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Increase bladder cancer detection sensitivity to ≥ 95 % in voided urines from patients with a history of bladder urothelial carcinoma.
The sensitivity of cytology is too low to monitor for bladder cancer recurrence when used alone, both for high grade and especially low grade urothelial carcinoma.
Delay in diagnosis can lead to grade and stage progression and adverse outcome.
ImmunoCyt™ (DiagnoCure) and ImmunoCyt™ plus cytology have significantly greater sensitivity than cytology for detecting recurrent urothelial carcinoma in voided urines (Table).
ImmunoCyt™ has ~95 % sensitivity for urothelial carcinoma, both for high grade AND low grade disease.
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Table: Sensitivity of Urine Cytology (Cyto) vs ImmunoCyt (uCyt) for detecting Urothelial Carcinoma |
|
Study |
Gr I/III |
Gr II/III |
Gr III/III |
Reference |
|
Cyto |
uCyt |
Cyto |
uCyt |
Cyto |
uCyt |
Combined |
|
Fradet, Y et ala |
30 % |
85 % |
51 % |
93 % |
76 % |
96 % |
100 % |
Can J Urol 4:400,1997 |
|
Mian, C et al |
4 % |
84 % |
52 % |
84 % |
79 % |
90 % |
97 % |
J Urol 161:1486,1999 |
|
Pfister, C et al |
18 % |
61 % |
46 % |
76 % |
64 % |
77 % |
87 % |
J Urol 169:921,2003 |
|
Lodde, M et ala |
4 % |
78 % |
20 % |
70 % |
94 % |
94 % |
100 % |
Urol 61:243,2003 |
|
Tetu, B et alb |
7 % |
71 % |
18 % |
79 % |
53 % |
85 % |
93 % |
Mod Path 18:83,2005 | a,Data for monitoring for urothelial carcinoma recurrence only; b,Data for Low malignant potential, low grade, high grade tumors (vs. 1973 WHO I-III/III in other studies) ___________________________________________________________________________________
Augment cytology with appropriate molecular testing at MOD Lab.
When you get a urine cytology specimen in a patient with a history of bladder carcinoma, send a portion off to MOD Lab for ImmunoCyt™… or …“reflex” to MOD for ImmunoCyt when the cytology diagnosis is negative1
MOD Lab uses ThinPrep® (Cytyc) slides for ImmunoCyt™, including the new UroCyte™ (Cytyc) slides. If your group is using ThinPrep® slides for cytology, simply send a spray-fixed additional slide (Contact MOD Lab for specifics). If not, just send fixed urine.
Practice better pathology.
Give your demanding clinicians ≥ 95 % sensitivity for detecting recurrent urothelial carcinoma in non-invasive specimens.
With the high negative predictive value of ImmunoCyt™, a negative test means the patient can just be followed, as per routine.
With a positive test, cystoscopy can be performed, or “reflex” UroVysion™ FISH (Vysis) can further confirm the diagnosis and reduce false positives, providing even greater confidence for proceeding to cystoscopy.
Make the SMART choice…with MOD Lab.
With your expertise in cytology and carefully chosen molecular testing with MOD Lab, make your diagnoses in non-invasive urothelial carcinoma testing as close to perfect as can currently be achieved.
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1 For non-negative (i.e., atypical or suspicious) urine cytology in patients with a history of bladder cancer or in initial evaluation for hematuria, MOD Lab recommends “reflex” UroVysion™ FISH at MOD. ThinPrep® (Cytyc) slides or fixed urine can be sent.
See also bladder cancer link for discussion regarding the coordinated use of cytology, ImmunoCyt, and UroVysion FISH in diagnosing urothelial carcinoma |