# Vysis ALK Break Apart FISH Probe Kit

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

## TL;DR

The test approved with crizotinib in 2011 to find ALK-rearranged lung cancer, still listed as companion to brigatinib and ensartinib.

## Summary

Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit was approved on 26 August 2011 (PMA P110012) as the companion diagnostic for crizotinib in ALK-rearranged non-small-cell lung cancer. Supplements added brigatinib (22 May 2020) and ensartinib (5 August 2025). The Ventana ALK (D5F3) CDx Assay detects the same alteration as protein by immunohistochemistry.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: Vysis ALK Break Apart FISH Probe Kit
- Modality: FISH companion diagnostic test (ALK rearrangement, lung tumour tissue)
- Mechanism: Fluorescence in situ hybridisation with probes either side of the ALK gene: when the two signals split apart, the gene has been rearranged.
- Approvals: US 2011: Companion diagnostic for crizotinib in ALK-rearranged NSCLC; US 2020: Companion diagnostic for brigatinib; US 2025: Companion diagnostic for ensartinib

## Sources

- FDA PMA P110012: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110012
- 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: [Brigatinib](https://onco.cc/drugs/brigatinib/), [Crizotinib](https://onco.cc/drugs/crizotinib/), [Ensartinib](https://onco.cc/drugs/ensartinib/), [VENTANA ALK (D5F3) CDx Assay](https://onco.cc/drugs/ventana-alk-d5f3-cdx/)
- 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/), [Cytogenetics and FISH](https://onco.cc/technologies/cytogenetics-fish/)
- targets: [ALK](https://onco.cc/targets/alk/)
- companies: [Abbott Laboratories](https://onco.cc/companies/abbott/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [FISH / ISH (in situ hybridisation)](https://onco.cc/terms/fish/)

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