(RTTNews) - GRAIL, Inc. (GRAL) announced that the U.S. FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet on September 23, 2026 to review the company's Premarket Approval application for Galleri, its multi-cancer early detection (MCED) blood test.

Galleri is designed to detect cancer-specific methylation patterns across multiple cancer types before symptoms appear, including cancers that currently lack recommended screening methods. When a cancer signal is identified, the test can predict its origin with high accuracy, helping guide further diagnostic evaluation. Importantly, Galleri is intended to complement, not replace, existing guideline-recommended screenings.

GRAIL emphasized the urgent need for improved screening, noting that 70-80% of cancer deaths occur from cancers without standard screening options. The company highlighted data from multiple studies showing Galleri's ability to increase detection rates, maintain a low false positive rate, and accurately predict cancer signal origin.

The FDA submission includes results from the PATHFINDER 2 study, which followed 25,490 participants for one year, and data from over 70,000 participants in the NHS-Galleri trial, the largest randomized controlled study of an MCED test in an intended use population. Galleri was previously designated a Breakthrough Device by the FDA in 2018.

"Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations," said Josh Ofman, CEO of GRAIL. "We look forward to discussing Galleri's clinical data to the Advisory Committee and discussing its potential to address a significant unmet public health need".

This upcoming FDA advisory committee meeting represents a critical step in advancing Galleri toward potential approval, which could mark a major milestone in transforming cancer screening and early detection.

GRAL has traded between $29.95 and $118.84 over the past year. The stock closed Friday's trading at $69.48, up 9.59%.

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