Galleri cancer test fails to meet main aim in NHS trial, but FDA still endorses it

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The Galleri multicancer detection blood test failed its primary endpoint in an NHS trial but has still received endorsement from a US FDA advisory panel amidst divided opinions on its effectiveness and lack of data on patient outcomes.

The Galleri multicancer detection blood test has been recommended by the US drug regulator’s expert advisory panel, despite concerns over its effectiveness.The decision by the US Food and Drug Administration (FDA) came a day after results from the NHS-Galleri trial, published in the New England Journal of Medicine, showed that the test had failed to meet its primary endpoint: lowering the incidence of stage 3 or 4 cancers across 12 cancers after three screening rounds.1The FDA panel was split on whether it thought the blood test, which retails for $949, was effective, with six members voting in favour of it being effective and four voting against.2Stanley Lipkowitz, senior investigator at the National Institutes of Health (NIH), who voted no when asked about effectiveness, said that when it came to patient outcomes “we don’t have that data.” He also warned that approving the test without data to prove effectiveness would set...