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In 5,461 people sent urgently to hospital with symptoms that might be cancer, the Galleri test was positive in three in four of those found to have cancer at higher stages but in about one in four with stage I cancer.
SYMPLIFY (ISRCTN10226380) was a prospective observational study at 44 NHS hospital sites in England and Wales of the GRAIL methylation test in people aged 18 or older referred from primary care with non-specific symptoms or symptoms of gynaecological, lung or gastrointestinal cancer, run blinded to clinical outcome. Of 5,461 analysable participants, 368 (6.7%) had cancer. The test detected a cancer signal in 323, of whom 244 had cancer: positive predictive value 75.5% (95% CI 70.5 to 80.1), negative predictive value 97.6%, sensitivity 66.3% (61.2 to 71.1) and specificity 98.4% (98.1 to 98.8). Sensitivity rose with stage, from 24.2% (16.0 to 34.1) at stage I to 95.3% at stage IV. The predicted site of origin was accurate in 85.2%.
In people who already have symptoms the test is more often right when positive, because cancer is commoner, but it still misses most stage I cancers, so a negative result cannot cancel an urgent referral.
Shares GRAIL, Positive predictive value (PPV), Galleri, Multi-cancer early detection (MCED).
Shares GRAIL, Positive predictive value (PPV), Galleri, Multi-cancer early detection (MCED).
Shares Cell-free DNA methylation tests, GRAIL, Positive predictive value (PPV), Galleri.
Shares GRAIL, Galleri, Multi-cancer early detection (MCED).
Shares GRAIL, Galleri, Multi-cancer early detection (MCED).
Shares GRAIL, Galleri, Multi-cancer early detection (MCED).
Shares GRAIL, Galleri, Multi-cancer early detection (MCED).
Shares GRAIL, Galleri, Multi-cancer early detection (MCED).
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