FDA MCGP Panel Vote Backs Galleri Multi-Cancer Early Detection Test

The FDA Molecular and Clinical Genetics Panel of the Medical Devices (MCGP) advisory committee voted in favor of the premarket approval (PMA) application for the Galleri multi-cancer early detection (MCED) test for cancer screening in adults ages 50 years and older.¹

In 3 separate votes, the MCGP panel’s 10 voting members voted unanimously in support of the test’s safety; voted 7 to 2, with 1 abstention, that the benefits of Galleri outweigh its risks; and voted 6 to 4 in support of its effectiveness.

The FDA granted Galleri breakthrough device designation in 2018, and the test has also previously been granted 2 investigational device exemptions; GRAIL submitted the PMA application on January 29, 2026. These decisions were supported by data from the PATHFINDER 2 study (NCT05155605) and the NHS-Galleri trial (NCT05611632).²

Galleri is designed to detect cancer-specific methylation patterns that occur across several cancer types, including cancers without recommended screening, and to predict the cancer signal origin when a signal is detected to guide diagnostic evaluation. The test is intended to be used in addition to, not in place of, guideline-recommended screening.¹

“The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening, helping find more cancers safely, when they may be easier and less costly to treat, and it still may be possible for a patient to receive treatment with curative intent,” Josh Ofman, MD, MSHS, chief executive officer of GRAIL, said in a news release. “Today’s vote reinforces the strength of Galleri’s clinical evidence. We believe the panel’s recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test.”

What primary data were shown for Galleri across the PATHFINDER 2 and NHS-Galleri trials?

In an analysis of overall performance across both studies, Galleri showed a 12-month episode sensitivity rate of 35.0% (n = 303; 95% CI, 29.8%-40.5%) in PATHFINDER 2 and 31.6% (n = 820; 95% CI, 28.5%-34.8%) in NHS-Galleri.³ The specificity rates for each trial were 99.85% (n = 21,115; 95% CI, 99.75%-99.91%) and 99.74% (n = 49,919; 95% CI, 99.61%-99.82%), respectively, and the respective positive predictive values (PPV) were 77.0% (n = 138; 95% CI, 65.8%-85.4%) and 66.2% (n = 391; 95% CI, 56.7%-74.6%).

Moreover, the negative predictive value for the Galleri test was 99.07% (n = 21,281; 95% CI, 98.93%-99.20%) in PATHFINDER 2 and 98.89% (n = 50,347; 95% CI, 98.78%-98.98%) in NHS-Galleri. The cancer signal origin prediction accuracy rates were 94.3% (n = 100/106; 95% CI, 88.2%-97.4%) and 91.9% (n = 238/259; 95% CI, 87.9%-94.6%), respectively.

What additional data were shown in PATHFINDER 2 and NHS-Galleri?

In PATHFINDER 2, 35,878 patients with a median age of 65 years (range, 59-71) were enrolled. Among the 12 cancers that are responsible for the majority of United States (US) cancer deaths, the sensitivity rate rose to 69.8% (95% CI, 62.8%-76.0%).⁴ Across cancer types with guideline-recommended screening (n = 153), the combined 12-month episode sensitivity was 22.9% (95% CI, 16.9%-30.1%).³ Within this group, the sensitivity rates were 62.5% (95% CI, 30.6%-86.3%) for colon/rectum cancer (n = 5/8), 47.1% (95% CI, 26.2%-69.0%) for lung cancer (n = 8/17), 26.4% (95% CI, 16.4%-39.6%) for breast cancer (n = 14/53), and 10.7% (95% CI, 5.5%-19.7%) for prostate cancer (n = 8/75). Among MCED-detected cancers, 53.0% were diagnosed at stage I to II.⁴

In NHS-Galleri (n = 142,250), the primary end point of reduced stage III/IV cancer incidence after 3 annual screening rounds was not met (incidence rate ratio, 1.03; 95% CI, 0.92-1.14; P = .63).⁵

Regarding safety, across 3 screening rounds, trial- and/or device-related adverse effects (AEs) occurred in 371 patients (0.52%) in the intervention group vs 321 patients (0.45%) in the control group, and none of these AEs were serious. In the intervention group, 337 patients (0.47%) experienced trial-related AEs, 27 patients (0.04%) had device-related AEs, and 11 patients (0.02%) had AEs that were both trial and device related. All 321 patients with AEs in the control group (0.45%) had trial-related AEs. The most common trial-related AEs included bruising at the puncture site, syncope, and dizziness.

References

1. FDA Advisory Committee votes in favor of approval of GRAIL’s Galleri multi-cancer early detection test. News release. GRAIL, Inc. September 23, 2026. Accessed September 24, 2026. https://grail.com/press-releases/fda-advisory-committee-votes-in-favor-of-approval-of-grails-galleri-multi-cancer-early-detection-test/
2. GRAIL announces FDA advisory committee meeting to review premarket approval application for the Galleri multi-cancer early detection test. News release. GRAIL, Inc. August 7, 2026. Accessed September 24, 2026. https://grail.com/press-releases/grail-announces-fda-advisory-committee-meeting-to-review-premarket-approval-application-for-the-galleri-multi-cancer-early-detection-test/
3. FDA executive summary: prepared for the September 23, 2026, meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. FDA. Accessed September 24, 2026. https://www.fda.gov/media/194909/download
4. Nabavizadeh N, McDonnel C, Kurbegov D, et al. Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study. Nat Med. Published online September 22, 2026. doi:10.1038/s41591-026-04618-w
5. Sasieni P, Johnson P, Round T, et al. Effect of screening with multicancer early-detection test on late-stage cancer diagnosis. Published online September 22, 2026. N Engl J Med. 2026. doi:10.1056/NEJMoa2505723