Grail's Galleri multi-cancer early detection blood test has received a favorable vote from a U.S. Food and Drug Administration advisory panel. The panel voted 7-2, with one abstention, that the test's benefits outweigh its risks, marking a significant milestone for blood tests designed to detect multiple cancer types. The FDA has not yet announced a date for its final decision.

A pivotal year for cancer blood tests

The U.S. Food and Drug Administration's (FDA) advisory panel voted Sept. 23 in favor of approving Grail's Galleri multi-cancer early detection blood test.

The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 7-2 that Galleri's benefits outweigh its risks, with one member abstaining. The vote represents a major milestone for multi-cancer blood tests seeking regulatory approval. The FDA has not announced when it will issue a final decision.

The vote follows several major developments in blood-based cancer screening in 2026, including findings from two large clinical studies and new legislation paving the way for Medicare coverage of FDA-approved multi-cancer detection tests.

What are multi-cancer early detection tests?

Multi-cancer early detection (MCED) tests analyze fragments of DNA and other biomarkers circulating in the blood that may indicate the presence of cancer. Some tests also attempt to identify the tissue or organ where the cancer originated.

Blood-based cancer screening tests in development generally fall into two categories. Single-cancer tests focus on a specific cancer type, such as colorectal cancer, while multi-cancer tests aim to detect signals associated with dozens of cancer types through a single blood sample.

Interest in these tests is growing partly because routine screening recommendations cover only a limited number of cancers, and screening participation remains inconsistent.

According to the American Cancer Society, 69% of women ages 45 and older were up to date on breast cancer screening in 2023. Among adults eligible for lung cancer screening, only 15% underwent screening in 2024.

Which multi-cancer blood tests are available?

More than 24 companies are developing multi-cancer detection tests, according to a May commentary published in JAMA.

Two tests are commercially available in the U.S.: Grail's Galleri and Cancerguard, developed by Exact Sciences and now owned by Abbott. Both are offered as laboratory-developed tests (LDTs) without FDA approval.

Launched in 2025, Cancerguard is intended for adults ages 50 to 84 and combines DNA and protein biomarkers.

Guardant Health also offers multi-cancer detection results as an optional add-on to its FDA-approved Shield colorectal cancer blood test. Guardant's Shield MCD and ClearNote Health's Avantect MCD are also being evaluated in studies conducted by the National Cancer Institute (NCI).

What do the latest Galleri studies show?

Two large Grail-funded studies evaluating Galleri were published Sept. 22, one day before the FDA advisory panel vote.

The PATHFINDER 2 study, published in Nature Medicine, included 35,878 adults ages 50 and older across 32 sites in the U.S. and Canada.

Led by Nima Nabavizadeh, MD, of the Knight Cancer Institute at Oregon Health & Science University in Portland, the study found that adding Galleri to recommended cancer screening increased the number of screen-detected cancers by approximately 6.5-fold.

Approximately 60% of participants who received a positive test result were subsequently diagnosed with cancer. Nearly three-quarters of the cancers detected by the test were types for which no recommended routine screening currently exists.

However, the test detected 39.3% of all cancers diagnosed within one year of testing.

Health systems report findings from real-world use

Health systems have also evaluated Galleri in patients without symptoms outside clinical trials.

In an 18-month study conducted at Mayo Clinic in Rochester, Minn., 73.3% of asymptomatic patients who received a positive result were diagnosed with cancer.

Dana-Farber Cancer Institute in Boston reported a cancer diagnosis rate of 78.6% among patients with positive results. A study conducted within a Veterans Affairs health system reported a rate of 50%.

UK trial finds no significant reduction in advanced-stage cancers

Not all studies have reported similar findings.

In the UK's NHS-Galleri trial, a randomized study involving 142,250 adults, adding Galleri to standard care did not significantly reduce the combined rate of stage 3 and stage 4 cancers, according to results published in The New England Journal of Medicine.

Participants offered the test had a 14% lower rate of stage 4 cancers. However, the increase in stage 3 diagnoses offset that difference. Researchers said additional follow-up is needed to better understand the findings.

Several FDA advisory panelists also expressed concern about marketing Galleri as an "early detection" test. They emphasized that patients should continue recommended routine cancer screenings regardless of whether they undergo multi-cancer blood testing.

A 2025 systematic review published in the Annals of Internal Medicine also concluded that evidence supporting the clinical usefulness of multi-cancer detection tests remains limited.

How much does Galleri cost? Will Medicare cover the test?

Galleri is available by prescription to adults ages 50 and older in the U.S. Its list price is $949, excluding laboratory costs.

Legislation signed Feb. 3 allows Medicare to begin covering FDA-approved multi-cancer detection tests in 2029. Coverage will depend on the Centers for Medicare & Medicaid Services (CMS) completing a national coverage determination for each test.

Under the legislation, coverage will initially apply to beneficiaries ages 50 to 64 in 2029. The upper age limit will increase by one year annually. Eligible beneficiaries may receive one test every 11 months.

The legislation also allows for the possibility of removing age limits based on recommendations from the U.S. Preventive Services Task Force (USPSTF).

National Cancer Institute launches its own multi-cancer testing study

The National Cancer Institute is conducting its own research into multi-cancer detection tests.

The Vanguard Study, the first trial launched through the agency's Cancer Screening Research Network, is designed to determine how multi-cancer tests can be evaluated in a large randomized clinical trial.

The study plans to enroll up to 24,000 adults ages 45 to 75 who have not received a cancer diagnosis within the past five years.

Researchers will evaluate two multi-cancer detection tests. The findings are expected to inform a future trial examining whether these tests can reduce cancer-related deaths.

Participants are being recruited through nine research hubs across the U.S., including the Uniformed Services University, the Department of Veterans Affairs, Henry Ford Health, Michigan State University, Kaiser Permanente, the University of Oklahoma's Stephenson Cancer Center, the University of Colorado Cancer Center, the University of North Carolina's Lineberger Comprehensive Cancer Center, Virginia Commonwealth University, Inova, Sentara Health and Washington University School of Medicine.

Multi-cancer blood tests have the potential to reshape cancer screening by detecting signals associated with multiple cancer types through a single blood sample. However, important questions remain regarding their ability to detect early-stage disease, false-positive and false-negative results, clinical benefits and whether their use ultimately reduces cancer-related mortality.