FDA Panel Votes in Favor of Galleri Multi-Cancer Early Detection Test

The FDA’s Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee has voted in favor of approval of the Galleri multi-cancer early detection (MCED) test, with panelists unanimously supporting its safety, while a narrower majority supported its effectiveness.¹

The vote follows a prescheduled review of the premarket approval (PMA) application for Galleri, submitted in January 2026. In 3 separate votes, the panel’s 10 voting members evaluated the test’s safety, effectiveness, and overall benefit-risk profile. The panel voted 7 to 2, with 1 abstention, that the benefits of Galleri outweigh its risks. They voted 6 to 4 in support of Galleri’s effectiveness, and all 10 members supported its safety.

The recommendation concerns the use of Galleri as a prescription screening test for adults aged 50 years or older. The qualitative, next-generation sequencing-based test analyzes cell-free DNA from peripheral blood for cancer-specific methylation patterns. When a cancer signal is detected, the test provides a predicted Cancer Signal Origin to help guide diagnostic evaluation. The proposed use is in addition to, rather than as a replacement for, guideline-recommended single-cancer screening.

Test Performance: High Specificity Across 2 Studies

The review included data from the US-based PATHFINDER 2 study (NCT05155605) and the England-based NHS-Galleri study (NCT05611632).^2,3 Both studies prospectively used an earlier investigational version of the assay, while the performance analyses presented to the panel were based on retrospective testing of stored plasma samples with Galleri.

In PATHFINDER 2, among 303 participants with cancer diagnosed within 12 months, Galleri had a 12-month episode sensitivity of 35.0% (95% CI, 29.8%-40.5%) and specificity of 99.85% (95% CI, 99.75%-99.91%).⁴ Positive predictive value (PPV) was 77.0%, and negative predictive value (NPV) was 99.07%. The false-positive rate was 0.15%, and the number needed to screen to detect 1 cancer was 202.

In NHS-Galleri, among 820 participants diagnosed with cancer within 12 months, sensitivity was 31.6% (95% CI, 28.5%-34.8%), specificity was 99.74% (95% CI, 99.61%-99.82%), PPV was 66.2%, and NPV was 98.89%. The false-positive rate was 0.26%, and the number needed to screen was 196.

Sensitivity varied considerably by cancer type. In NHS-Galleri, sensitivity was 63.8% for lung cancer, 53.3% for colorectal cancer, 19.1% for breast cancer, and 10.7% for prostate cancer. Among cancers without guideline-recommended screening, sensitivity was 80.0% for liver and intrahepatic bile duct cancers, 75.0% for ovarian or fallopian tube cancers, 65.4% for esophageal cancer, and 46.6% for lymphoid-lineage cancers.

Diagnostic Follow-Up Remains a Consideration

The potential clinical implications of a positive MCED result were also considered during the review. In PATHFINDER 2, 159 of 218 participants (72.9%) with a Cancer Signal Detected result underwent at least 1 invasive diagnostic procedure. This included 90.6% of participants who were subsequently diagnosed with cancer and 47.8% of those without a cancer diagnosis. Biopsies were performed in 35.8% of participants, while 36.7% underwent endoscopy.

Nine participants (4.1%) experienced 10 adverse events during diagnostic evaluation. Four participants had 5 study-related adverse events, all of whom were diagnosed with cancer; none of these events was serious or considered device-related.

The panel also evaluated the test’s ability to identify cancers at earlier stages. In NHS-Galleri, 178 of 259 cancers (68.7%) detected in participants with a Cancer Signal Detected result were diagnosed at stages I through III. Sensitivity increased with advancing stage, from 13.6% for stage I disease to 34.4% for stage II, 44.3% for stage III, and 60.0% for stage IV disease. The panel noted that these stage-specific analyses may be affected by differential bias because cancers not detected by the test may be diagnosed later through clinical presentation.

Implications for MCED Testing

Of note, while the panel’s recommendation advances the regulatory review of Galleri, the final decision on the PMA remains with the FDA. The evidence considered by the panel included the test’s high specificity, variable sensitivity across cancer types, potential downstream diagnostic procedures, and the distinction between cancer detection and demonstrated improvements in cancer outcomes. If authorized, these considerations would be relevant to how clinicians communicate the potential benefits and limitations of MCED testing and approach diagnostic evaluation after a positive result.

“Earlier cancer detection remains one of the greatest opportunities to improve outcomes for patients,” stated Aaron Grossberg, MD, PhD, associate professor in radiation medicine at Oregon Health & Science University. “Continued advancement in [MCED] has the potential to expand screening options and help identify cancers at stages when treatment may be more effective.”

REFERENCES

1. FDA Advisory Committee Votes In Favor of Approval of GRAIL's Galleri® Multi-Cancer Early Detection Test. News release. GRAIL. September 23, 2026. Accessed September 24, 2026. https://tinyurl.com/ytcnsv5z

2. PATHFINDER 2: A Multi-Cancer Early Detection Study. ClinicalTrials.gov. Updated May 14, 2026. Accessed September 24, 2026. https://clinicaltrials.gov/study/NCT05155605

3. Does Screening With the Galleri Test in the NHS Reduce the Likelihood of a Late-stage Cancer Diagnosis in an Asymptomatic Population? A Randomised Clinical Trial (NHS-Galleri). ClinicalTrials.gov. Updated July 10, 2026. Accessed September 24, 2026. https://clinicaltrials.gov/study/NCT05611632

4. FDA Executive Summary: GRAIL Inc., Galleri. US Food and Drug Administration. September 23, 2026. Accessed September 24, 2026. https://tinyurl.com/4xzjmrk5