UroVysion Bladder Cancer Kit
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.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2001 | Monitoring for recurrence in patients with previously diagnosed bladder cancer |
| US | 2005 | Aid to diagnosis of bladder cancer in patients with haematuria |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery for this drug: (TITLE:"UroVysion Bladder Cancer Kit" OR ABSTRACT:"UroVysion Bladder Cancer Kit" OR TITLE:"UroVysion" OR ABSTRACT:"UroVysion") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about UroVysion Bladder Cancer Kit, not a curated reading list.
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