Skip to main content
Trending
Corporate earningsAi infrastructureEnergy marketsElection litigationAviation safetyCrypto securityAi governanceEnterprise aiPlatform liabilityAvian influenzaClinical trialsFederal debtPresidential runoffRpg developmentSpace debrisAir defenseAutonomous vehiclesBudget crisisBug bountiesEnergy m&aForeign investmentFranchise restructuringGene therapyPandemic treatyTranslation pathwaysUn peacekeepingWeapons testingWeight-space programmingAi copyright lawArchaeological toxicology

full timeline

Galleri multicancer blood test FDA review

Factlen Newsroom· Updated

Follow Galleri multicancer blood test FDA review in the Factlen app and get an alert when there is news. Get the app

The Galleri test analyzes cell-free DNA in a single blood draw to detect methylation patterns associated with over 50 types of cancer.From: FDA Advisory Panel Backs First Multi-Cancer Early Detection Blood Test

Share this story

Latest

By 06:25 UTC on September 26, a federal advisory committee voted 7-2 that the benefits of Grail's Galleri multi-cancer blood test outweigh its risks. The narrow vote highlighted a tension between the promise of early detection and concerns over the test's sensitivity in early-stage disease, as panelists noted the test misses approximately 85 percent of stage 1 cancers despite a specificity of nearly 100 percent.

Prior to the vote, by 10:29 UTC on September 22, Food and Drug Administration staff released briefing documents indicating they had not identified significant safety or efficacy concerns with the test. Following the release of the favorable staff report, Grail's stock price surged 34 percent.

How the story developed

The regulatory review process for GRAIL's Galleri blood test advanced on August 8 when the Food and Drug Administration scheduled a September 23 Medical Devices Advisory Committee meeting. The premarket approval application seeks what could be the first regulatory approval for a multi-cancer early detection screening tool, designed to detect over 50 types of cancer.

The test operates by analyzing cell-free DNA from a single blood draw. It is designed to identify specific methylation patterns associated with the disease.

The 10-member FDA advisory panel was unanimous on the test's safety but split on its effectiveness.From: FDA Advisory Panel Backs First Multi-Cancer Early Detection Blood Test ·

Prior to the FDA review, the test was evaluated in a massive trial conducted in the United Kingdom. The study missed its primary endpoint for reducing late-stage cancers.

Despite missing the primary endpoint, the UK trial demonstrated a 14 percent drop in stage 4 cancer diagnoses.

The test demonstrated higher sensitivity for several aggressive cancers that currently lack routine screening protocols.From: FDA Advisory Panel Backs First Multi-Cancer Early Detection Blood Test ·

A final regulatory approval would pave the way for Medicare coverage. This authorization could potentially make the screening tool accessible to millions of older adults by 2029.

What to watch

  • The Food and Drug Administration is expected to make a final regulatory decision on the premarket approval application in the coming months.

Charts, maps and images

MCED tests analyze fragments of tumor DNA circulating in the bloodstream to identify the presence and origin of cancer.From: FDA Schedules Advisory Committee Review for Galleri Multi-Cancer Early Detection Blood Test ·
While the test missed its primary endpoint, trial data showed a notable shift toward earlier-stage cancer detection.From: FDA Schedules Advisory Committee Review for Galleri Multi-Cancer Early Detection Blood Test ·
The test is designed to be used alongside existing standard-of-care screening methods.From: FDA Staff Report Finds No Major Safety Concerns With Galleri Multicancer Blood Test ·
The Galleri test analyzes cell-free DNA to identify methylation patterns associated with over 50 types of cancer.From: FDA Staff Report Finds No Major Safety Concerns With Galleri Multicancer Blood Test ·

Timeline

September 2026

  1. FDA Advisory Panel Backs First Multi-Cancer Early Detection Blood Test
  2. FDA Staff Report Finds No Major Safety Concerns With Galleri Multicancer Blood Test

August 2026

  1. FDA Schedules Advisory Committee Review for Galleri Multi-Cancer Early Detection Blood Test