--- title: FDA Advisory Panel Backs the First Blood Test That Screens for Many Cancers at Once description: An FDA advisory panel voted to recommend approval of Galleri, the first blood test that screens for many cancers at once. What the vote means for you. author: Dr Marina Nani (Editor-in-Chief) date: 2026-09-24T10:33:34.882Z updated: 2026-09-24T10:33:34.896Z canonical: https://richhealthmagazine.com/article/fda-panel-galleri-multi-cancer-blood-test image: https://cdn.nanimediahouse.com/pexels-nurse-performing-blood-draw-with-blue-gloves-in-medical-clin-35645525.jpg categories: Longevity & Science content_type: News region: United States publication: Rich Health Magazine schema_type: Article --- An FDA advisory committee voted on September 23, 2026 to recommend approval of a blood test designed to screen for many types of cancer in a single draw, the first time a US expert panel has backed a test of this kind. The Molecular and Clinical Genetics Devices Panel voted 7 to 2, with one abstention, that the benefits of GRAIL's Galleri test outweigh its risks. The FDA is not bound by that advice, and its final decision on approval is still pending. Galleri is intended for adults aged 50 and older, and is meant to be used in addition to the mammograms, colonoscopies and other screenings that guidelines already recommend, not in place of them. The test looks for cancer-specific patterns that many types of cancer share and that show up in the blood before symptoms appear, and it predicts where in the body a detected signal is likely coming from. ## The Panel Split 6 to 4 on Whether the Test Works The 10 voting members agreed unanimously that Galleri is safe. On whether it is effective, they split 6 to 4. Much of that debate comes from the NHS-Galleri trial in England, which enrolled nearly 140,000 people. The trial [missed its main goal](https://www.sciencemediacentre.org/expert-reaction-to-press-release-from-grail-on-full-results-of-the-nhs-galleri-trial-being-presented-at-asco/), showing no statistically significant reduction over its three years in the combined stage III and IV cancer diagnoses that were its main measure, the late-stage cancers Galleri is meant to catch earlier. GRAIL reported a reduction in stage IV diagnoses in later screening rounds and frames that as a substantial result. Richard Houlston, an independent oncology professor, said the failure to meet the primary endpoint "is the crux of the issue here." ## GRAIL Says the Test Finds Several Times More Cancers Than Screening Alone GRAIL says that in its clinical studies Galleri detected "approximately four to seven times more cancers compared to standard of care alone," with most found at earlier stages and a low false-positive rate. Two large studies, PATHFINDER 2 in North America and the NHS-Galleri trial in England, showed increases in that range, roughly a 6.5-fold jump in PATHFINDER 2 and about 4-fold in the NHS trial. Josh Ofman, GRAIL's chief executive, said the vote "reinforces the strength of Galleri's clinical evidence." Ofman said the test was "developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening." GRAIL submitted its premarket approval application on January 29, 2026, and the FDA designated Galleri a Breakthrough Device in 2018. ## A Positive Result Does Not Always Mean Cancer In PATHFINDER 2, the test's [positive predictive value was about 60 percent](https://news.ohsu.edu/2026/09/22/pathfinder-2-findings-advance-multi-cancer-early-detection-blood-testing). In plain terms, roughly 4 in 10 people who got a positive "cancer signal" turned out not to have cancer, and a positive result still leads to follow-up testing to confirm or rule out disease. No multi-cancer early detection test has yet been shown to reduce cancer deaths, and researchers in the field consider that the central thing still to be proven. ## The Test Costs About $949 and Medicare Does Not Cover It GRAIL lists Galleri at about $949, or around $799 out of pocket. Medicare does not currently cover it. Under a 2026 law, the Nancy Gardner Sewell Act, Medicare will cover an FDA-approved multi-cancer test from 2028, but Galleri does not yet have that approval. ## FAQ **Q: Is the Galleri test FDA approved yet?** Not yet. The advisory panel only recommends; the FDA itself decides whether to approve Galleri, and it can approve it, decline, or ask for more data. That decision is still pending. **Q: What cancers can the Galleri test detect?** GRAIL describes it as a single test that looks for signals shared across many types of cancer, including some that have no recommended screening today, and it estimates where in the body a detected signal is coming from. **Q: Does the Galleri test replace mammograms and colonoscopies?** No. You would keep your usual screenings. Galleri is meant to look for cancers those tests do not check for, which is why it is used alongside them rather than instead of them. **Q: How much does the Galleri test cost and does insurance cover it?** GRAIL lists it at about $949, roughly $799 out of pocket, and most people pay for it themselves for now. TRICARE covers it once in a lifetime for eligible members aged 50 and older at higher risk, and Medicare is set to cover an approved multi-cancer test from 2028. **Q: What happens if the test finds a cancer signal?** A positive result is not a diagnosis. In PATHFINDER 2, about 4 in 10 people with a positive signal did not have cancer. Because the test estimates where the signal is coming from, that steer guides which follow-up scans or tests come next. **Q: Who can get the Galleri test?** It is intended for adults aged 50 and older who do not have a known cancer and want to look beyond standard screening. That age group carries a higher risk for many cancers. More on the Galleri test is at [galleri.com](https://www.galleri.com).