A panel of outside experts advising the US Food and Drug Administration voted on September 23, 2026 in favor of Galleri. The blood test, made by the company Grail, looks for signs of many different cancers in adults aged 50 and older1. The panel’s 10 voting members held three separate votes. All 10 agreed the test is safe. They voted 6 to 4 that it is effective, and 7 to 2, with one abstention, that its benefits outweigh its risks2.
This was the first time an FDA advisory committee had reviewed a full approval application for a test that screens for many cancers at once1. The vote is advice, not a decision. The FDA is not bound by it, and a final ruling is expected in the coming months3. Pauline Funchain, a Stanford oncologist, told a local TV station that the agency rarely goes against its panels: “Typically they will go with the votes”4.
What the test does
Dying cancer cells release small pieces of DNA into the blood. That DNA carries chemical tags, a pattern called methylation, that differ from normal DNA5. Galleri reads these patterns from a blood sample using DNA sequencing. If it finds a cancer signal, it also predicts which part of the body the signal probably came from, so doctors know where to look next2.
Sources give slightly different counts of what it covers. Grail describes Galleri as designed to screen for more than 50 types of cancer4. NPR reported the company’s claim as “up to 50”6. The request before the FDA is for a prescription screening test for adults 50 and older2. It would be used once a year5, on top of usual screenings such as colonoscopies and mammograms, not in place of them6. The test has been sold privately with a prescription since 20217.
The appeal is clear. More than half (58%) of US cancer deaths come from cancers that have no recommended screening test, such as pancreatic and liver cancer7.
The evidence the panel weighed
The panel reviewed two large studies run by Grail6.
- NHS-Galleri, in England, enrolled about 142,000 adults aged 50 to 77. They were randomly split into a group whose blood was screened with Galleri once a year for three years and a group whose blood was drawn and stored7.
- PATHFINDER 2 tested about 35,000 US adults aged 50 and older once and followed them for a year. It had no comparison group7. That means it can show how accurate the test is, but not whether it improved people’s health7.
In the analyses shown to the panel, the test rarely flagged cancer in people who did not have it. The false-positive rate was 0.15% in PATHFINDER 2 and 0.26% in NHS-Galleri2. When the test did flag a signal, cancer was confirmed in 77% of cases in PATHFINDER 2 and 66% in NHS-Galleri2.
The bigger issue was missed cancers. Among people diagnosed with cancer within 12 months, Galleri had flagged 35% in PATHFINDER 2 and 31.6% in NHS-Galleri2. These figures come from retesting stored blood with the current version of the test. Both studies had originally used an earlier version2. Epidemiologist Jenn Dowd, working from the published studies, put it this way: in NHS-Galleri the test missed two-thirds of cancers diagnosed within a year. In PATHFINDER 2 it found 173 of 440 cancers, and about 6 in 10 positive results turned out to be cancer7. The numbers differ somewhat between sources because they come from different analyses.
How well it worked depended on the cancer. In NHS-Galleri, it caught 63.8% of lung cancers and 53.3% of bowel cancers, but only 19.1% of breast cancers and 10.7% of prostate cancers. Among cancers with no standard screening, it caught 80% of liver cancers, 75% of ovarian or fallopian tube cancers and 65.4% of esophageal cancers2. It was also much better at finding advanced cancers than early ones. It caught 13.6% of stage I cancers and 60% of stage IV2.
Grail says that across its studies, adding Galleri found about four to seven times more cancers than standard screening alone, with most found at earlier stages3. In PATHFINDER 2, adding Galleri increased cancer detection 6.5-fold8.
What it does not show yet
Finding a cancer is not the same as saving a life. A screening test might pick up a cancer that would soon have been found anyway, or a slow-growing one that would never have caused harm7. That is why screening tests are usually expected to prove they improve outcomes7.
NHS-Galleri did not meet its main goal, which was fewer late-stage (stage III and IV) cancers in the screened group7. The screened group did have fewer stage IV cancers and more stage III over three years7. Data on cancer deaths from the trial has not been reported yet7.
A positive result also leads to more testing. In PATHFINDER 2, 159 of 218 people with a cancer signal (72.9%) had at least one invasive procedure, such as a biopsy or a scope. That included 47.8% of those who turned out not to have cancer2. Nine people had 10 side effects during these follow-up tests2.
What panelists and officials said
The split votes showed real doubt. Stanley Lipkowitz of the National Cancer Institute voted no on effectiveness4:
“It’s a transformative test, but that unfortunately means that we really need to be more critical before we approve it.”
Kelly Hunt of MD Anderson Cancer Center said she believed the test is safe “as an adjunct to age-appropriate cancer screening”4. Phil Castle, who directs the National Cancer Institute’s Division of Cancer Prevention, spoke to the panel before the vote. He warned that the test could give people a false sense of security and said: “Routine approval and broad population rollout would risk harm and waste resources”6. One panel member changed his vote twice during the meeting, according to a McGill University science writer9.
The panel recommended that Galleri’s marketing tell people to continue routine cancer screenings and avoid calling it an “early” detection tool6. Michelle Tarver, who heads the FDA’s device center, said the idea “represents a genuinely promising opportunity,” but that such technologies “demand careful, rigorous evaluation”6. More than 200 physicians, nurses, patients, advocates and others sent written or spoken support for approval1.
Who is behind it
Grail is based in Sunnyvale, California4. Both main studies were run by the company6. Its CEO, Josh Ofman, said after the vote: “Today’s vote reinforces the strength of Galleri’s clinical evidence”3. The FDA gave Galleri “Breakthrough Device” status in 2018, which speeds up review, and Grail filed its approval application on January 29, 20263.
There is money at stake. FDA approval could open the door to insurance payment6. Congress has passed a law allowing Medicare to cover FDA-approved multi-cancer tests, possibly as soon as 20287. Some estimates floated for covering the test through Medicare run to US$55 billion9.
How it fits the field
Hundreds of companies are working on blood tests to detect cancer. None that screens for many cancers has yet won FDA approval6. Because Galleri is furthest along, it is seen as a test case for the whole industry6. A competing test from Exact Sciences, since bought by Abbott, is also seeking FDA approval6. “If the FDA approves it, it validates the overall concept,” said Cristian Tomasetti of City of Hope, who helped develop the technology behind that rival test but is no longer involved with the company6.
What to watch next
- The FDA’s final decision, expected within months10. One outlet noted that an approval with conditions, such as required follow-up studies, would shape how widely the test is used and how insurers respond8.
- Whether the FDA requires the marketing warnings the panel recommended6.
- Cancer death data from NHS-Galleri, which has not been reported yet7.
- Medicare and insurer coverage decisions, which depend on approval7.
