{"entity":{"id":"idea-tr2-biomarker-evidence-grading","kind":"idea","name":"Label every biomarker claim with an evidence phase, like drugs","aka":[],"tldr":"Drugs are labelled phase 1, 2 or 3 so everyone knows how proven they are. Biomarkers should carry a comparable grade, from B1 discovery to B5 utility shown in a randomised trial, so that a marker with only discovery-stage evidence is not mistaken for a validated one in guidelines and papers.","summary":"Biomarker development stages exist in the literature (discovery, analytical validation, clinical validation, clinical utility, as in the Early Detection Research Network's five phases) but are not applied to published claims or guideline statements. A simple grading (B1 discovery, B2 analytically validated, B3 clinically validated retrospectively, B4 prospectively validated, B5 utility shown in a randomised trial) attached to biomarker entries in guidelines, knowledge bases and papers would make the evidence gap visible.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2021.7239"}],"tags":[],"related":["oncokb","civic","esmo-guidelines","nccn"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-biomarker-validation","b-knowledge-diffusion"],"keyPapers":["paper-fernandez-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"After adoption, the proportion of guideline-recommended biomarkers at B4 or above will be reported and will rise year on year, and clinicians will rate biomarker evidence more accurately in surveys.","rationale":"Evidence grading (GRADE, levels of evidence) improved clarity for treatments; biomarkers lack any equivalent that patients and clinicians see.","test":"Grade all biomarkers in two guideline sets and one knowledge base; survey clinicians before and after on their perception of validation status.","maturity":"speculative","actor":"research","cost":"small","horizonYears":2},"route":"/ideas/idea-tr2-biomarker-evidence-grading/","neighbours":{"collection":[{"id":"civic","kind":"collection","name":"CIViC","route":"/collections/civic/"},{"id":"esmo-guidelines","kind":"collection","name":"ESMO Clinical Practice Guidelines & MCBS","route":"/collections/esmo-guidelines/"},{"id":"nccn","kind":"collection","name":"NCCN Guidelines","route":"/collections/nccn/"},{"id":"oncokb","kind":"collection","name":"OncoKB","route":"/collections/oncokb/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-knowledge-diffusion","kind":"bottleneck","name":"Knowledge reaches practice too slowly","route":"/bottlenecks/b-knowledge-diffusion/"}],"paper":[{"id":"paper-fernandez-jama-oncol","kind":"paper","name":"Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue","route":"/key-papers/paper-fernandez-jama-oncol/"}],"technology":[{"id":"serum-tumour-markers","kind":"technology","name":"Serum tumour markers: proper use and misuse","route":"/technologies/serum-tumour-markers/"}]}}