3+9p21
chromosome aneuploidy · locus loss
What the test detects
Aneuploidy for chromosomes 3, 7, and 17, and loss of the 9p21 locus —
via fluorescence in situ hybridization on urine specimens.
Indication
Patients with hematuria suspected of having bladder cancer, or those previously diagnosed and being monitored for recurrence.
2
accepted sample types
Sample methods
Urine collected as voided, bladder wash, or catheterized.
Alternatively, 30 mL urine mixed with 15 mL PreservCyt at a 2:1 ratio.
Flexible workflow
Compatible with multiple collection paths so the test fits the visit, not the other way around.
100%
sensitivity, T1 & T2 tumors
Clinical utility
Detects chromosomal abnormalities associated with the development and recurrence
of bladder cancer. Delivers positive / negative results in suspicious cystoscopy
or atypical cytology cases — without interference from BCG, mitomycin C,
or thiotepa in the urine sample.
Performance
100% sensitivity among T1 and T2 tumors. Performs without interference from common intravesical agents.