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Background: The finding of a suspicious urinary cytology is not uncommon in melanoma patients, in as much as morphology alone is often unable to distinguish the variable cytological features of melanoma cells. To date, although tyrosinase reverse transcription (RT)-PCR assay has been used to identify melanoma cells in peripheral blood and tissues, this method has not been applied to the analysis of urine samples. Methods: RT-PCR mRNA tyrosinase expression was analysed in 79 urine samples from patients with metastatic melanoma and correlated with standard morphology/immunocytology. The results were compared with the disease course and presence of genito-urinary involvement. Results: A positive RT-PCR expression was found in 18/ 79 urine samples from patients with metastases; four of the 18 patients had positive cytology, nine had atypical cytology, and five had negative cytology. Genito-urinary metastases were demonstrated in 27.8% tyrosinase-positive patients but in only 9.8% of the negative patients. The majority of tyrosinase-positive patients had a progressive disease unresponsive to chemotherapy. Urine samples from 20 patients with non-melanoma cancer and 20 healthy subjects were all negative. Conclusions: Our data demonstrate the higher sensitivity of RT-PCR compared with standard cytology in detection of urinary melanoma cells, and suggest that this assay could be used as an additional tool in the presence of negative or suspicious cytology. [ABSTRACT FROM AUTHOR]