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    Galleri (multi-cancer early detection blood test)

    Also known as Galleri, Galleri test, GRAIL Galleri, Galleri MCED

    Galleri is a prescription blood test from GRAIL that looks for cancer-specific DNA methylation patterns to screen for more than 50 cancer types and predict where a cancer signal comes from.[1] Its randomised NHS-Galleri trial missed its primary endpoint but found fewer stage IV cancers. An FDA panel backed approval in September 2026, but as of 11 October the test was not FDA-approved.[2][3][4][5]

    Editor reviewedStrict sourcingUpdated WikiHealth and medicine, Life sciences
    Key facts

    Galleri is the best-studied multi-cancer early detection (MCED) blood test. GRAIL describes it as detecting DNA fragments shed by tumours and reading their methylation patterns, both to flag a general cancer signal and to predict the organ or tissue it came from.[1] It screens for more than 50 cancer types, including pancreatic, ovarian and liver cancers that lack screening options.[1]

    This page is not medical advice. Galleri requires a prescription. Talk to a clinician about whether any screening test is right for you.

    Availability and regulation

    GRAIL launched Galleri in the US in mid-2021 as a laboratory test. FDA approval is not required to market it that way.[6] As of 11 October 2026 its site stated that it has not been cleared or approved by the FDA, and that GRAIL’s laboratory is regulated under CLIA.[5] GRAIL filed a premarket approval application on 29 January 2026. The FDA had designated Galleri a Breakthrough Device in 2018.[7] On 23 September 2026 an FDA advisory panel voted 7-2, with one abstention, that its benefits outweigh its risks. It voted unanimously on safety and 6-4 on effectiveness.[4] As of mid-2026 the test was not broadly reimbursed.[6]

    Evidence

    StudyDesignKey results
    NHS-Galleri (England)Randomised, 142,250 people aged 50–77, up to 3 annual tests (GRAIL-funded)[8]Primary endpoint (stage III–IV) not met, rate ratio 1.03; stage IV rate ratio 0.86 (95% CI 0.74–1.00)[2][3]
    NHS-Galleri performanceDescriptive secondary analysisSpecificity 99.50%–99.60%; PPV 45.8%–58.0%; episode sensitivity 26.7%–37.2% (all cancers)[9]
    PATHFINDER 2 (North America)Single-arm, 32,007 analysable adults 50+PPV 60.3%; specificity 99.64%; episode sensitivity 39.3% (all cancers)[10]

    Both trials were published in September 2026.[11][10] GRAIL reported that the stage IV reduction in NHS-Galleri grew from 9% in the first round to 26% in the third, and that adding Galleri led to a four-fold increase in screen-detected cancers.[12][13] No serious trial-related adverse events were reported.[14]

    Limits stated by the maker

    GRAIL says Galleri does not detect all cancers and should be used in addition to routine screening. A “No Cancer Signal Detected” result does not rule out cancer. It is not recommended during pregnancy, at age 21 or younger, or during active cancer treatment.[15] The PATHFINDER 2 authors say randomised trials and longer follow-up are still needed to show clinical utility.[16]

    Debate

    Independent experts disagree on what the results mean. Some see the stage IV trend as promising. Others say the failed primary endpoint and low early-stage sensitivity do not justify population-wide use.[17][18] The competing views are set out in our analysis of multi-cancer early detection. For FDA-approved single-cancer tests, see the at-home screening buyer’s guide.

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    Developing in Health

    Questions readers ask

    What is the Galleri test?

    A prescription blood test from GRAIL that analyses DNA methylation patterns in cell-free DNA to look for signals of more than 50 cancer types and predict where in the body a signal originated.[1]

    Is Galleri FDA approved?

    Not as of 11 October 2026. GRAIL filed for approval on 29 January 2026, and an FDA advisory panel voted in favour on 23 September 2026. GRAIL expects a decision in the coming months.[5][7][4]

    How many cancers does Galleri miss?

    In NHS-Galleri, episode sensitivity was 26.7% to 37.2% for all cancers diagnosed within a year, and 47.6% to 63.4% for 12 prespecified types. GRAIL says a negative result does not rule out cancer.[9][15]

    If Galleri finds a cancer signal, do I have cancer?

    Not necessarily. In NHS-Galleri about half of positive results led to a cancer diagnosis (positive predictive value 45.8% to 58.0% by round). A positive result needs diagnostic follow-up.[9][15]

    Who should not use Galleri?

    GRAIL says it is not recommended for people who are pregnant, aged 21 or younger, or undergoing active cancer treatment, and it should not replace routine screening.[15]

    Sources

    · 18 claims from 9 publishers

    Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.

    1. [1]

      Galleri is a prescription blood test that looks for cancer-specific DNA methylation patterns in cell-free DNA, screens for more than 50 cancer types, and predicts where in the body a cancer signal originated. confirmedas of 2026-10-11

    2. [2]

      NHS-Galleri missed its primary endpoint; the rate of stage III or IV cancer across 12 prespecified cancer types did not differ significantly between groups after three rounds (incidence rate ratio 1.03, 95% CI 0.92 to 1.14). confirmedas of 2026-10-11

    3. [3]

      In NHS-Galleri, the incidence rate ratio for stage IV cancer, a key secondary endpoint, was 0.86 (95% CI 0.74 to 1.00) after three rounds, a 14% reduction that GRAIL described as nominally significant. confirmedas of 2026-10-11

    4. [4]

      On 23 September 2026 an FDA advisory panel voted 7-2 with one abstention that Galleri's benefits outweigh its risks, unanimously on safety, and 6-4 on effectiveness, for screening adults aged 50 and older; the FDA is not bound by the vote. confirmedas of 2026-09-23

    5. [5]

      As of 11 October 2026 Galleri's own site stated that the test has not been cleared or approved by the FDA; it is sold as a laboratory-developed test under CLIA and requires a prescription. confirmedas of 2026-10-11

    6. [6]

      GRAIL launched Galleri in the US in mid-2021; as of mid-2026 it was not broadly reimbursed, and FDA approval was not required to market it. confirmedas of 2026-08-06

    7. [7]

      GRAIL submitted a premarket approval (PMA) application for Galleri to the FDA on 29 January 2026; the FDA had designated Galleri a Breakthrough Device in 2018. confirmedas of 2026-10-11

    8. [8]

      NHS-Galleri randomised 142,250 people aged 50 to 77 in England (71,122 intervention, 71,128 control) to up to three annual Galleri blood tests on top of usual care or to stored blood; it was funded by GRAIL. confirmedas of 2026-10-11

    9. [9]

      Across NHS-Galleri's three rounds, specificity was 99.50% to 99.60%, positive predictive value fell from 58.0% to 45.8%, and episode sensitivity was 26.7% to 37.2% for all cancers and 47.6% to 63.4% for the 12 prespecified types. confirmedas of 2026-10-11

    10. [10]

      In PATHFINDER 2 (32,007 performance-analysable North American participants aged 50 or older), Galleri's cancer detection rate was 0.54%, positive predictive value 60.3%, specificity 99.64%, and episode sensitivity 39.3% for all cancers and 69.8% for 12 prespecified cancers; it was a single-arm study. confirmedas of 2026-10-11

    11. [11]

      GRAIL presented full NHS-Galleri results at the ASCO Annual Meeting on 30 May 2026; the main results and performance data were published in NEJM and Nature Medicine on 22 September 2026. confirmedas of 2026-10-11

    12. [12]

      GRAIL reported that stage IV diagnoses of the 12 prespecified cancers fell 9%, 22% and 26% in the first, second and third screening rounds, while stage III diagnoses rose, especially in the first round. confirmedas of 2026-10-11

    13. [13]

      GRAIL reported that adding Galleri to standard screening led to a four-fold increase in screen-detected cancers in NHS-Galleri. confirmedas of 2026-10-11

    14. [14]

      Fewer than 1% of NHS-Galleri participants had trial-related adverse events and none were serious. confirmedas of 2026-10-11

    15. [15]

      GRAIL says Galleri should be used in addition to routine screening, a negative result does not rule out cancer, a positive result needs diagnostic confirmation, and it is not recommended in pregnancy, at age 21 or younger, or during active cancer treatment. confirmedas of 2026-10-11

    16. [16]

      The PATHFINDER 2 authors state that randomised trials and longer follow-up are needed to assess the clinical utility of MCED tests. confirmedas of 2026-10-11

    17. [17]

      Nitzan Rosenfeld (Queen Mary University of London) said the strengthening stage IV reduction in later rounds suggests late-stage reductions might accumulate with longer screening, but that this remains untested and stage-shift endpoints are confounded by lead-time bias. confirmedas of 2026-05-30· interpretation

    18. [18]

      Some senior cancer researchers, including Houlston and NCI Director Anthony Letai (as reported by The Cancer Letter in October 2026), have said the current data do not support population-wide use of MCED tests. reportedas of 2026-10-09· interpretation

    Revision history (1)
    1. Page created.

    Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Nov 11, 2026.

    Cite this page

    "Galleri (multi-cancer early detection blood test)." ContentLora, updated Oct 11, 2026. https://contentlora.com/wiki/galleri-test

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