# UroVysion Bladder Cancer Kit

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

## TL;DR

A urine test that looks for chromosome changes in shed bladder cells, approved for people with blood in the urine and for follow-up after bladder cancer.

## Summary

UroVysion (Abbott Molecular) was approved by the FDA in 2001 for monitoring recurrence in patients with previously diagnosed bladder cancer and on 24 January 2005 (PMA P030052) for the initial work-up of haematuria. It is more sensitive than urine cytology, particularly for high-grade disease, but less specific, and an 'anticipatory positive' result can precede visible recurrence by months. Guidelines regard urine markers, including UroVysion, as adjuncts to cystoscopy rather than replacements; its main clinical use is resolving atypical cytology and assessing response to BCG.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- Brand: UroVysion
- Modality: Urine FISH cytogenetic test (bladder cancer)
- Mechanism: Multicolour fluorescence in situ hybridisation on urine cells for aneuploidy of chromosomes 3, 7 and 17 and loss of the 9p21 locus (CDKN2A).
- Approvals: US 2001: Monitoring for recurrence in patients with previously diagnosed bladder cancer; US 2005: Aid to diagnosis of bladder cancer in patients with haematuria

## Notes

- What a result means: abnormal chromosomes in urine cells raise the suspicion of bladder cancer and usually lead to cystoscopy and biopsy; a normal result does not fully exclude low-grade tumours.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/UroVysion
- FDA PMA P030052: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030052

## Connected records

- drugs: [Cxbladder](https://onco.cc/drugs/cxbladder/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Bladder EpiCheck urine methylation test](https://onco.cc/technologies/bladder-epicheck/), [Cystoscopy, blue-light imaging & TURBT](https://onco.cc/technologies/cystoscopy-turbt/), [Cytogenetics and FISH](https://onco.cc/technologies/cytogenetics-fish/), [Urine tests for bladder cancer (cytology, FISH, RNA and methylation)](https://onco.cc/technologies/urine-bladder-cancer-tests/)
- companies: [Abbott Laboratories](https://onco.cc/companies/abbott/)
- terms: [FISH / ISH (in situ hybridisation)](https://onco.cc/terms/fish/)
- targets: [CDKN2A](https://onco.cc/targets/cdkn2a/)

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