Major Cancer Product Fails
On February 12th, 2026, Grail, the maker of a promising blood test to detect early cancer and save more lives, announced that its test failed.
Galleri has been sold in the United States since 2021 and costs $949. Although the blood test has not been approved by the Food and Drug Administration, the company sells it through a regulatory loophole that allows certain tests to be marketed without review. Few insurance companies cover the test, so most people pay for it themselves. Grail reported that it has sold nearly 500,000 tests so far, including over 185,000 last year.
The Galleri blood test has been trialled on 142,000 NHS patients in the UK with the goal of finding cancers early and saving lives. However, Grail said there were still positive signs in the data that some of the most aggressive cancers could be prevented. But researchers said any benefits of the test “remain speculative” until it is proven to save lives, and the NHS said it was looking at the results “carefully”. However, even with the announced future research into this, Grail’s stock was down 50 percent on Feb. 13th, mainly because nearly all of the company’s revenue comes from sales of the Galleri test.
In the trial, the goal of using the blood test was to improve the detection of more than 50 cancers at Stages 1 or 2, with the set target of a 20% reduction in Stage 3 and 4 cancer diagnoses compared to other forms of screening. Although the trial missed that target across all cancers, it found that for a subset of 12 cancer types, which slightly helps support usage for identifying specific types of cancers. Stage 3 and 4 cancer diagnoses decreased. That might suggest earlier detection of tumors.
Bob Ragusa, Grail’s CEO, states, “We are excited to see the substantial reduction in Stage IV cancer diagnoses, as well as the continuing strong Galleri test performance metrics…Based on these promising data, as well as the exciting PATHFINDER 2 results, we are expanding our field-based sales and medical teams to bolster our education efforts and support growing demand.”
However, the American Cancer Society still stresses that these tests need to be studied further before being recommended for public use. They state that even with approval, they do not replace current screening tests, such as mammograms, Pap tests, and HPV tests, for detecting many forms of cancer.
Sources:
https://www.sfgate.com/bayarea/article/grail-cancer-test-21887554.php