Standards for spatial and multiplex tissue biomarkers before they reach the clinic
New microscopes can measure dozens of proteins at once and map where immune cells sit in a tumour. These readouts could predict immunotherapy response, but every lab does it differently.
Multiplex immunofluorescence and spatial transcriptomics generate spatial biomarkers (immune cell distances, niches, tertiary lymphoid structures) with strong retrospective association to immunotherapy outcome. Platforms, panels, segmentation and metrics are not standardised, so no spatial biomarker has reached clinical validation. A consortium defining minimal reporting, reference tissue, shared segmentation benchmarks and a core panel would let spatial biomarkers be compared across studies and taken into prospective trials.
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
- No one can predict who responds to immunotherapy · Checkpoint drugs cure some patients and do nothing for most. We still cannot tell the two apart before treating.
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