FDA Panel Recommends Approval Of GRAIL's Galleri Multi-Cancer Early Detection Test
(RTTNews) - GRAIL Inc.'s (GRAL) Galleri multi-cancer early detection test has received a favorable vote from the FDA panel, making it one step closer to approval.
Galleri is a multi-cancer early detection (MCED) blood test designed to detect cancer before symptoms appear, including cancers for which no recommended screening tests currently exist. It is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings. The test works by detecting DNA fragments released by tumor cells into the bloodstream and analyzing their methylation patterns to identify a cancer signal and determine where in the body it may have originated.
The 10-member Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee of the FDA voted on three questions concerning Galleri's safety, effectiveness and overall benefit-risk profile for screening adults aged 50 years and older for the early detection of multiple types of cancer.
On safety, the Committee voted unanimously in support of Galleri, while six members voted in favor of its effectiveness and four against. On the overall benefit-risk profile, seven members voted that the benefits of Galleri outweigh its risks, two voted against, and one abstained.
According to the company, Galleri is the only multi-cancer early detection (MCED) test supported by large interventional and randomized controlled studies in intended-use populations, including FDA-authorized Investigational Device Exemption (IDE) studies such as PATHFINDER 2 in North America and the landmark NHS-Galleri trial in England.
Across clinical studies, Galleri has detected approximately four to seven times more cancers than standard screening alone, with most of the cancers identified at earlier stages, when treatment with curative intent may be possible. This has been achieved while maintaining a low false-positive rate and high accuracy in predicting the cancer's signal origin, the company noted.
Commenting on the panel's recommendation, Josh Ofman, CEO of GRAIL, said, "Today's vote reinforces the strength of Galleri's clinical evidence. We believe the panel's recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test".
Launched as a laboratory-developed test in the U.S. in mid-2021, GRAIL has sold over 595,000 commercial Galleri tests through June 30, 2026. Galleri has been primarily sold through primary care physicians, health systems, employers, digital health platforms, payors, and life insurance providers.
GRAIL generates a significant portion of its revenue from screening revenue through Galleri sales, primarily in the United States. In the second quarter ended June 30, 2026, screening revenue rose to $42.6 million from $34.3 million a year earlier.
Although Galleri is already commercially available, FDA approval would give the test formal regulatory authorization and could pave the way for broader adoption among healthcare providers, payors and other healthcare channels.
The FDA's final decision on Galleri is expected in the coming months. The U. S. regulator usually follows the recommendations of its panels, although it is not mandatory to do so.
When we featured GRAIL on our site on September 26, 2025, the stock was trading around $48. It subsequently surged to a 52-week high of $118.84 on January 22, 2026. When we revisited the stock on August 12, 2026, it had retraced to $73.
Trading in the stock was halted Wednesday (Sep.23, 2026) ahead of the FDA panel vote. The stock had closed Tuesday at $108.52.
