A Grail Cancer Test for the FDA
The multi-cancer blood test is proven to increase early detection that can save lives.
Sept. 20, 2026 4:58 pm ET
A Grail Cancer Test for the FDA – WSJ
The Galleri Grail Multi-Cancer Test is a test that detects cancer DNA fragments that float in the blood after cancer cells die. The article reports that the test failed to meet endpoints in the clinical trial published in February. This is an important issue because its failure shows what a success it was. Patients had their cancers detected in earlier stages then the control group. Survival rates are much higher when cancer is detected prior to stage 4, which this trial clearly showed.
Furthermore, when the Galleri Multi-Cancer Test is used yearly, the detection accuracy rates only increase dramatically. While survival did not improve, I don’t think the trial lasted long enough to show expected survival benefits. If the trial had gone on for 10 years, I think the results would be dramatic – even more so than was seen in the published trial. What the FDA needs to consider is that clinicians can detect cancers far earlier when the Galleri Multi-Cancer Test is used, and to be honest, this should now be standard of care. At Everwell Internal medicine, it is this standard of care that I recommend to my patients. I plan to use it yearly for myself and I recommend that my patients at an age that increases cancer risk (50+) get them as well.
Personally, I hope the FDA approves and implements use of this test as part of yearly covered screening – much as mammograms or colonoscopy – however, my prediction is that they will ignore the benefits due to the cost the government would incur when Medicare would then have to cover it. Until that day comes, I will remain hopeful and will continue making the Galleri Test part of my recommended screening tests. Of note, MDVIP patients get the test for $749, where the test is $949 for everyone else.
David Rosenstein, MD.