A pivotal year for cancer blood tests
An FDA advisory panel voted Sept. 23 in favor of approving Grail’s Galleri multi-cancer early detection blood test, marking the first time a blood test of this kind has reached that stage of review.
The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 7-2, with one abstention, that Galleri’s benefits outweigh its risks. The FDA has not said when it will make a final decision.
The vote follows a series of 2026 developments in blood-based cancer screening, including results from two large trials and a new law paving the way for Medicare coverage of multi-cancer detection tests.
What are multi-cancer early detection tests?
Multi-cancer early detection tests look for fragments of DNA and other biomarkers in the blood that may signal cancer. Some also predict where in the body the cancer started.
Most blood-based screening tests in development fall into two groups: single-cancer tests, such as those for colorectal cancer, and multi-cancer tests, which look for signals from dozens of cancer types.
Interest in multi-cancer tests stems from gaps in screening. Routine screening is recommended for only a few cancer types, and uptake varies: According to the American Cancer Society, 69% of women 45 and older were up to date on breast cancer screening in 2023, while only 15% of adults eligible for lung cancer screening were screened in 2024.
Which multi-cancer blood tests are available?
More than 24 companies are developing multi-cancer detection tests, according to a May commentary in JAMA.
Two tests are commercially available in the U.S., both as laboratory-developed tests without FDA approval: Galleri and Cancerguard. Cancerguard, developed by Exact Sciences and now owned by Abbott, launched in 2025 for adults 50 to 84 and combines DNA and protein biomarkers.
Guardant Health also offers multi-cancer 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 both being studied by the National Cancer Institute.
What the latest studies show
Two large Grail-funded studies of Galleri were published Sept. 22, prior to the FDA panel vote.
PATHFINDER 2, a study of 35,878 adults 50 and older at 32 sites in the U.S. and Canada, was published in Nature Medicine. The study, led by Nima Nabavizadeh, MD, of Portland-based Oregon Health & Science University’s Knight Cancer Institute, found that adding Galleri to recommended screenings increased the number of screen-detected cancers about 6.5 fold.
About 60% of participants with a positive result were diagnosed with cancer, and nearly three-quarters of the cancers the test found were types without recommended screening. The test detected 39.3% of all cancers diagnosed within a year of testing.
Health systems have also reported results from offering the test to patients outside of trials. In an 18-month study at Rochester, Minn.-based Mayo Clinic, 73.3% of patients without symptoms who received a positive result were diagnosed with cancer. Boston-based Dana-Farber Cancer Institute reported that 78.6% of patients with positive results were diagnosed with cancer, and a Veterans Affairs health system study reported 50%.
In the U.K.’s NHS-Galleri trial, a randomized study of 142,250 adults, adding Galleri to standard care did not significantly reduce stage 3 and 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, but more stage 3 diagnoses offset that difference. Researchers said further follow-up is needed.
Several FDA panelists agreed Galleri should not be marketed as an “early” detection test and that patients should continue routine screenings. A 2025 systematic review published in the Annals of Internal Medicine found that data supporting the clinical usefulness of multi-cancer tests are lacking.
How much do multi-cancer blood tests cost? Will Medicare cover them?
Galleri is available by prescription to adults 50 and older at a list price of $949, which does not include laboratory costs.
Under a law signed Feb. 3, Medicare can begin covering FDA-approved multi-cancer tests in 2029 once CMS completes a national coverage determination for each test.
Coverage phases in by age. In 2029, coverage applies to beneficiaries ages 50 to 64, with the upper age limit rising by one year annually. Beneficiaries may receive one test every 11 months, and age limits could be lifted based on recommendations from the U.S. Preventive Services Task Force.
How the federal government is testing multi-cancer blood tests
The National Cancer Institute is running its own study of multi-cancer tests. The Vanguard Study, the first trial from the agency’s Cancer Screening Research Network, is designed to test whether multi-cancer tests can be evaluated in a large randomized trial.
The study plans to enroll up to 24,000 adults ages 45 to 75 who have not had a cancer diagnosis in the past five years. It will evaluate two multi-cancer tests and results will inform a future trial on whether the tests reduce cancer deaths.
Participants are being enrolled at nine hubs nationwide:
- Department of Defense Uniformed Services University (Bethesda, Md.)
- Department of Veterans Affairs (Washington, D.C.)
- Henry Ford Health (Detroit) and Michigan State University Health Sciences (East Lansing)
- Kaiser Permanente Northern California (Oakland), Kaiser Permanente Southern California and Kaiser Permanente School of Medicine (Pasadena)
- OU Health Stephenson Cancer Center at the University of Oklahoma Health Sciences Center (Oklahoma City)
- University of Colorado Cancer Center (Aurora), Kaiser Permanente Colorado (Denver) and Kaiser Permanente Hawaii (Honolulu)
- University of North Carolina Lineberger Comprehensive Cancer Center (Chapel Hill)
- Virginia Commonwealth University (Richmond), Inova (Falls Church) and Sentara Health (Norfolk)
- Washington University School of Medicine (St. Louis)
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