency is not required to follow this advice but often does so in practice. Grail stated its Galleri test can detect up to 50 forms of cancer.

All 2 outlets report consistently

No differences in figures, names or dates across these reports.

  • NPR
  • STAT

Reported by

2 independent outlets. Headlines as published. Links open the original report.