Grail’s Galleri blood-based cancer detection test appears headed towards approval by the FDA after it passed a trio of votes from an advisory committee Sept. 23. However, a closer look at the votes — especially the split vote on the question of efficacy — and the debate that preceded it revealed just how much remains unsettled about what the test achieves. As this is the first test of its kind, with more to follow, how FDA chooses to regulate multiple aspects will reveal a lot about where the field is and what it still may need to prove.
And it may be the last chance science-minded regulators have to put some reins on Galleri before it gets out into a world where Grail has used its money and influence to tilt the market in its favor.
Alex Dickinson, a former Illumina executive who has built a large following on LinkedIn, in part due to his sharp critiques of Grail and Galleri, joined me to break the situation down.
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