# OnCo record her2-testing-assays (drug). 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/drugs/her2-testing-assays/>
  a schema:Drug ;
  onco:kind "drug" ;
  schema:identifier "her2-testing-assays" ;
  schema:name "HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)"@en ;
  schema:description "The tests that grade a breast or stomach cancer's HER2 level, from the original trastuzumab test in 1998 to the new 'HER2-low' and 'ultralow' cut-offs."@en ;
  schema:url <https://onco.cc/drugs/her2-testing-assays/> ;
  schema:dateModified "2026-09-10"^^xsd:date ;
  schema:citation <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980018>, <https://doi.org/10.1200/JCO.22.02864> ;
  onco:status "approved" ;
  onco:tag "test" ;
  onco:modality "HER2 immunohistochemistry and in situ hybridisation companion diagnostic assays" ;
  schema:alternateName "HercepTest / PATHWAY anti-HER2 (4B5) / INFORM HER2 Dual ISH" ;
  onco:approval "US 1998: HercepTest: HER2 overexpression to select trastuzumab in breast cancer (first companion diagnostic)", "US 2010: HER2 testing extended to gastric and GEJ adenocarcinoma with trastuzumab (ToGA)", "US 2022: PATHWAY 4B5 as companion diagnostic for trastuzumab deruxtecan in HER2-low breast cancer", "US 2025: PATHWAY 4B5 extended to HER2-ultralow (IHC 0 with membrane staining)" ;
  onco:cancers <https://onco.cc/cancers/breast-her2-positive/>, <https://onco.cc/cancers/breast-hr-positive/>, <https://onco.cc/cancers/gastric/>, <https://onco.cc/cancers/tnbc/> ;
  onco:technologies <https://onco.cc/technologies/companion-diagnostic/>, <https://onco.cc/technologies/histopathology-ihc/>, <https://onco.cc/technologies/cytogenetics-fish/> ;
  onco:targets <https://onco.cc/targets/her2/> ;
  onco:drugs <https://onco.cc/drugs/trastuzumab/>, <https://onco.cc/drugs/trastuzumab-deruxtecan/> ;
  onco:companies <https://onco.cc/companies/agilent/>, <https://onco.cc/companies/roche-genentech/> ;
  onco:terms <https://onco.cc/terms/her2-positive/>, <https://onco.cc/terms/her2-low/>, <https://onco.cc/terms/ihc/>, <https://onco.cc/terms/fish/> ;
  onco:trials <https://onco.cc/trials/destiny-breast04/>, <https://onco.cc/trials/destiny-breast06/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-schettini-her2-low-features-npj-breast-cancer-2021/>, <https://onco.cc/key-papers/paper-boissiere-michot-her2-ultralow-tnbc-virchows-arch-2026/>, <https://onco.cc/key-papers/paper-wolff-j-clin-oncol/> .