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The largest study of Grail's $950 Galleri blood test found it identified four times more cancers when added to standard screening, though it missed 2,114 cancers and did not reduce late-stage diagnoses as intended.
Grail presented results from its largest study to date at the American Society of Clinical Oncology meeting in Chicago. The study tracked more than 140,000 older people in the UK who took the company's $950 Galleri blood test each year for three years. Insider reported that the test searches for upwards of 50 types of cancer by looking for tell-tale signs of cancer DNA in blood.
The study did not achieve its goal of meaningfully curbing late-stage cancers. Grail President and incoming CEO Joshua Ofman said the test still produced a clear benefit. "When you add Galleri to single cancer, standard-of-care screening, we found four times more cancer in the population," Ofman told Insider.
An additional 937 cancers were detected by the Galleri test. Of those cancers found by the test, 54% were in Stages 3 and 4. People who took the test had fewer Stage 4 diagnoses and more cases identified at Stage 3.
After three years, Stage 1 and 2 cancer detection improved by 16% overall. The test showed larger gains for certain cancers that lack routine screening. Grail doubled the number of Stage 1 and 2 ovarian cancer cases detected.
3% increase in Stage 1 and 2 esophagus cancer diagnoses. The test demonstrated high specificity. 5%.
Still, 864 people received a cancer signal from the test but were not diagnosed with cancer afterward. Grail founding CEO Jeff Huber addressed the false positive results. "When you get a Grail test result, and it says you have cancer, you can be highly, highly, highly confident you have cancer," Huber said.
He added that previous research showed about a third of false positive tests later became cancer diagnoses when followed over longer periods. Dr. Scott Ramsey, who directs the Institute for Cancer Outcomes Research at Fred Hutch Cancer Center and was not involved in the study, said a positive result would prompt further investigation.
"If I did Grail and I had a positive test, I would be worried, I would be looking for cancer," Ramsey said. The test missed more cancers than it found. In the study, 2,114 people with negative Galleri results were diagnosed with cancer in the following 12 months through traditional methods.
Grail's test has a sensitivity around 30%. "If it's a negative test, you should not feel safe because they are not very sensitive," Ramsey said. Grail's test is not yet approved by the US Food and Drug Administration.
It is available across the country with a doctor's prescription or through telehealth services like Hims & Hers. Huber said he gets a Galleri test every year along with regular full-body MRIs and colonoscopies.
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