---
title: An FDA Panel Votes in September on a Blood Test That Screens for Many Cancers at Once
description: An FDA advisory panel votes on 23 September on Galleri, a blood test that screens for many cancers at once. Comments sent by 8 September reach the committee.
author: Dr Marina Nani (Editor-in-Chief)
updated: 2026-08-08T19:24:03.993Z
canonical: https://richhealthmagazine.com/article/fda-panel-galleri-multi-cancer-blood-test-vote
image: https://cdn.nanimediahouse.com/galleri-blood-test-laboratory-118886.webp
categories: Longevity & Science
content_type: News
region: United States
publication: Rich Health Magazine
schema_type: Article
---

A blood test meant to catch many cancers at once, rather than one at a time, goes in front of an outside expert panel next month. The Food and Drug Administration's Molecular and Clinical Genetics Panel meets on 23 September, from 9 a.m. to 6 p.m. Eastern time, to [discuss and vote on the premarket approval application](https://www.federalregister.gov/documents/2026/08/10/2026-16245/molecular-and-clinical-genetics-panel-of-the-medical-devices-advisory-committee-notice-of-meeting) for Galleri, the test made by GRAIL. The meeting is open to the public, at the FDA's White Oak campus in Silver Spring, Maryland, and it streams online.

GRAIL submitted the application on 29 January 2026. The FDA designated Galleri a Breakthrough Device in 2018.

## The Proposed Use Covers Adults Aged 50 and Older, Alongside Existing Screening

The application describes Galleri as a test that looks for cancer-specific patterns on cell-free DNA, the fragments of genetic material that circulate in the blood, taken from a single blood sample. The proposed indications would offer it to adults aged 50 or older to screen for several types of cancer at once, run in addition to the single-cancer screenings already recommended for a person's age and risk, not instead of them. If it returns a "Cancer Signal Detected" result, it also predicts where in the body that signal came from, and the proposed wording says such a result should lead to a diagnostic workup arranged by a qualified health professional. A "No Cancer Signal Detected" result does not rule out cancer, and a person who gets one should carry on with their usual recommended screening. The test would run only in GRAIL's own laboratory and would need a prescription.

## Three Years of Screening Cut the Number of Cancers Found at Stage IV

The strongest evidence in front of the panel comes from the NHS-Galleri trial, the first randomised controlled trial of a multi-cancer early detection test. Three years of screening cut the number of cancers found at stage IV, and the screened group had 21 percent fewer cancers picked up because someone had developed symptoms and 20 percent fewer found in an emergency setting, where cancer tends to be further along and harder to treat. The trial did not reach its predefined primary endpoint, which was reducing the number of cancers found at stage III or IV together. [Specificity was 99.55 percent and positive predictive value was 52 percent](https://www.asco.org/about-asco/press-center/galleri-early-detection-shift-timing-cancer-detection), meaning just over half of positive results turned out to be cancer, and sensitivity and negative predictive value were not reported. When the test did find cancer, its prediction of where that cancer started was right in 87 percent of cases where it named one site and 92.5 percent where it named two. No participant had a serious side effect from the blood draw, though some had minor bruising.

The American Society of Clinical Oncology, which summarised the results, described the mixed picture this way: "While the Galleri-NHS study results show some encouraging trends toward tumor downstaging, it is important to recognize that the trial did not statistically reduce late-stage cancers by its predefined primary endpoint. Nevertheless, these findings still offer genuine hope for deadly malignancies that currently lack screening options, such as ovarian and pancreatic cancer." The society also flagged two questions the trial cannot yet answer: whether every extra cancer the test found would ever have caused symptoms, and whether finding them earlier helps people live longer.

> "These findings still offer genuine hope for deadly malignancies that currently lack screening options, such as ovarian and pancreatic cancer."
> — American Society of Clinical Oncology

## GRAIL's Own Study Reports Higher Detection in a Narrower Set of Cancers

GRAIL has published separate results from its own study, PATHFINDER 2. The company reports a positive predictive value of 61.6 percent and specificity of 99.6 percent, which it describes as a false positive rate of 0.4 percent. On sensitivity it reports two figures for two different groups: 73.7 percent for the twelve cancer types responsible for two-thirds of US cancer deaths, and 40.4 percent across all cancer types. GRAIL says 70 to 80 percent of US cancer deaths come from cancers that have no recommended screening test at all.

## Comments Sent by 8 September Reach the Committee

The FDA has opened a public docket, FDA-2026-N-8004, for written comment. Anything filed by 8 September is given to the committee before it meets. The docket stays open until 16 September, but comments after the 8th go to the FDA rather than to the panel. Members of the public can also apply to speak in a session set aside from roughly 1 p.m. to 2 p.m. on the day: the FDA needs to hear from anyone wanting a slot by 28 August and will confirm by 31 August, and if more people apply than there is time for, it may run a lottery. The agency intends to publish its own background review no later than two business days before the meeting.

## FAQ

**Q: Are any multi-cancer early detection tests approved by the FDA?**
GRAIL says this is the first premarket approval application for a test of this kind. The 23 September meeting is the advisory panel stage of that review, and the panel's role is to give the FDA advice and recommendations rather than to make the final decision.

**Q: How accurate is the Galleri test?**
The two studies report different measures, so their numbers are not interchangeable. The randomised NHS-Galleri trial reported specificity and positive predictive value but not sensitivity, while GRAIL's own PATHFINDER 2 study reported a higher positive predictive value and a sensitivity figure that changes sharply depending on which cancers are counted.

**Q: Can the public comment before the vote?**
Yes. Written comments to docket FDA-2026-N-8004 reach the committee if they arrive by 8 September. Anyone who wants to speak at the meeting must tell the FDA by 28 August.

**Q: What is cell-free DNA?**
Fragments of genetic material that cells shed into the bloodstream. Galleri looks for chemical patterns on those fragments that are characteristic of cancer.