# Vysis CLL FISH Probe Kit

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

## TL;DR

The FDA-approved blood test for the 17p deletion in chronic lymphocytic leukaemia, approved alongside venetoclax.

## Summary

Abbott Molecular's Vysis CLL FISH Probe Kit was approved on 11 April 2016 (PMA P150041) as the companion diagnostic for venetoclax in B-cell chronic lymphocytic leukaemia with deletion 17p.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: Vysis CLL FISH Probe Kit
- Modality: FISH companion diagnostic test (chromosome 17p deletion, blood)
- Mechanism: Fluorescence in situ hybridisation on peripheral blood cells to detect deletion of chromosome 17p, the region that carries TP53.
- Approvals: US 2016: Companion diagnostic for venetoclax in chronic lymphocytic leukaemia with deletion 17p

## Sources

- FDA PMA P150041: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150041
- 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

- biomarkers: [TP53 mutation and del(17p)](https://onco.cc/biomarkers/tp53-del17p/)
- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Cytogenetics and FISH](https://onco.cc/technologies/cytogenetics-fish/)
- targets: [TP53](https://onco.cc/targets/tp53/)
- drugs: [Venetoclax](https://onco.cc/drugs/venetoclax/)
- 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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