Federal Register #FDA2026N8004

FDA Announces Public Advisory Committee Meeting on GRAIL, Inc. Galleri Test

This opportunity is a public advisory committee meeting hosted by the FDA to review the premarket approval application for the Galleri test by GRAIL, Inc. - Event Details: - FDA's Molecular and Clinical Genetics Panel will evaluate the Galleri test - Focus is on regulatory review, not procurement - Public comments are invited via an established docket - Technology Overview: - Galleri test is a next-generation sequencing (NGS)-based in vitro diagnostic - Detects cancer-specific methylation patterns in cell-free DNA from blood - Intended for early detection of multiple cancer types in adults aged 50+ - Participation: - Meeting is open to the public - Opportunity for stakeholders to provide input on a significant new diagnostic technology - No procurement or purchase quantities are involved - No part numbers or product line items are listed

Description

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. The meeting will discuss and vote on the premarket approval application for the Galleri test by GRAIL, Inc., a next-generation sequencing-based in vitro diagnostic test intended for early detection of multiple types of cancer in adults aged 50 years or older. The meeting is open to the public and will be held on September 23, 2026, with opportunities for public comment until September 16, 2026. Comments can be submitted electronically or in writing, and oral presentations may be scheduled during the meeting.

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