GRAIL presents PATHFINDER multi-cancer early detection screening study results

FDA grants breakthrough device designation for Natera’s MCED assay

FDA has granted the Breakthrough Device designation to Natera Inc.’s multi-cancer early detection assay. The BDD is designed for novel technologies that could enable more effective diagnosis, treatment of life-threatening, or irreversibly debilitating diseases or conditions.

October 23, 2026

Vol.52 No.39

Podcast

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

As the oncology community waits with bated breath for a possible FDA approval of GRAIL’s Galleri test, NCI Director Anthony Letai has a lot to say about multi-cancer detection tests—particularly Galleri.

October 14, 2026

NCI Regulatory News

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

As the debate around Galleri, the multi-cancer detection test developed by GRAIL Inc., rages on, fueled most recently by the full-steam-ahead support it has received from regulatory and legislative bodies, NCI Director Anthony Letai has turned his attention to the available data.

The Galleri MCD vote: What FDA asked its advisors to ignore

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, Jacquelyn Cobb, managing editor, discuss the Sept. 23 meeting of the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, during which the panel voted in favor of Galleri, the multi-cancer detection test from GRAIL Inc., to become the first multi-cancer detection test to receive regulatory approval.

September 30, 2026

News Analysis Regulatory News

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

The FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted in favor of Galleri to become the first multi-cancer detection test to receive regulatory approval.

September 25, 2026

Vol.52 No.35

By Jacquelyn Cobb and Sara Willa Ernst

Drugs & Targets

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

FDA announced a forthcoming hybrid meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on Sept. 23 to discuss, make recommendations, and vote on information regarding the premarket approval application for the Galleri test sponsored by GRAIL, Inc.

August 14, 2026

Vol.52 No.32

GRAIL presents PATHFINDER multi-cancer early detection screening study results

YOU MAY BE INTERESTED IN

FDA grants breakthrough device designation for Natera’s MCED assay

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

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GRAIL presents PATHFINDER multi-cancer early detection screening study results

YOU MAY BE INTERESTED IN

FDA grants breakthrough device designation for Natera’s MCED assay

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claimsClinical benefit will not be considered for approval, FDA says

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

Never miss an issue!

Login

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says