The US Food and Drug Administration, FDA, will hold a special advisory meeting in September to review the company Grail's "Galleri" test, a blood test that aims to detect more than 50 types of cancer.
According to Reuters, the test is currently available in the US as a laboratory test, but has not yet been approved by the FDA. It is undergoing a premarket review, one of the most stringent forms of review for medical devices.
The “Gallery” works by searching the blood for molecular signals that may be associated with tumors. The company says the test uses artificial intelligence to analyze these signals and identify the possibility of cancer being present.
But the results so far have not been a simple success story. In a large study in the United Kingdom, the test failed to significantly improve early cancer detection overall. However, according to Reuters, it reduced stage IV diagnoses for 12 high-mortality cancers by 26% by the third round of screening.
The test is not intended to replace existing screenings, such as mammograms or colonoscopies, but to be used in addition to them. This is also one of the main points that the FDA is expected to review: how useful the test is in practice and how much it can really help in catching the disease earlier.
Grail submitted regulatory data in January 2026, including results from studies in the US and the UK. Following news of the FDA meeting, the company's shares rose by about 5%.
If approved, “Galleri” could open a new chapter in cancer diagnosis through blood tests. But for now, experts remain cautious: the promise is great, but the decision will depend on scientific evidence and how the test performs beyond the lab.
