Journal · Cancer screening
FDA advisers back a blood test for 50 cancers. What it can and cannot do.
On September 23, an FDA advisory panel voted to support Galleri, GRAIL’s blood test for more than 50 types of cancer. It is a real step toward the first approved test of its kind, and a smaller one than the headlines suggest.
What the panel decided
The FDA’s Molecular and Clinical Genetics Devices Panel voted 7 to 2, with one abstention, that the test’s benefits outweigh its risks.1 The vote on safety was unanimous. The vote on effectiveness was closer, 6 to 4.
The use on the table is narrow: screening adults 50 and older, in addition to the cancer screenings already recommended for them and never in place of them. Panelists asked that the label say so plainly.2 The FDA usually follows its advisers, though it is not required to,3 and GRAIL expects a decision in the coming months.1
How the test works
Tumors shed fragments of their DNA into the bloodstream. Galleri reads chemical tags on those fragments, known as methylation patterns, which differ between cancer cells and healthy ones. When it finds a cancer signal, it also predicts where in the body the cancer most likely started, so the follow-up can begin in the right place.
It takes a single blood draw. In the US it is available now by prescription, at a list price of $949.4
What the studies show
Two large studies carried the application.
PATHFINDER 2 followed 35,878 adults aged 50 and over in North America.5 When the test flagged a cancer signal, 60.3% of those people turned out to have cancer, and its call on the organ of origin was right 91.3% of the time. Fewer than 0.4% of people without cancer received a false alarm. Nearly three quarters of the new cancers it found were types for which the US has no recommended screening test.
NHS-Galleri, run within England’s National Health Service, enrolled 142,250 people aged 50 to 77 and tested half of them once a year for three years.6 It missed its main goal: there was no statistically significant drop in cancers diagnosed at stage III or IV combined. GRAIL reports that stage IV diagnoses fell by 14% overall, with the drop growing from one round of testing to the next.
What it cannot do yet
It misses most cancers. In PATHFINDER 2 it caught 39.3% of all cancers diagnosed within a year of the test, and 69.8% of twelve of the deadliest types.5 It also struggles most with early-stage cancers, NPR reported of both studies.3
There is no proof yet that it saves lives. Neither study has shown fewer deaths from cancer.7 Finding cancer earlier is the hope; fewer deaths would be the proof, and those data do not exist yet. One of the sharpest warnings came from Philip Castle, who directs the National Cancer Institute’s Division of Cancer Prevention: “Routine approval and broad population rollout would risk harm and waste resources.”3
A positive result starts a search. About four in ten positive results in PATHFINDER 2 were false alarms. Resolving a positive result took a median of 48 days of scans and tests, and 0.6% of participants had an invasive procedure such as a biopsy.5
A negative result is not a clean bill of health. Because it misses so many cancers, it cannot stand in for a colonoscopy, a mammogram, a Pap or HPV test, a low-dose CT scan for long-time smokers, or a conversation with your doctor about PSA.
Cost and coverage
GRAIL says most health insurance plans do not cover the test, and Medicare does not cover it today.4 A law signed in February 2026 allows Medicare to cover FDA-approved multi-cancer tests from 2028 at the earliest.8 HSA or FSA funds may be an option; your plan administrator can confirm.
If you are 50 or older and weighing it
- Keep the screenings you are due for. They are the ones with decades of evidence behind them.
- Treat the blood test as an extra layer, and decide with a physician who knows your history, your family history and your other results.
- Before you test, ask what a positive result would set in motion: which scans, where, and who coordinates them.
- If the result is negative, change nothing else in your plan.
Where a screening morning fits
The most dependable protection is still the unglamorous kind: the right examinations, done well and read by specialists. A screening morning at Dr. Rose Private Hospital in Budapest brings the imaging, the blood work and the specialists into one building. Each specialist reviews findings with you in person the same day.
If you are weighing a multi-cancer blood test, bring the question with you. It is the kind of decision best made with a physician who has just seen all of your results.
Plan your screening
Three programs, every specialist under one roof, in one morning in Budapest.
General information, not medical advice. Danube Private Health coordinates screenings and is not a healthcare provider.
Sources
- GRAIL. FDA Advisory Committee votes in favor of approval of GRAIL’s Galleri multi-cancer early detection test. September 23, 2026.
- Becker’s Hospital Review. FDA panel backs first multi-cancer blood test: what to know. September 2026.
- NPR. FDA advisory panel recommends a first: multi-cancer blood test. September 23, 2026.
- Galleri. How much does the Galleri test cost? Accessed September 2026.
- GRAIL. PATHFINDER 2 results in more than 35,000 participants, 2026 ASCO Annual Meeting. 2026.
- GRAIL. Full results from the NHS-Galleri trial, 2026 ASCO Annual Meeting. May 30, 2026.
- BJC Reports. Outcomes from the NHS-Galleri trial: the good, the bad, and the uncertain. 2026.
- AJMC. Bipartisan support secures MCED coverage in Medicare. 2026.