This test is designed to detect aneuploidy for chromosomes 3, 7, and 17 and loss of the 9p21 locus, via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results are intended for use in conjunction with, and not in lieu of, current standard diagnostic procedures (urine cytology) as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
Patients with hematuria suspected of having bladder cancer, or patients previously diagnosed with bladder cancer.
- Detects chromosomal abnormalities associated with the development and recurrence of bladder cancer.
- Delivers positive/negative results in suspicious cystoscopy or atypical cytology cases.
- Shows 100% sensitivity among T1 and T2 tumors.
- Performs without interference in the presence of substances such as BCG, mitomycin C, and thiotepa in urine samples.
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