{"entity":{"id":"pathvysion-her2","kind":"drug","name":"PathVysion HER-2 DNA Probe Kit","aka":[],"tldr":"One of the first HER2 gene tests, approved in December 1998 to select trastuzumab for breast cancer.","summary":"Abbott Molecular's PathVysion HER-2 DNA Probe Kit was approved on 11 December 1998 (PMA P980024) and is listed by the FDA as a companion diagnostic for trastuzumab in breast cancer, detecting HER2 gene amplification.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P980024","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980024"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["her2-testing-assays","her2-fish-pharmdx","her2-ish-amplified"],"cancers":["breast-her2-positive"],"sections":[],"technologies":["companion-diagnostic","cytogenetics-fish"],"targets":["her2"],"drugs":["trastuzumab"],"companies":["abbott"],"institutions":[],"pathways":[],"terms":["fish","her2-positive","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"PathVysion HER-2 DNA Probe Kit","modality":"FISH companion diagnostic test (HER2 gene amplification, breast tumour tissue)","mechanism":"Fluorescence in situ hybridisation counting copies of the HER2 (ERBB2) gene in breast tumour cells.","approvals":[{"region":"US","year":1998,"indication":"HER2 gene amplification to select trastuzumab in breast cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/pathvysion-her2/","neighbours":{"drug":[{"id":"her2-fish-pharmdx","kind":"drug","name":"HER2 FISH pharmDx Kit","route":"/drugs/her2-fish-pharmdx/"},{"id":"her2-testing-assays","kind":"drug","name":"HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)","route":"/drugs/her2-testing-assays/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"biomarker":[{"id":"her2-ish-amplified","kind":"biomarker","name":"HER2 ISH amplified (ERBB2 gene amplification)","route":"/biomarkers/her2-ish-amplified/"}],"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cytogenetics-fish","kind":"technology","name":"Cytogenetics and FISH","route":"/technologies/cytogenetics-fish/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"abbott","kind":"company","name":"Abbott Laboratories","route":"/companies/abbott/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"fish","kind":"term","name":"FISH / ISH (in situ hybridisation)","route":"/terms/fish/"},{"id":"her2-positive","kind":"term","name":"HER2-positive (IHC 3+ or ISH-amplified)","route":"/terms/her2-positive/"}]}}