FDA Advisory Panel Votes in Favor of the Galleri Test: What It Means for You
Key facts at a glance
- On September 23, 2026, an FDA advisory panel voted in favor of GRAIL’s Galleri® multi-cancer early detection blood test for adults aged 50 and older.
- The vote: unanimous on safety, 6 to 4 on effectiveness, and 7 to 2 (one abstention) that benefits outweigh risks.
- Galleri is not yet FDA approved. The FDA’s final decision is expected in the coming months.
- In the FDA’s review of the PATHFINDER 2 study, Galleri had 99.85% specificity and a 77% positive predictive value.
- A negative result does not rule out cancer. Galleri is meant to be added to, not replace, recommended screenings.
- In Arizona, Amsara Health offers Galleri with provider guidance before and after the result.
On September 23, 2026, an FDA advisory panel voted in favor of GRAIL’s Galleri® multi-cancer early detection blood test. It is the first multi-cancer early detection test to reach this stage, and the most significant regulatory milestone yet for a test that screens for dozens of cancers from a single blood draw. Here is what the panel decided, what it does not mean yet, and what it changes for you if you live in Arizona.
How did the FDA advisory panel vote on Galleri?
The Molecular and Clinical Genetics Devices Panel of the FDA’s Medical Devices Advisory Committee reviewed GRAIL’s premarket approval application, submitted on January 29, 2026. The proposed use is screening adults aged 50 and older for multiple cancers, in addition to guideline-recommended screenings. Ten voting members answered three questions:
- Safety: unanimous support.
- Effectiveness: 6 votes to 4 in favor.
- Benefit versus risk: 7 votes to 2, with one abstention, that the benefits outweigh the risks.
Galleri has held the FDA’s Breakthrough Device designation since 2018, a status reserved for technologies that may offer more effective diagnosis of life-threatening diseases.
Is Galleri FDA approved now?
Not yet. Advisory panels advise; the FDA makes the final decision, which GRAIL expects in the coming months. Until then, Galleri continues to be offered as a laboratory-developed test run in GRAIL’s CLIA-certified laboratory. That is the same legal pathway under which licensed clinicians order it today, including at Amsara Health.
Approval also matters for coverage. The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, signed into law in February 2026, allows Medicare to cover tests like Galleri once they are FDA approved and have shown clinical benefit. Approval is the first gate; coverage does not follow automatically.
How accurate is the Galleri test, according to the FDA?
The FDA’s briefing document for the panel reviewed two large studies. We use the FDA’s figures here because they are the independent analysis the panel voted on.
- PATHFINDER 2 (United States, 22,698 participants with 12 months of follow-up): specificity of 99.85%, fewer than two false alarms per 1,000 people without cancer. When Galleri flagged a cancer signal, it was right 77% of the time (positive predictive value), and it identified the correct organ system 94.3% of the time.
- NHS-Galleri (England, 142,250 randomized participants): specificity of 99.74%, positive predictive value of 66.2%, and 91.9% accuracy in locating the cancer’s origin.
Why was the effectiveness vote closer?
The 6-to-4 split reflects real open questions, and you deserve to hear them plainly. According to the FDA, Galleri detected 35.0% of the cancers diagnosed within a year in PATHFINDER 2 and 31.6% in NHS-Galleri, and about one in four (24.9%) stage I and II cancers. A negative result is reassuring, but it does not rule out cancer. Whether multi-cancer screening reduces deaths over the long term is still being studied.
That is why Galleri is designed to add to, not replace, your mammogram, colonoscopy, cervical screening, and lung screening where recommended. Our full guide explains what the Galleri test can and cannot tell you.
What does the FDA panel vote mean for you?
- If you are 50 or older, or have a personal or family history that raises your risk, the evidence behind Galleri has now received an important independent review.
- Keep every guideline-recommended screening on schedule. Galleri works best as an extra layer, not a substitute.
- Have your result interpreted by a clinician who knows the test. At Amsara Health, Dr. Mia Chorney and Dr. Tamara Djurisic have completed GRAIL’s Galleri education for ordering clinicians.
- Ask how Galleri fits alongside other longevity diagnostics, such as functional genomics and biological age testing.
Our founder, Susan Sly, wrote about her own decision in I Have a Lot of Life to Live. That Is Why I Ordered the Galleri Test.
Where can I get the Galleri test in Arizona?
Amsara Health, a concierge integrative telehealth practice based in Scottsdale, offers the Galleri test to adults across Arizona. Your blood is drawn at Sonora Quest, and a provider meets with you before and after your result. Through October 31, 2026, Galleri is on sale for $1,000 for non-members and $800 for members (regularly $1,500 and $1,200). See the Tests & Pricing page for what is included, or compare membership options.
Frequently asked questions
Did the FDA approve the Galleri test?
Not yet. On September 23, 2026, an FDA advisory panel voted in favor of approving Galleri for adults 50 and older. The FDA makes the final decision, which is expected in the coming months. Until then, Galleri is available as a laboratory-developed test ordered by a licensed clinician.
How did the FDA advisory panel vote on Galleri?
The ten voting members of the FDA Molecular and Clinical Genetics Devices Panel voted unanimously that Galleri is safe, 6 to 4 that it is effective, and 7 to 2 with one abstention that its benefits outweigh its risks for adults 50 and older.
How accurate is the Galleri test according to the FDA?
In the FDA briefing on the PATHFINDER 2 study, Galleri had 99.85% specificity, a 77% positive predictive value, and 94.3% accuracy in identifying where a cancer started. It detected 35% of cancers diagnosed within a year, so a negative result does not rule out cancer.
Does the Galleri test replace a mammogram or colonoscopy?
No. Galleri is designed to be used in addition to guideline-recommended screenings such as mammograms, colonoscopies, cervical screening, and lung screening, not instead of them.
Who should consider the Galleri test?
The proposed FDA indication is adults aged 50 and older. People with a personal or family history that raises cancer risk may also benefit. A provider can help you decide whether Galleri fits your plan.
Where can I get the Galleri test in Arizona?
Amsara Health, a concierge integrative telehealth practice based in Scottsdale, offers Galleri to adults across Arizona, with the blood draw at Sonora Quest and provider visits before and after the result. Through October 31, 2026, the price is $1,000 for non-members and $800 for members.
Sources
- U.S. Food and Drug Administration. Executive Summary for the September 23, 2026 Molecular and Clinical Genetics Panel meeting (Galleri).
- U.S. Food and Drug Administration. September 23, 2026 Molecular and Clinical Genetics Panel meeting page.
- GRAIL. FDA Advisory Committee Votes in Favor of Approval of GRAIL’s Galleri Multi-Cancer Early Detection Test. September 23, 2026.
- U.S. Congress. Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 842).
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