Federal Register #FDA-2026-N-8004

FDA Public Meeting: Review of GRAIL Galleri Test for Early Cancer Detection

This is a public advisory committee meeting announced by the FDA regarding the premarket approval application for the Galleri test by GRAIL, Inc. - Event Details: - Hosted by the Food and Drug Administration (FDA), Department of Health and Human Services - Focuses on the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee - Main topic is the Galleri test, a next-generation sequencing (NGS)-based in vitro diagnostic - The Galleri test is designed for early detection of multiple cancers in adults aged 50 and older - The test detects cancer-specific methylation patterns in cell-free DNA from blood samples - Participation: - Open to the public with both in-person and online attendance options - Public comments can be submitted via an established docket - Procurement/Industry Impact: - No procurement or solicitation for products or services is involved - No purchase quantities, part numbers, or contract values are listed - GRAIL, Inc. is the only OEM/vendor mentioned, as the developer of the Galleri test - Purpose: - To review and discuss the scientific and clinical evidence for the Galleri test's premarket approval - To gather input from experts and the public on the test's safety and effectiveness

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 Committee provides advice and recommendations to FDA regarding medical devices related to molecular and clinical genetics. The meeting will discuss the premarket approval application for the Galleri test, 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 will be open to the public and will include options for online participation and public comment via a docket.

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