Reference laboratories and companion-diagnostic testing
The big labs that run most biomarker tests, and the reagent makers whose stains decide who gets a drug.
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.
How it works
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.
- Scale, turnaround, reimbursement pathways
- Assay-to-assay discordance
- LDT regulation in flux (US)
- Tissue exhaustion with multiple tests
Latest papers
topQuery for this technology: (TITLE:"Reference laboratories and companion-diagnostic testing" OR ABSTRACT:"Reference laboratories and companion-diagnostic testing") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Reference laboratories and companion-diagnostic testing, not a curated reading list.
Pages like this
not linked directly; found by shared links- CompanyQIAGEN
Shares Pre-analytics: blood-collection tubes and tissue fixation, Companion diagnostics and the tag supporting.
- TechnologyWhole-slide scanners and image management
Shares Leica Biosystems (Danaher), Histology automation and IHC autostainers, Roche / Genentech and the tag supporting.
- CompanyStreck
Shares Pre-analytics: blood-collection tubes and tissue fixation and the tag supporting.
- CompanySakura Finetek
Shares Histology automation and IHC autostainers and the tag supporting.
- TechnologyBiobanking and tissue procurement
Shares Pre-analytics: blood-collection tubes and tissue fixation and the tag supporting.
- TechnologyNew short-read sequencing platforms
Shares Roche / Genentech, Comprehensive genomic profiling and the tag supporting.
- CompanyFlatiron Health (Roche)
Shares Roche / Genentech and the tag supporting.
- CompanyThermo Fisher Scientific
Shares Companion diagnostics and the tag supporting.