# VENTANA ALK (D5F3) CDx Assay

Source: https://onco.cc/drugs/ventana-alk-d5f3-cdx/  
OnCo record `ventana-alk-d5f3-cdx` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The ALK stain for lung cancer, approved as companion to four ALK inhibitors: crizotinib, ceritinib, alectinib and lorlatinib.

## Summary

Ventana Medical Systems' ALK (D5F3) CDx Assay was approved on 12 June 2015 (PMA P140025) as the companion diagnostic for crizotinib in non-small-cell lung cancer. Supplements added ceritinib (26 May 2017), alectinib (6 November 2017) and lorlatinib (3 March 2021). Ventana is part of Roche.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Also known as: Ventana ALK (D5F3) CDx Assay
- Tags: test
- Brand: VENTANA ALK (D5F3) CDx Assay
- Modality: Immunohistochemistry companion diagnostic assay (ALK protein, lung tumour tissue)
- Mechanism: Immunohistochemistry with the D5F3 antibody, reading ALK protein expression in lung tumour tissue as a stand-in for an ALK rearrangement.
- Approvals: US 2015: Companion diagnostic for crizotinib in ALK-positive NSCLC; US 2017: Companion diagnostic for ceritinib and for alectinib; US 2021: Companion diagnostic for lorlatinib

## Sources

- FDA PMA P140025: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140025
- 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

- drugs: [Alectinib](https://onco.cc/drugs/alectinib/), [Ceritinib](https://onco.cc/drugs/ceritinib/), [Crizotinib](https://onco.cc/drugs/crizotinib/), [Lorlatinib](https://onco.cc/drugs/lorlatinib/), [Vysis ALK Break Apart FISH Probe Kit](https://onco.cc/drugs/vysis-alk-break-apart-fish/)
- biomarkers: [ALK fusion (ALK-positive)](https://onco.cc/biomarkers/alk-fusion/)
- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [ALK](https://onco.cc/targets/alk/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)

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