This test screens for 50 cancers - but whether Medicare and other health insurers will cover it hinges on FDA approval

An earlier version of this article incorrectly stated Roberto Veronese's position at Grail. He was a consultant. By Jaimy Lee

A group of FDA advisors said Wednesday that the benefits of the Galleri test outweigh its risks

Grail sells the Galleri test, which screens for 50 types of cancer using a blood draw.

A group of advisers to the Food and Drug Administration is largely in favor of approving a cancer-detection test popular in longevity circles, a crucial step in Grail's bid to secure insurance coverage of the Galleri test.

Galleri is a multicancer detection test developed by Grail (GRAL), a publicly traded spinoff from sequencing giant Illumina (ILMN). It's marketed directly to Americans who are at least 50 years old on platforms like Function Health and Hims & Health Health (HIMS) for $949 in cash.

But some doctors are skeptical that the test can do what it promises, particularly after Galleri failed to meet the primary endpoint - reducing later-stage diagnoses of 12 cancers - in a major study conducted with England's National Health Service. In the randomized trial, about 145,000 people without an elevated risk of cancer received the test three times in addition to traditional cancer screening, but researchers didn't see a statistically significant difference in the detection of stage 3 and 4 cancers. When Grail announced those results in February, its stock lost half its value in a single day.

"There is no evidence that any multicancer detection testing prevents cancer, consistently detects it at an earlier stage, or reduces cancer-associated mortality," two researchers wrote in the Lancet this week. "The widespread, sanctioned introduction of multicancer detection tests for the average-risk population continues to be driven predominantly by hope, not by evidence."

'We must not lower the bar for approvals'

During Wednesday's meeting of the FDA advisory committee, advisors raised other questions. Phil Castle, an oncologist who is about to be named associate director of the National Cancer Institute, said that multicancer detection tests, while promising, need more evidence. He also suggested dropping the "early" cancer descriptor.

"Nobody wants an MCD test on the market more than me, except perhaps those that stand to gain a profit," Castle said. "However, until such time, we must not lower the bar for approvals and introduction into the population, regardless of how desperate we are for solutions."

Galleri and other multicancer detection tests sold by Caris Life Sciences (CAI) and Abbott (ABT) have captured the attention of health-focused Americans. Caris launched its test earlier this year, and Guardant Health (GH) is working on one. Galleri's U.S. sales soared 26% last year, jumping to $136.8 million.

"The typical early customer was an affluent early adopter already investing in their health, and very often someone who had lost a parent, a spouse or a friend to a cancer found too late and did not want to be blindsided," said Roberto Veronese, a former Grail consultant who now runs an advisory firm for diagnostics companies. "The numbers confirm the demand is real."

Michael Botta, the co-founder of Sesame Care, an online marketplace that connects patients directly with medical services for cash prices, is one of those customers. After his second child was born, he took a hard look at his health. He went on a statin, started taking a blood-pressure medication, and ordered a Galleri test.

"If there's any useful signal that I can get from a test like this, well, I'd rather have it than not have it," Botta said.

The test is a snapshot, not an indicator of lifetime risk or a confirmation that someone is cancer-free. It works by examining cell-free DNA in a patient's blood to find "signals" associated with 50 types of cancer. The theory is that it can detect cancers earlier, allowing patients to start treatment earlier, while also looking for cancers the medical system doesn't regularly screen for, like pancreatic cancer. It's not being pitched as a replacement for common cancer-screening methods, like mammograms for breast cancer or PSA blood tests for prostate cancer. If a patient gets a positive test, they are instructed to undergo a cancer work-up, whether that's imaging or biopsies.

The multicancer detection tests are part of a new wave of popular preventive health interventions like whole-body scans that seek to allow people to better understand their health. However, there are still questions about the accuracy and benefits of these tools, particularly since they are paid for in cash. Some employers like Salesforce (CRM) offer the test as a benefit to workers.

"This is a pivotal moment, a potential paradigm shift from screening for individual cancers one at a time to also being able to screen individuals for the multitude of cancers that we are all at risk of developing," said Eric Sue, an internal-medicine physician in Los Angeles, during Wednesday's meeting. "That is the promise of multicancer early detection - find more cancers, find them earlier and deny cancer what it needs most to become deadly."

How the FDA advisors voted

The FDA advisors voted 6-4 that the test is effective and 7-2 (with one absention) that Galleri's benefits outweigh the risks. The committee's members voted unanimously in favor of the test's safety.

The FDA usually considers the opinions of its advisers before deciding whether to approve a product like the Galleri test but is not required to do so. The regulator's final decision is expected in the first quarter of next year.

Though Grail's laboratory-developed test is sold legally in the U.S., most health insurers, including Medicare, won't cover it without premarket approval from the FDA. A provision tucked inside this year's federal spending package allows Medicare coverage of one multicancer early-detection test per year starting in 2028 if the test is FDA-approved.

"A positive vote would meaningfully de-risk the [multicancer early detection] category and provide a favorable readthrough" for Caris and Guardant Health, Jefferies analyst Tycho Peterson told investors in advance of the meeting.

Grail's stock closed 33.7% higher on Monday after the FDA published documents that didn't raise any significant questions about the test. Its shares are up 22.1% since the start of the year.

-Jaimy Lee

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09-23-26 1759ET

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