Specimen site, source: A. Urine/ Bladder washing, FISH (UroVysion): Urine/ Catheterized, FISH (UroVysion): Urine/ Ureter washing, FISH (UroVysion): Urine/ Renal pelvis washing, FISH (UroVysion): Urine/ Not specified, FISH (UroVysion): RESULT: NEGATIVE- NORMAL Interphase fluorescence in situ hybridization (FISH) analysis was performed on nuclei derived from a urine specimen. A normal signal pattern was observed for cen 3, cen 7, cen 17 and the 9p21 probes (2R2G2A2Y). This represents a NEGATIVE (normal) result. POSITIVE- ABNORMAL ANEUPLOIDY Interphase fluorescence in situ hybridization (FISH) analysis was performed on nuclei derived from a urine specimen. Gains in two or more of the centromeric FISH probe signals of chromosomes 3, 7 or 17 (cen 3, cen 7, cen 17) were observed indicating abnormal aneuploidy. This represents a POSITIVE (abnormal) result indicative of aneuploidy involving chromosome 3, 7 and 17 typically associated with development and progression of urothelial carcinoma and generally correlates with a high-grade tumor. The 9p21 probe had a normal signal pattern (2Y). POSITIVE- ABNORMAL HOMOZYGOUS 9p21 DELETION Interphase fluorescence in situ hybridization (FISH) analysis was performed on nuclei derived from a urine specimen. Lack of probe 9p21 signals (0Y) was observed indicating homozygous deletion of the 9p21 loci (p16 gene). The signal patterns for probes 3, 7 and 17 (2R2G2A) were within the normal reference range. This represents a POSITIVE (abnormal) result. Homozygous deletion of the 9p21 loci is associated with urothelial carcinoma and generally correlates with a lower grade lesion compared to that of aneuploidy of chromosomes 3, 7 and 17. POSITIVE- ABNORMAL ANEUPLOIDY AND HOMOZYGOUS 9p21 DELETION Interphase fluorescence in situ hybridization (FISH) analysis was performed on nuclei derived from a urine specimen. Gains in two or more of the centromeric FISH probe signals of chromosomes 3, 7 or 17 (cen 3, cen 7, cen17) were observed. In addition, lack of probe 9p21 signals with a 0Y signal pattern was also observed. This represents a POSITIVE result indicative of aneuploidy involving chromosome 3, 7 and 17 as well as homozygous 9p21 loss. This represents a POSITIVE (abnormal) result and is associated with development and progression of urothelial carcinoma and generally correlates with a high-grade tumor. BORDERLINE ABNORMAL ANEUPLOIDY, SEE COMMENT The above results identify abnormal cells with aneuploidy of 2 or more centromeric probes. Although this finding is below the FDA cutoff of 4 abnormal cells, the complete significance of this finding is uncertain and in patients with prior urothelial carcinoma this may be associated with disease. If clinically indicated, repeat studies may be of value. INCONCLUSIVE (insufficient nuclei available for analysis) Interphase fluorescence in situ hybridization (FISH) analysis was performed on nuclei derived from a urine specimen. An insufficient number of nuclei (less than 25 cells) were available for analysis. This test is INCONCLUSIVE. -------------------------------------------------------------------------- FISH PROBE SCORES: NORMAL (2R2G2A2Y): ANEUPLOIDY ONE CENTROMIC PROBE: ANEUPLOIDY OF 2 OR MORE CENTROMIC PROBES: HOMOZYGOUS DELETION OF 9p21: HOMOZYGOUS DELETION AND ANEUPLOIDY OF 2 OR MORE CENTROMIC PROBES: TOTAL NUCLEI SCORED: FISH Probes: Red (R) Chromosome 3: CEN3; Green (G) Chromosome 7: CEN 7; Aqua (A) Chromosome 17: CEN 17; Yellow (Y) Chromosome 9p21: p16 -------------------------------------------------------------------------- Results from this test (UroVysion tm) are intended for use as a non-invasive method for the diagnosis and monitoring of tumor recurrence in conjunction with cystoscopy in patients either suspected of having or previously diagnosed with bladder cancer. The results of this assay should be interpreted in association with other pathology data. This test was performed using manual analysis. The performance characteristics of this test have been validated by UF Pathology Labs.