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# Panel to Review Next-Gen Cancer Detector Test
- URL: https://www.fdaweb.com/panel-to-review-next-gen-cancer-detector-test/
- Published: 2026-08-07T12:00:00.000Z
- Updated: 2026-09-14T13:44:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161595

FDA is [announcing](https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-23-2026-molecular-and-clinical-genetics-panel-medical-devices-advisory-committee-meeting?utm%5Fmedium=email&utm%5Fsource=govdelivery) a 9/23 meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to vote on a Grail PMA for the Galleri test. The test is described as a prescription-only qualitative, next-generation sequencing-based in vitro diagnostic test intended to detect cancer-specific methylation patterns in cell-free DNA isolated from peripheral whole blood.

The test is intended for screening for the early detection of multiple types of cancer in adults aged 50 years and older. It is also intended to predict where a cancer signal may have originated in the body to assist a healthcare professional in their subsequent diagnostic workup.

The company says the test can screen for 50+ cancers with a single blood test. It works by identifying DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer.