An FDA panel backed the first multi-cancer blood test. Here's what the data actually show.

On September 23, 2026, the FDA's Molecular and Clinical Genetics Devices Panel reviewed GRAIL's premarket approval application for Galleri, a blood test that looks for cancer-specific methylation patterns in cell-free DNA. The panel voted 7–2, with one abstention, that its benefits outweigh its risks; it supported safety unanimously and effectiveness 6–4, according to GRAIL.

If the FDA approves it, Galleri would be the first authorized test for screening for multiple types of cancer at once. The FDA's executive summary for the meeting states plainly that "there are currently no FDA-authorized devices indicated for the screening for multiple types of cancer."

What the test is for

As proposed, Galleri is intended to screen adults aged 50 or older for the early detection of multiple cancer types. A positive result ("Cancer Signal Detected") comes with a prediction of where in the body the signal likely originates. A negative result does not rule out cancer, and people are meant to keep up with recommended single-cancer screening such as colonoscopy and mammography.

What the numbers say

The FDA's briefing reports results from two pivotal studies. In PATHFINDER 2, with 12 months of follow-up:

• Sensitivity: 35.0% of cancers diagnosed within 12 months were flagged by the test (95% CI 29.8–40.5%).
• Specificity: 99.85%. The false-positive rate was 0.15%.
• Positive predictive value: 77.0%. About three in four people with a positive result were diagnosed with cancer within a year.
• Number needed to screen: 202 people tested per cancer detected.
• Where it came from: when the test was right, it predicted the cancer's origin correctly 94.3% of the time.

In the UK's NHS-Galleri trial, performance was similar: 31.6% sensitivity, 99.74% specificity and a 66.2% positive predictive value.

The early-stage question

The point of screening is to catch cancer early, when it's most treatable. PATHFINDER 2 found 21.4% of stage I cancers, 33.3% of stage II and 58.1% of stage III. The FDA asked the panel to weigh performance separately for cancers that already have recommended screening (breast, colorectal, lung, cervical, prostate) and those that don't — where a blood test could fill a real gap.

What happens next

The FDA is expected to decide on the application in the coming months, GRAIL says. Advisory votes are recommendations; the agency makes the final call. The test was granted Breakthrough Device designation in 2018, per the FDA briefing.

For Texas, where companies like Austin-based cell-free DNA lab operator Natera and San Antonio's bioAffinity Technologies work on molecular and early-detection diagnostics, the decision will help set expectations for how the FDA judges screening tests that look for many diseases at once.