# OnCo record b-biomarker-validation (bottleneck). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/bottlenecks/b-biomarker-validation/>
  a schema:Thing ;
  onco:kind "bottleneck" ;
  schema:identifier "b-biomarker-validation" ;
  schema:name "Biomarkers are not validated or standardised"@en ;
  schema:description "Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab."@en ;
  schema:url <https://onco.cc/bottlenecks/b-biomarker-validation/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://doi.org/10.1001/jamaoncol.2021.7239>, <https://doi.org/10.1016/j.jtho.2016.11.2228>, <https://doi.org/10.1136/jitc-2019-000147> ;
  onco:related <https://onco.cc/ideas/idea-ai-her2-low-scoring/>, <https://onco.cc/ideas/idea-trop2-pet-selection/>, <https://onco.cc/collections/adcdb/>, <https://onco.cc/ideas/idea-tr2-cdx-mutual-recognition/>, <https://onco.cc/ideas/idea-tr2-psma-volume-qualification/>, <https://onco.cc/ideas/idea-tr2-bicr-discordance-public/>, <https://onco.cc/ideas/idea-tr2-biomarker-evidence-grading/>, <https://onco.cc/ideas/idea-tr2-tmb-calibration-standard/>, <https://onco.cc/ideas/idea-tr2-hrd-functional-standard/>, <https://onco.cc/ideas/idea-tr2-preanalytics-in-report/>, <https://onco.cc/ideas/idea-tr2-cutpoint-lock/>, <https://onco.cc/ideas/idea-tr2-spatial-biomarker-standards/>, <https://onco.cc/ideas/idea-tr2-radiomics-ibsi-mandate/>, <https://onco.cc/ideas/idea-tr2-biomarker-cwe/>, <https://onco.cc/ideas/idea-tr2-label-assay-concordance/>, <https://onco.cc/ideas/idea-tr2-positivity-rate-surveillance/>, <https://onco.cc/ideas/idea-moon-biomarker-validation-utility/> ;
  onco:cancers <https://onco.cc/cancers/breast-her2-positive/>, <https://onco.cc/cancers/breast-hr-positive/>, <https://onco.cc/cancers/nsclc/>, <https://onco.cc/cancers/ovarian/>, <https://onco.cc/cancers/gastric/>, <https://onco.cc/cancers/urothelial/> ;
  onco:technologies <https://onco.cc/technologies/histopathology-ihc/>, <https://onco.cc/technologies/companion-diagnostic/>, <https://onco.cc/technologies/digital-pathology-ai/>, <https://onco.cc/technologies/hrd-testing/>, <https://onco.cc/technologies/cgp/>, <https://onco.cc/technologies/trop2-pet/>, <https://onco.cc/technologies/her2-pet/> ;
  onco:targets <https://onco.cc/targets/her2/>, <https://onco.cc/targets/pdl1/>, <https://onco.cc/targets/trop2/>, <https://onco.cc/targets/cldn18-2/> ;
  onco:drugs <https://onco.cc/drugs/foundationone-cdx/>, <https://onco.cc/drugs/trastuzumab-deruxtecan/> ;
  onco:companies <https://onco.cc/companies/foundation-medicine/>, <https://onco.cc/companies/paige/>, <https://onco.cc/companies/pathai/>, <https://onco.cc/companies/roche-genentech/> ;
  onco:terms <https://onco.cc/terms/her2-low/>, <https://onco.cc/terms/tps/>, <https://onco.cc/terms/cps/>, <https://onco.cc/terms/tmb/>, <https://onco.cc/terms/hrd/>, <https://onco.cc/terms/msi/>, <https://onco.cc/terms/ihc/>, <https://onco.cc/terms/companion-diagnostic-term/> ;
  onco:trials <https://onco.cc/trials/destiny-breast04/>, <https://onco.cc/trials/destiny-breast06/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-fernandez-jama-oncol/>, <https://onco.cc/key-papers/paper-hirsch-j-thorac-oncol/>, <https://onco.cc/key-papers/paper-merino-j-immunother-cancer/> .