Grail faces a tough road. Its Galleri blood test promises to spot signals from more than 50 cancers in a single draw. Yet the company’s pivotal NHS-Galleri trial missed its main goal. Investors sold off shares hard in February. Now fresh data from the American Society of Clinical Oncology meeting offers a more nuanced picture.
The randomized controlled trial enrolled 142,942 asymptomatic adults aged 50 to 77 in England. Participants received either annual Galleri screening for three years plus usual care or usual care alone. Primary endpoint? A statistically significant drop in combined stage III and IV diagnoses across 12 prespecified deadly cancers. It didn’t happen. Incidence rate ratio came in at 1.03. Cases landed at 706 in the intervention arm versus 688 in control.
But look closer. Secondary measures tell another story. The test cut stage IV diagnoses by 14 percent overall. That gap widened over time. By the third year of screening the reduction reached 26 percent for metastatic disease. Across all cancer types researchers counted 3,637 diagnoses in the Galleri group against 3,400 in control. Four times as many cancers turned up through screening rather than symptoms. And 21 percent fewer cancers surfaced via clinical presentation. Emergency department detections fell 20 percent.
These shifts matter. Stage IV cancers carry far worse odds. Earlier catches open doors to treatments with curative intent. For the 12 deadly cancers targeted in advance — including pancreas, ovary, esophagus, liver and lung — sensitivity hit 54.7 percent in one analysis from the NHS data. In the separate PATHFINDER 2 study of 35,900 North American adults that figure climbed to 69.8 percent. Positive predictive value registered 52 percent in the big UK trial and 60.3 percent in the U.S. one. Specificity stood at 99.55 percent.
The Motley Fool reported on these details June 21 noting the test moved closer to real-world use and what that could mean for Grail investors. https://www.fool.com/investing/2026/06/21/a-blood-test-that-screens-for-50-cancers-just-move
Grail’s CFO Aaron Freidin addressed follow-up data at a Goldman Sachs conference. “There are people in the control arm who have cancer that isn’t being found because it hasn’t presented clinically. So after another 12 months go by, more of those cancers will show up.” Management highlighted the favorable trend toward fewer late-stage cases in the prespecified deadly group. They also pointed to positive predictive value as a strength. Insurers weigh test cost against downstream diagnostics. Galleri’s figures compare favorably to mammography or Cologuard once that full picture comes into view.
Yet skepticism runs deep. The BMJ laid out the shortcomings in detail. The primary endpoint failure confirmed what many suspected. Richard Houlston, a professor of molecular genetics, called the low sensitivity for early-stage disease in prior data “strikingly low.” He warned of high false-positive burden that could overwhelm health systems. Even if the main goal had been met uncertainty would remain about population-level impact. Nitzan Rosenfeld echoed similar doubts. The test costs roughly $949. At scale that adds up fast.
STAT News ran an oncologist’s perspective days after ASCO. Sana Raoof noted the primary miss stemmed partly from a reduction in stage IV offset by an increase in stage III. Three years may simply prove too short. Longer follow-up akin to lung cancer screening trials could reveal clearer mortality benefits. Still she saw genuine hope. The test quadrupled screen-detected cancers. Positive predictive value of 52 percent beats many existing modalities. For cancers without routine checks — pancreatic, ovarian, liver — any reliable signal counts. “The trial demonstrates that annual multi-cancer early detection testing is feasible at scale,” said lead investigator Charles Swanton according to the ASCO press release.
ASCO itself struck a measured tone. Julie R. Gralow, ASCO’s chief medical officer, described the trends as encouraging but stressed the need for longer follow-up before incorporation into guidelines. The trial was funded by Grail. Site-of-origin prediction accuracy ranged from 87 to 92.5 percent. That helps direct next steps but isn’t perfect. False positives and the anxiety they trigger remain real concerns. So does the diagnostic odyssey some patients face after a positive result.
Grail submitted its premarket approval application to the FDA in January. The agency accepted it for review. That filing draws on PATHFINDER 2 performance and safety data plus the first round of NHS-Galleri results. A bridging study links the trial version to the one now under consideration. Q1 revenue grew 37 percent year-over-year to $39.8 million. Test volume jumped 50 percent past 56,000. The stock has been volatile. It dropped more than 30 percent earlier in the year on the initial topline miss but recovered some ground after ASCO presentations. Recent analyst moves include Goldman Sachs initiating coverage at neutral with a $60 target.
ecancer.org covered the ASCO findings in early June highlighting the 14 percent drop in stage IV cancers and 16 percent rise in early-stage diagnoses. The Guardian reported the trial’s failure to meet its main aim on May 30. Cancer Research UK maintains a page on the test and notes additional results continue to emerge.
The debate won’t end soon. Proponents argue the stage shift alone justifies further investment. Detecting more cancers before symptoms appear changes the conversation from palliation to cure for thousands. Critics counter that without proven survival gains or cost-effectiveness data at population scale the test risks becoming an expensive distraction. False positives could lead to unnecessary procedures. Overdiagnosis of indolent cancers poses another hazard.
PATHFINDER 2 added context. More than 70 percent of detected cancers in that study allowed treatment with curative intent. The test does not replace standard screenings. It supplements them. Galleri looks for methylation patterns in cell-free DNA. That shared signal across tumor types makes the broad net possible. Yet biology is messy. Not every signal leads to actionable disease within a useful window.
So where does this leave physicians, payers and patients? FDA approval would mark a regulatory first for multi-cancer early detection. Medicare coverage legislation already carves a path if the agency gives the nod. Private insurers will watch the evidence closely. Real-world uptake hinges on how doctors interpret positives and how quickly they complete diagnostic workups. The NHS will review full peer-reviewed data before any broader rollout.
Grail continues to expand its U.S. sales force. New analyses from both trials keep flowing. Follow-up from NHS-Galleri could sharpen the picture on late-stage events in the control arm. Mortality data will take years. In the meantime the test sits at an uneasy crossroads. It has moved the needle on detection timing. Whether that translates into lives saved and costs avoided remains the open question that will decide its commercial fate.
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