An FDA advisory panel will meet Sept. 23 to review GRAIL’s Galleri test, a blood-based screening tool for multiple cancer types that would be the first FDA-authorized multi-cancer early detection device if approved, according to the agency’s executive summary released ahead of the meeting.
Here are eight things to know:
- Galleri detects cancer-specific DNA methylation patterns in blood and is proposed for screening adults 50 and older. A positive result also predicts the likely location of the cancer. GRAIL submitted its premarket approval application in January.
- The FDA’s review draws on two pivotal studies: PATHFINDER 2, a 25,125-person U.S. study, and NHS-Galleri, a 70,323-person randomized trial in the U.K. Across both, Galleri’s overall 12-month sensitivity for detecting cancer ranged from 31.6% to 35%, meaning it missed roughly two-thirds of cancers diagnosed within a year of testing. Specificity was above 99.7% in both studies, and the test’s false-positive rate was under 0.3%.
- Performance varied sharply by cancer type. For cancers with existing guideline-recommended screening — breast, colorectal, lung, prostate and cervical — combined sensitivity ranged from 22.9% to 27.5%. For cancer types without a recommended screening option, such as liver, pancreatic and head and neck cancers, sensitivity ranged from 37.3% to 47.3%.
- In the U.K. randomized trial, adding Galleri to standard care did not produce a statistically significant reduction in stage IV cancer diagnoses, the study’s key secondary endpoint. Confidence intervals crossed 1 for both the overall cancer group and a prespecified subgroup of 12 cancers responsible for two-thirds of U.S. cancer deaths.
- No serious device-related adverse events occurred in either study. Patients who received a positive result reported a temporary increase in anxiety that returned to baseline within 12 months.
- GRAIL has sold an earlier version of the test by prescription since 2021 as a laboratory-developed test without FDA marketing authorization. The company received breakthrough device designation in 2018.
- The FDA is asking its panel to weigh in on whether the data support labeling Galleri for “early” cancer detection specifically, whether any cancer types pose risks requiring additional label warnings and whether post-approval studies should be required.
- Health systems including Providence, HCA Healthcare and Dana-Farber have already begun using Galleri in patients at elevated cancer risk, and Alignment Health Plan became the first insurer to cover the test in 2021. GRAIL has also faced scrutiny over the test’s rollout: The company mistakenly told roughly 400 patients they may have cancer in 2024 because of a vendor software error.
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