| IFA Assays | ||
 |
Bladder Cancer | |
Main Page on Bladder Cancer |
||
|
Overview of Bladder Cancer |
||
|
FAQ
on Bladder Cancer |
||
 ImmunoCyt™
/ uCyt+™ |
||
|
Summary of Procedure |
||
|
FAQ on ImmunoCyt™ / uCyt+™ |
||
|
Certification |
||
The
ImmunoCyt™/uCyt+™ kit is available in a convenient, ready-to-use
50 test kit format.
This bladder cancer diagnostic test is commercialized
under two names, ImmunoCyt™ and uCyt+™. In particular, in
the United States, it is only distributed under the brand name ImmunoCyt™
with the indication for the monitoring of bladder tumors under FDA clearance
in conjunction with urinary cytology and cystoscopy. Please take this
information into consideration when reading information about this product.
Product principle
ImmunoCyt™/uCyt+™ contains a cocktail of three monoclonal
antibodies labeled with fluorescent markers. The cocktail of antibodies
has been shown to react with a mucin glycoprotein as well as a glycoform
of CEA. The test detects cellular markers specific for bladder cancer
in exfoliated cells isolated from urine sample. This non-invasive test,
when coupled with urine cytology, proves to be more sensitive than urine
cytology alone or other currently available tumor markers.
The current standard method for non-invasive detection of bladder cancer is urinary cytology, which consists of identifying the presence of cancer cells in urine. Urinary cytology has high specificity but poor sensitivity, typically no greater than 35% to 40%[1]. This sensitivity varies according to the stage and grade of the tumor.
ImmunoCyt™/uCyt+™ uses an immunocytofluorescence technique based on a cocktail of patented monoclonal antibodies labeled with fluorescent markers. This monoclonal antibody cocktail consists of two antibodies (M344 and LDQ10) which have been shown to react with a mucin glycoprotein, and one antibody (19A211) which has been shown to be specific to a glycosylated form of carcinoembryonic antigen. These antigens are expressed by tumor cells found in the majority of bladder cancer patients and occasionally on tumor cells of some patients with prostate cancer. They can be detected in tumor cells exfoliated in the urine and are not expressed in normal genito-urinary tissues, with the exception of a few umbrella cells in a small percentage of patients.
Normal squamous cells frequently present in urine samples of female patients may show a weak spontaneous red fluorescence. The weak fluorescence and the typical morphology of squamous cells clearly distinguish them from urothelial cells.
ImmunoCyt™/uCyt+™ is carried out in parallel with cytology to improve cytology’s sensitivity at detecting tumor cells in the urine of patients, especially those with low-stage, low-grade tumors. The concomitant use of classical cytology and ImmunoCyt™/uCyt+™ can substantially improve the detection of bladder cancer. As shown in the Performance Advantages section, a sensitivity of 87% has been obtained when cytology and ImmunoCyt™/uCyt+™ were used together.
Performance advantages
Non-invasive test
This simple antibody-based test is performed on voided urine in the pathology
lab in conjunction with the cytology.
High sensitivity
With an overall sensitivity of greater than 87%, ImmunoCyt™/uCyt+™
complements cytology’s high specificity. ImmunoCyt™/uCyt+™
provides more diagnostic precision when used in conjunction with urine
cytology in cases of atypia and dysplasia often found in low-grade tumors.
Reliable negative predictive
value
With a negative predictive value over 94%, ImmunoCyt™/uCyt+™
provides patients and physicians with a greater peace of mind.
Performance analysis
The following table and chart have been compiled from different studies
and present the performance analysis of the ImmunoCyt™/uCyt+™
test (see references below).
| Overall Sensitivity and Specificity | Total cases | |
|---|---|---|
| Se ImmunoCyt™ / uCyt+™ and Cytology Sp ImmunoCyt™ / uCyt+™ and Cytology |
87% 71% |
1347 4273 |
| Se ImmunoCyt™ / uCyt+™ alone Sp ImmunoCyt™ / uCyt+™ alone |
81% 72% |
1496 4644 |
| Se Cytology Sp Cytology |
45% 97% |
1473 4523 |
| Sensitivity by grades and stages | ||
| Se grade 1 ImmunoCyt™ / uCyt+™ alone Se Gr 1 ImmunoCyt™ / uCyt+™ and Cytology Se Gr 1 Cytology |
77% 78% 11% |
408 408 400 |
| Se grade 2 ImmunoCyt™ / uCyt+™ alone Se Gr 2 ImmunoCyt™ / uCyt+™ and Cytology Se Gr 2 Cytology |
83% 89% 45% |
453 453 439 |
| Se grade 3 ImmunoCyt™ / uCyt+™ alone Se Gr 3 ImmunoCyt™ / uCyt+™ and Cytology Se Gr 3 Cytology |
87% 94% 72% |
421 421 413 |
| Se stage Ta ImmunoCyt™ / uCyt+™ alone Se Stg Ta ImmunoCyt™ / uCyt+™ and Cytology Se Stg Ta Cytology |
80% 83% 25% |
754 754 736 |
| Se stage T1 ImmunoCyt™ / uCyt+™ alone Se Stg T1 ImmunoCyt™ / uCyt+™ and Cytology Se Stg T1 Cytology |
86% 93% 64% |
271 271 264 |
| Se stage T2/3 ImmunoCyt™ / uCyt+™ alone Se Stg T2/3 ImmunoCyt™ / uCyt+™ and Cytology Se Stg T2/3 Cytology |
79% 90% 76% |
164 164 160 |
| Ptis ImmunoCyt™ / uCyt+™ alone Ptis ImmunoCyt™ / uCyt+™ and Cytology Ptis Cytology |
97% 100% 81% |
103 103 101 |
Updated September 2006
Se: Sensitivity Sp: Specificity
Roc
Curve ImmunoCyt™ /uCyt+™
- Current bladder tumor tests: does their projected utility fulfill clinical necessity? V.B. Lokeshwar and M.S. Soloway. Journal of Urology, 2001.
- uCyt+: Test diagnostique in vitro pour la détection de tumeurs vésicales. Mode opératoire, Canada et Europe / ImmunoCyt: An in vitro diagnostic test for the monitoring of bladder cancer as per FDA clearance. Mode opératoire, États-Unis
- ImmunoCyt a useful method in the follow-up protocol for patients with urinary bladder carcinoma. Hans Olsson, Björn Zackrisson. Scandinavian Journal of Urology and Nephrology (2001)
- The role of uCyt+ in the detection and surveillance of urothelial carcinoma. M. Lodde, C. Mian, G. Negri, L. Berner, N. Maffei, L. Lusuardi, S. Palermo, M. Marberger, C. Brössner, A. Pycha. Urology (January 2003)
- ImmunoCyt test improves the diagnostic accuracy of urinary cytology : results of a french multicenter study. C. Pfister, D. Chautard, M. Devonec, P. Perrin, D. Chopin, P. Rischmann, O. Bouchot, D. Beurton, C. Coulange, J.-J. Rambeaud Journal of Urology (March 2003)
- Sensitivity of ImmunoCyt in patients with transitional cell carcinoma of the bladder. M. Carter, K. Prestage, T. Kinahan, C. Topp, E. Sikaik, G. Randhawa. CUA (2000)
- ImmunoCyt: A new tool for the detection of transitional cell cancer of the urinary tract. M. Lodde, C. Mian, A. Pycha, H. Wiener, A. Haitel, M. Marberger AUA (1999)
- El seguimiento con imunocyt de los pacientes con carcinoma urotelial vesical superficial es coste-efectivo respecto al convencional. B. M. Lopez, T. F. Aparicio, G. H. Villaplana, P. G. Martinez-Valls, J. L. Garcia, A. C. Benito LXVII Congreso Nacional de Urologia, Actas Urologicas Españolas (2002)
- Diagnosic value of the ImmunoCyt test detecting urothelial cell carcinoma of the bladder. Hautmann S., Toma M., Friedrich M., Jäckel T., Erbersdobler A., Hellstern A., Huland H. Hamburg. World Journal of Urology (2004)
- ImmunoCyt/uCyt+ improves the sensibility of urine cytology in patients followed for urothelial carcinoma. Têtu, B., Tiguert, R., Haul, F., Fradet, Y. Modern pathology (2005)
- Liquid-based cytology as a tool for the performance of uCyt+ and UroVysion Multicolour-Fish in the detection of urothelial carcinoma. Mian, C., Lodde, M., Comploj, E., Negri, G., Egarter-Vigl, E., Lusuardi, L., Palermo, S., Marberger, M., Pycha, A. Cytopathology (2003), 14:338-342
- Monitoring Superficial Bladder Cancer (BC) with the ImmunoCyt Fluorescent Cytology Test. Edward Messing, Howard Korman, Brian Stork, Edward Barker, Jeanne Underhill, Lisa Teot, David Bostwick. Journal of Urology (2005)
- Diagnostic efficacy of the ImmunoCyt test to detect superficial bladder cancer recurrence. J. L. J. Vriesema, F. Atsma, L. A. L. M. Kiemeney, W. P. Peelen, J. A. Witjes, J. A. Schalken. Urology (2001)
- Accuracy of ImmunoCyt assay in the diagnosis of transitional cell carcinoma of the urinary bladder. Feil, G, Zumbrägel A, Paulgen-Nelde HJ, Hennelotter J, Maurer S, Krause S, Bichler KH, Stenzl A. Der Urologe (2003)
- uCyt+/ImmunoCyt in the detection of recurrent urothelial carcinoma. C. Milan, K. Maier, E. Comploj, M. Lodde, L. Berner, L. Lusuardi, S. Palermo, F. Vittadello, A. Pycha. Cancer Cytopathology (2006)
- The uCyt+ test: an alternative to cytoscopy for a less invasive follow-up of patients with low risk of urothelial carcinomas. M. Lodde, C. Mian, E. Comploj, S. Palermo, El. Longhi, M. Marberger, A. Pycha. Urology (2006)
100 Ford Road Suite 100-08 Denville New Jersey
USA 07834 tel 973.625.8822 toll-free 800.221.5598 fax 973.625.8796
e-mail
info@scimedx.com© 2007 Scimedx Corporation. All rights reserved. |