Xpert® Bladder Cancer Monitor

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Qualitative monitoring for recurrence in patients previously diagnosed with bladder cancer in around 90 minutes

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10 Tests

GXBLAD-CM-CE-10

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Collection devices

Kit, Xpert Urine Transport Reagent Kit (30 Collection Devices)

GXUTR-CE-30

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The Need

In Europe 415000 people live with bladder cancer.¹ The 5-year survival rates for patients diagnosed with non-muscle invasive bladder cancer (NMIBC) are very good (~93%). However patients with NMIBC have a high risk of tumour recurrence and progression.²
Patients are assigned a risk score (low, medium, high)³ based on the European Organisation for Research & Treatment of Cancer (EORTC) scoring system to help determine their likelihood of recurrence and/or progression.
White light cystoscopy and urine cytology are still considered the best way of patient surveillance after NMIBC.
Limitations are associated with both methodologies

White light cystoscopy demonstrates a lack of sensitivity for flat lesions⁴
Cystoscopies are unpleasant and may cause discomfort for patients⁵
Guideline compliance varies, with significant numbers of patients not receiving all of the follow-up examinations suggested⁶

Cytology has low sensitivity for low and intermediate grade tumours⁷

(1) Ferlay et al. Eur J Cancer. 2013 Apr;49(6):1374-403).;
(2) Babjuk et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol. 2013;64(4):639–53.;
(3) Sylvester et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol 2006. 49(3): p. 466-5; discussion 475-7;
(4) Burger et al. Photodynamic diagnosis of non-muscle-invasive bladder cancer with hexaminolevulinate cystoscopy: a meta-analysis of detection and recurrence based on raw data. Eur Urol. 2013;64(5):846–54.;
(5) Yeo et al. Listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction in patients: a pilot randomized controlled trial. J Endourol. 2013;27(4):459–62.;
(6) Chamie et al. Quality of Care in Patients with Bladder Cancer: A Case Report Cancer. 2012 Mar 1; 118(5): 1412–1421;
(7) Wiener et al. Accuracy of urinary cytology in the diagnosis of primary and recurrent bladder cancer. Acta Cytol 1993; 37: 163-16.

The Solution

It has been proven that there is a statistically significant survival advantage found among those who received at least half of the care recommended in local monitoring guidelines.⁶
Urine markers have the capacity to add value to cystoscopy by

Providing information to support clinical decision making in follow-up of patients with low-/intermediate-risk NMIBC⁸
Identifying situations in which the use of molecular markers in high grade tumours may prove beneficial for patient diagnosis and surveillance⁹

Improving compliance through a combination of invasive and non-invasive surveillance methods to ensure that guidelines are followed may help to improve bladder cancer care.
Xpert Bladder Cancer Monitor

Xpert Bladder Cancer Monitor is a non-invasive biomarker test with proven clinical sensitivity and specificity for low and high-grade bladder cancer.
It utilizes the Cepheid GeneXpert Instrument Systems to measure the expression of five mRNA targets in a voided urine sample in a self-contained cartridge.
This easy to use and fast solution requires less than two minutes of hands-on time with a total turnaround time of approximately 90 minutes, providing actionable results in real-time.
It can increase the negative predictive value of cystoscopy,which could inform the surveillance intervals between cystoscopies.
The non-invasive nature of the test could help to improve the monitoring compliance rate in patients with bladder cancer.
The test can easily be performed by technical staff or nurses, therefore freeing up the precious and costly time of the doctor.

(8) Schmitz-Drager et al. Considerations on the use of urine markers in the management of patients with low-/intermediate-risk non-muscle invasive bladder cancer. Urol Oncol. 2014;32(7):1061–8.;
(9) Kamat et al. Considerations on the use of urine markers in the management of patients with high-grade non-muscle-invasive bladder cancer. Urol Oncol.2014;32(7):1069–77.