An FDA advisory panel voted on September 23, 2026, in favor of approving Galleri, a blood test from GRAIL, Inc. that looks for signals of many cancers at once. The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 7 to 2, with one abstention, that the test’s benefits outweigh its risks. The vote is a recommendation only: the FDA is not bound by it and has not yet issued a final decision on the premarket approval (PMA) application GRAIL filed on January 29, 2026.
What Galleri is and who it is for
According to the FDA’s meeting materials, Galleri is a qualitative, next-generation sequencing-based test that detects cancer-specific methylation patterns in cell-free DNA from a blood sample. GRAIL proposes it for screening for the early detection of multiple types of cancer in adults aged 50 or older. A positive result (“Cancer Signal Detected”) also comes with a prediction of where in the body the signal originates. The FDA’s briefing notes that no FDA-authorized device is currently indicated for screening for multiple types of cancer. Galleri received Breakthrough Device Designation in August 2018.
How the panel voted
The panel took three separate votes:
- Safety: unanimous in support.
- Effectiveness: 6 to 4 in support.
- Benefit-risk: 7 to 2, with 1 abstention, that benefits outweigh risks.
The narrower effectiveness margin is worth noting, because it reflects the questions about test performance discussed below.
What the data actually show
The FDA’s executive summary describes two studies.
PATHFINDER 2 is a prospective, interventional, multi-center study in North American health systems, enrolling participants aged 50 or older with no clinical suspicion of cancer. It is not randomized. The analyzable set for the test-performance analysis included 25,125 participants with 12 months of follow-up as of December 31, 2024. Results in that group:
- 303 participants were diagnosed with cancer within 12 months; the test flagged 106 of them.
- 12-month episode sensitivity was 35.0% (95% CI 29.8%–40.5%).
- Specificity was 99.85%, and the false-positive rate was 0.15%.
- Positive predictive value was 77.0% (95% CI 65.8%–85.4%).
- Cancer detection rate was 0.49%.
Of the 268 participants with new primary cancers, 90 (33.6%) were detected by the test. Of 177 people diagnosed with stage I–II cancer, 44 (24.9%) were detected.
NHS-Galleri is a randomized controlled trial in England of participants aged 50 to 77, with 142,250 people randomized 1:1 to have their blood analyzed (intervention) or stored (control). For the FDA submission, the primary objective was test performance in the first screening round. There, 12-month episode sensitivity was 31.6%, specificity 99.74%, and positive predictive value 66.2%.
Limits of the evidence
- Sensitivity is reported as “12-month episode sensitivity.” The FDA explains that true cancer status at the time of the blood draw is unknown for cancers the test missed, so it is uncertain how well this figure represents true sensitivity. Stage comparisons can also be biased, since a missed cancer is staged when it is later found, possibly later than the blood draw.
- Most cancers were not flagged in the 12-month window. In PATHFINDER 2, 197 of the 303 cancers were not detected by the test. GRAIL and the FDA both stress that a negative result does not rule out cancer.
- The test used in PATHFINDER 2 was an earlier version. Results were generated with a test called MCED-V2 and not returned to participants or providers. The FDA states it considers the safety analysis an approximate estimate of Galleri’s safety profile.
- PATHFINDER 2 has no control arm. The FDA materials do not present it as showing that screening changes outcomes for patients.
Risks and harms listed
The main safety measure in PATHFINDER 2 was the diagnostic work-up triggered by a positive result. Of 218 participants who underwent diagnostic evaluation, 159 (72.9%) had at least one invasive procedure: 90.6% of those diagnosed with cancer and 47.8% of those not diagnosed with cancer. In total, 227 invasive procedures were performed, of which 89.4% were non-surgical. Among people who turned out not to have cancer, 6.0% (4 of 67) of procedures were surgical, versus 12.5% (20 of 160) among those with cancer. The median time to diagnostic resolution after a positive result was 46 days; for false positives it was 75 days.
What remains unknown
- The FDA’s final decision and its timing: GRAIL and the FDA have only said a decision is expected in the coming months.
- What labeling and warnings the FDA would require. The agency asked the panel for advice on how performance, benefits, risks, and limitations should be communicated to clinicians and patients.
- Price and insurance coverage: not addressed in the materials reviewed.
- Whether earlier detection with this test lowers cancer deaths: the FDA briefing lists a reduction in stage IV cancers as a secondary objective of NHS-Galleri, and it is not a finding in the materials reviewed here.
Why it matters
If approved, Galleri would be the first FDA-authorized multi-cancer screening blood test. GRAIL says it is intended as an addition to, not a replacement for, guideline-recommended screening. The panel’s split on effectiveness shows that even experts who backed the test differed on how well the evidence supports it. For patients, the practical question is how a positive result, a 0.15% false-positive rate and a work-up that often involves invasive procedures weigh against a test that misses most cancers within a year.
This is general information, not medical advice. Talk with your doctor about which cancer screenings are right for you.
Source: FDA Executive Summary for the September 23, 2026 meeting of the Molecular and Clinical Genetics Panel (GRAIL Galleri PMA); vote counts from GRAIL’s September 23, 2026 announcement. Meeting details: FDA advisory committee calendar.