FDA Panel Backs GRAIL's Galleri Multi-Cancer Blood Test

An advisory committee to the U.S. Food and Drug Administration voted on September 23, 2026 in favor of GRAIL's Galleri blood test, which is designed to detect signals of up to 50 forms of cancer, marking the first time a multi-cancer early detection test has reached this stage of FDA review.¹⁴⁵

The vote

The ten-member Medical Devices Advisory Committee unanimously found that Galleri is safe. Members then voted 6-4 that the test is effective, and 7-2, with one abstention, that its benefits outweigh its risks.²⁴⁵⁶

The FDA does not have to follow the recommendations of its advisory panels, though it often does. A final decision on GRAIL's premarket approval application is expected in the coming months, with GuruFocus reporting that the FDA is expected to rule in 2027.¹²³⁵

The committee also recommended that Galleri's marketing materials include explicit guidance for patients to continue routine, guideline-recommended cancer screenings rather than substitute them with the blood test.¹

Clinical evidence reviewed

Two large studies informed the panel's review: NHS-Galleri, which followed over 140,000 people within England's National Health Service, and PATHFINDER 2, a North American study that signed up upwards of 35,000 participants older than 50. In PATHFINDER 2, Galleri detected cancer signals in 287 people, of whom about 60 percent were later diagnosed with cancer, and the test correctly predicted the likely site of origin in roughly 91 percent of confirmed cases.¹²⁴

According to GRAIL, Galleri detected roughly four to seven times more cancers than standard screening alone in its clinical studies, and adding the test to recommended breast, colorectal, cervical and lung screenings raised detection 6.5-fold, with 71 percent of newly found cancers identified at stages I through III. GRAIL also reported that the NHS trial found stage IV cases of 12 designated cancers dropped 22 percent by the second screening round and 26 percent by the third.⁴⁵⁶

However, according to NPR, the two trials often failed to detect many cancers, particularly early-stage disease, and neither showed an overall reduction in mortality or met its primary endpoint; the NHS trial did not show a reduction in the combined stage III/IV endpoint. MD+DI reported that critics noted the test misses 85 percent of stage 1 cancers.¹⁴⁸

Voices of caution

Phil Castle, who leads the National Cancer Institute's cancer prevention division, told the panel that Galleri's performance data remain too early-stage to prove real clinical benefit. He said, "Routine approval and broad population rollout would risk harm and waste resources."¹

Michelle Tarver, who directs the FDA's Center for Devices and Radiological Health, expressed guarded approval, remarking that "the concept of a blood based multi-cancer detection test like the one being discussed today represents a genuinely promising opportunity," but cautioned that "technologies with this kind of reach and novelty demand careful, rigorous evaluation."¹

Cancer researcher Ajay Goel of City of Hope called the vote "an important step forward for the field" but said he would view it as "an encouraging step rather than the final word on the clinical value of this type of testing," noting that longer-term evidence on advanced cancers and deaths is still needed. Colin Pritchard of the University of Washington said more research is needed on which populations should receive the test and how to handle follow-up after a positive result.²

Company and market response

GRAIL's CEO Josh Ofman remarked, "Today's vote reinforces the strength of Galleri's clinical evidence." He continued, "We believe the panel's recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test," and said the firm remains "committed to working with the FDA as it completes its review of Galleri, the first PMA submission for a multi-cancer early detection test." Ofman also pointed out that over 200 doctors, nurses, professional groups, patients and advocates had voiced support for the test.⁵⁶

GRAIL stock surged 33 percent after the FDA posted favorable review documents, and shares reached a 52-week high following the committee's vote. Galleri is already available by prescription as a laboratory-based diagnostic priced at $949, and full FDA approval is expected to support insurance and Medicare reimbursement, after Congress approved Medicare coverage for FDA-approved multi-cancer detection tests.¹³⁷