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# FDA Panel Backs Grail's Galleri Multi-Cancer Blood Test
- URL: https://www.fdaweb.com/fda-panel-backs-grail-s-galleri-multi-cancer-blood-test-d5161833/
- Published: 2026-09-23T16:00:00.000Z
- Updated: 2026-09-23T16:00:00.000Z
- Author: David McFarland
- Tags: Devices, Legacy-ID-D5161833, #Import 2026-09-24 19:50

An FDA advisory committee voted Wednesday to recommend approval of Grail's Galleri multi-cancer early detection blood test, voting unanimously, 10-0, that the test is safe, 6-4 that it is effective, and 7-2, with one abstention, that its benefits outweigh its risks for screening adults aged 50 and older. Additionally, the panel recommended that Galleri's labeling and promotional materials emphasize the need to continue established cancer screening procedures and avoid characterizing the test as an early detection tool without adequate supporting evidence.

In a [briefing document](https://www.fda.gov/media/194909/download?ref=fdaweb.com) released before the meeting, FDA said data showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing.

The divided effectiveness vote from the Molecular and Clinical Genetics Devices Panel reflected continuing questions about the clinical evidence supporting the test, including its ability to detect early-stage cancers, whether its use can reduce advanced cancer diagnoses or mortality, and the potential consequences of false-negative results.

The favorable recommendation represents a significant regulatory milestone for Grail, which is seeking PMA approval for a blood-based test designed to detect cancer signals across multiple cancer types using a single blood sample. Galleri analyzes cancer-specific methylation patterns in cell-free DNA and, when a cancer signal is detected, predicts the likely anatomical origin to help guide further diagnostic evaluation.

The test is intended to supplement, rather than replace, established screening procedures such as mammography and colonoscopy. A negative Galleri result does not rule out cancer, and a positive result requires additional diagnostic testing.