{"entity":{"id":"reference-laboratories","kind":"technology","name":"Reference laboratories and companion-diagnostic testing","aka":[],"tldr":"The big labs that run most biomarker tests, and the reagent makers whose stains decide who gets a drug.","summary":"National reference labs (Labcorp, Quest, NeoGenomics, Mayo Clinic Laboratories, ARUP) and academic pathology departments perform IHC, FISH, and NGS at scale; Roche Tissue Diagnostics (Ventana), Agilent (Dako), and Leica Biosystems make the FDA-approved companion-diagnostic IHC assays (PD-L1 22C3/SP142/SP263, HER2 4B5) and the platforms that run them. Assay-platform pairing is why PD-L1 scores are not interchangeable across drugs.","status":"standard-of-care","asOf":"2026-09-08","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"}],"tags":["supporting"],"related":[],"cancers":[],"sections":["diagnostics"],"technologies":["histopathology-ihc","companion-diagnostic","cgp"],"targets":[],"drugs":[],"companies":["labcorp","quest-diagnostics","neogenomics","roche-genentech","agilent","leica-biosystems"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"principle":"Validated antibody clones, staining platforms, and scoring algorithms tied to a drug label; CLIA/CAP or ISO 15189 accreditation; NGS panels under FDA or LDT oversight.","strengths":["Scale, turnaround, reimbursement pathways"],"limitations":["Assay-to-assay discordance","LDT regulation in flux (US)","Tissue exhaustion with multiple tests"]},"route":"/technologies/reference-laboratories/","neighbours":{"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"ihc-autostainers-histology-automation","kind":"technology","name":"Histology automation and IHC autostainers","route":"/technologies/ihc-autostainers-histology-automation/"},{"id":"histopathology-ihc","kind":"technology","name":"Histopathology & immunohistochemistry","route":"/technologies/histopathology-ihc/"},{"id":"preanalytics-sample-stabilisation","kind":"technology","name":"Pre-analytics: blood-collection tubes and tissue fixation","route":"/technologies/preanalytics-sample-stabilisation/"}],"company":[{"id":"agilent","kind":"company","name":"Agilent Technologies (Dako)","route":"/companies/agilent/"},{"id":"labcorp","kind":"company","name":"Labcorp","route":"/companies/labcorp/"},{"id":"leica-biosystems","kind":"company","name":"Leica Biosystems (Danaher)","route":"/companies/leica-biosystems/"},{"id":"neogenomics","kind":"company","name":"NeoGenomics","route":"/companies/neogenomics/"},{"id":"quest-diagnostics","kind":"company","name":"Quest Diagnostics","route":"/companies/quest-diagnostics/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"roadmap":[{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}