# Reference laboratories and companion-diagnostic testing

Source: https://onco.cc/technologies/reference-laboratories/  
OnCo record `reference-laboratories` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-08
- Tags: supporting
- 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

## Sources

- FDA: list of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Comprehensive genomic profiling](https://onco.cc/technologies/cgp/), [Histology automation and IHC autostainers](https://onco.cc/technologies/ihc-autostainers-histology-automation/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/), [Pre-analytics: blood-collection tubes and tissue fixation](https://onco.cc/technologies/preanalytics-sample-stabilisation/)
- companies: [Agilent Technologies (Dako)](https://onco.cc/companies/agilent/), [Labcorp](https://onco.cc/companies/labcorp/), [Leica Biosystems (Danaher)](https://onco.cc/companies/leica-biosystems/), [NeoGenomics](https://onco.cc/companies/neogenomics/), [Quest Diagnostics](https://onco.cc/companies/quest-diagnostics/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- roadmaps: [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)

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