{"entity":{"id":"mage-a4-ihc-1f9-pharmdx","kind":"drug","name":"MAGE-A4 IHC 1F9 pharmDx","aka":[],"tldr":"The stain that shows whether a synovial sarcoma makes MAGE-A4, the target of the engineered T-cell therapy afamitresgene autoleucel.","summary":"Agilent's MAGE-A4 IHC 1F9 pharmDx was approved on 1 August 2024 (PMA P230016) as the companion diagnostic for afamitresgene autoleucel in synovial sarcoma with MAGE-A4 protein overexpression. Eligibility also needs a matching HLA type, tested separately with the SeCore CDx HLA Sequencing System.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P230016","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230016"},{"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":["secore-cdx-hla","hla-a-02-01"],"cancers":["synovial-sarcoma"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["mage-a4"],"drugs":["afamitresgene-autoleucel"],"companies":["agilent"],"institutions":[],"pathways":[],"terms":["ihc","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"MAGE-A4 IHC 1F9 pharmDx","modality":"Immunohistochemistry companion diagnostic assay (MAGE-A4 protein, sarcoma tissue)","mechanism":"Immunohistochemistry with the 1F9 antibody for MAGE-A4 protein in synovial sarcoma tissue.","approvals":[{"region":"US","year":2024,"indication":"Companion diagnostic for afamitresgene autoleucel in synovial sarcoma (MAGE-A4 protein)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mage-a4-ihc-1f9-pharmdx/","neighbours":{"drug":[{"id":"afamitresgene-autoleucel","kind":"drug","name":"Afamitresgene autoleucel","route":"/drugs/afamitresgene-autoleucel/"},{"id":"secore-cdx-hla","kind":"drug","name":"SeCore CDx HLA Sequencing System","route":"/drugs/secore-cdx-hla/"}],"biomarker":[{"id":"hla-a-02-01","kind":"biomarker","name":"HLA-A*02:01 (HLA typing for TCR therapies)","route":"/biomarkers/hla-a-02-01/"}],"cancer":[{"id":"synovial-sarcoma","kind":"cancer","name":"Synovial sarcoma","route":"/cancers/synovial-sarcoma/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"histopathology-ihc","kind":"technology","name":"Histopathology & immunohistochemistry","route":"/technologies/histopathology-ihc/"}],"target":[{"id":"mage-a4","kind":"target","name":"MAGE-A4","route":"/targets/mage-a4/"}],"company":[{"id":"agilent","kind":"company","name":"Agilent Technologies (Dako)","route":"/companies/agilent/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"}]}}