{"entity":{"id":"secore-cdx-hla","kind":"drug","name":"SeCore CDx HLA Sequencing System","aka":[],"tldr":"The blood test that checks a person's tissue type (HLA-A*02) before tebentafusp for uveal melanoma or afamitresgene autoleucel for synovial sarcoma.","summary":"One Lambda's SeCore CDx HLA Sequencing System is listed by the FDA as the companion diagnostic for tebentafusp in uveal melanoma, selecting HLA-A*02:01 (BR220737, 28 November 2022), and for afamitresgene autoleucel in synovial sarcoma (BK241074, 1 August 2024), where the eligible alleles are HLA-A*02:01, 02:02, 02:03 or 02:06 and HLA-A*02:05 excludes. One Lambda is a Thermo Fisher Scientific business.","status":"approved","asOf":"2026-11-03","links":[{"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"},{"label":"Thermo Fisher Scientific: One Lambda","url":"https://www.thermofisher.com/onelambda/us/en/about-us.html"}],"tags":["test"],"related":["mage-a4-ihc-1f9-pharmdx","hla-a-02-01"],"cancers":["uveal-melanoma","synovial-sarcoma"],"sections":[],"technologies":["companion-diagnostic"],"targets":["hla-a"],"drugs":["tebentafusp","afamitresgene-autoleucel"],"companies":["one-lambda"],"institutions":[],"pathways":[],"terms":["ngs","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"SeCore CDx HLA Sequencing System","modality":"HLA sequencing companion diagnostic test (whole blood)","mechanism":"Sequences the HLA-A gene from whole blood to find the tissue type that a T-cell receptor drug can recognise.","approvals":[{"region":"US","year":2022,"indication":"Companion diagnostic for tebentafusp in uveal melanoma (HLA-A*02:01)"},{"region":"US","year":2024,"indication":"Companion diagnostic for afamitresgene autoleucel in synovial sarcoma (eligible HLA-A*02 alleles)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/secore-cdx-hla/","neighbours":{"drug":[{"id":"afamitresgene-autoleucel","kind":"drug","name":"Afamitresgene autoleucel","route":"/drugs/afamitresgene-autoleucel/"},{"id":"mage-a4-ihc-1f9-pharmdx","kind":"drug","name":"MAGE-A4 IHC 1F9 pharmDx","route":"/drugs/mage-a4-ihc-1f9-pharmdx/"},{"id":"tebentafusp","kind":"drug","name":"Tebentafusp","route":"/drugs/tebentafusp/"}],"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/"},{"id":"uveal-melanoma","kind":"cancer","name":"Uveal melanoma","route":"/cancers/uveal-melanoma/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"hla-a","kind":"target","name":"HLA-A","route":"/targets/hla-a/"}],"company":[{"id":"one-lambda","kind":"company","name":"One Lambda","route":"/companies/one-lambda/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}]}}