Galleri® regulatory milestone · September 23

A favorable advisory vote.
An important distinction.

An FDA advisory committee voted 7–2, with one abstention, that the benefits of Galleri outweigh its risks. The committee also voted unanimously for safety and 6–4 for effectiveness.

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Primary sourcesGRAIL announcement FDA committee materials

The committee vote

Three questions.
One careful reading.

The committee considered the test’s overall benefit–risk profile, safety, and effectiveness. Each vote addresses a distinct question.

7–21 abstention: Benefits outweigh risksThe committee’s overall benefit–risk recommendation.
10–0Unanimous: SafetyThe committee voted unanimously in favor on the safety question.
6–4Majority: EffectivenessThe committee voted in favor on the effectiveness question.

Vote details are reported in the GRAIL announcement and supporting FDA committee materials .

Regulatory context

What the vote means—and what it does not.

What it means

The independent advisory committee reached a favorable recommendation on Galleri’s overall benefit–risk profile and voted in favor on the safety and effectiveness questions presented.

The recommendation is an important milestone in the FDA review process.

What it does not mean

The committee’s vote is not FDA clearance or approval. Galleri remains under regulatory review, and the FDA makes the final decision.

It also does not change how the test should be used today: with physician guidance and alongside—not instead of—recommended cancer screenings.

GRAIL Galleri multi-cancer early detection test boxes — Galleri® multi-cancer early detection test

About Galleri

One blood draw.
A broader screening view.

Galleri is a prescription blood test that screens for a shared cancer signal associated with more than 50 cancer types and predicts the signal’s likely tissue of origin to help guide follow-up.

01
Designed for elevated riskGenerally intended for adults age 50 or older, or adults with an elevated risk for cancer.
02
Physician guidedA physician order is required, and results should be interpreted in the context of your medical history.
03
Complementary screeningGalleri does not replace routine cancer screenings recommended by your healthcare provider.

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Important safety information

Screening adds information.
It does not provide certainty.

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. Galleri is not recommended for individuals who are pregnant, age 21 or younger, or undergoing active cancer treatment.

Galleri does not detect all cancers and should not replace routine cancer screenings recommended by your healthcare provider. A “No Cancer Signal Detected” result does not rule out cancer. False positive and false negative results do occur.

Results should be interpreted by a healthcare provider in the context of medical history. Rx only.

Regulatory status: Galleri has not been cleared or approved by the FDA.

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Your next step

Consider Galleri with clinical guidance.

Explore eligibility, ordering, and what to expect from a physician-guided Galleri test.

Order the Galleri test Review test details and safety information

A favorable advisory vote.An important distinction.

Three questions.One careful reading.