Xpert® Bladder Cancer Monitor

Home / Tests / Oncology & Human Genetics

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

Test pack size(s)

10 Tests

GXBLAD-CM-CE-10

Qty

Unit price

Subtotal

USD

Collection devices

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

GXUTR-CE-30

Qty

Unit price

Subtotal

USD

Total

Error adding items to cart. If this error persists, please contact Digital Support

List name

Label

Having trouble? Contact Cepheid Digital Support

The Need

After initial diagnosis, the early detection of recurrence is crucial for successful management of bladder cancer patients^1,2
Due to high recurrence rates, frequent follow up by cystoscopy, urine cytology and other methods are required for many years^3,4
Unfortunately, cystoscopy often misses Carcinoma in Situ (CIS) cases and sometimes also misses papillary tumors⁵
After invasive cystoscopy procedures, many patients experience pain, bleeding, and infections5,6^5,6
Better, non-invasive, and painless methods for monitoring of bladder cancer are needed^5-7

1 Campi R et al. Unmet Clinical Needs and Future Perspectives in Non–muscle-invasive Bladder Cancer. Eur Urol Focus. 2018 Jul;4(4):472-4.
2 Su H et al. Hope and challenge: Precision medicine in bladder cancer. Cancer Med. 2019;8:1806–1816.
3 Leal J et al. Economic Burden of Bladder Cancer Across the European Union. Eur Urol 2016. (Mar), 69(3), 438–447.
4 Rink M et al. The current role of circulating biomarkers in non-muscle invasive bladder cancer. Transl Androl Urol 2019;8(1):61-75l.
5 Todenhöfer T et al. Prognostic relevance of positive urine markers in patients with negative cystoscopy during surveillance of bladder cancer. BMC Cancer. 2015 Mar 19;15:155. 15:155.
6 Su H et al. Hope and challenge: Precision medicine in bladder cancer. Cancer Med. 2019;8:1806–1816.
7 Miyake M et al. Emerging biomarkers for the diagnosis and monitoring of urothelial carcinoma. Res Rep Urol 2018:10 251–261

The Solution

Xpert® Bladder Cancer Monitor is a non-invasive biomarker test for monitoring NMIBC patients for recurrence in conjunction with other clinical measures
After testing hundreds of known tumor markers, the five strongest bladder cancer indicator mRNAs were identified and selected
Xpert Bladder Cancer Monitor is a non-invasive biomarker test with proven clinical sensitivity and specificity for low and high-grade bladder cancer.
The resulting assay has been extensively validated for bladder cancer monitoring in independent studies^8,9,12,13
Using voided urine, the test is easy to perform within 90-minutes and uses self-contained cartridges and an automated system^8-10
The assay was developed to have high sensitivity and a high negative predictive value, especially for aggressive high-grade tumors
The test can be performed in any size urology lab and does not require a traditional PCR lab set up.
Every cartridge contains three controls for reliable results
Samples are stable for up to 7 days in Xpert® Urine Transport Reagent at 2–28 °C¹⁰
External controls* are available¹¹

8 Wallace E et al. Development of a 90-Minute Integrated Noninvasive Urinary Assay for Bladder Cancer Detection. J Urol 2018 Mar;199(3):655-662.
9 Van Valenberg, FJP et al. Prospective Validation of an mRNA-based Urine Test for Surveillance of Patients with Bladder Cancer. Eur Urol 2019;75:853-60.
10 Xpert® Bladder Cancer Monitor Package Insert 301-5933, Rev. E Sep 2021
11 Controls can be ordered at Maine Molecular Quality Controls http://www.mmqci.com/products/c104.html
12 D’Elia C et al. Diagnostic predictive value of Xpert Bladder Cancer Monitor in the follow-up of patients affected by nonmuscle invasive bladder cancer. J Clin Pathol 2018;0:1–5.
13 Pichler R et al. Increased accuracy of a novel mRNA-based urine test for bladder cancer surveillance. BJU Int. 2018 Jan;121(1):29-37

The Impact

A non-invasive bladder cancer test can reduce patients’ anxiety and pain⁶
Non-invasive monitoring tests can complement traditional methods and might help some patients avoid invasive procedures⁷
Reducing anxiety for patients about testing discomfort can improve monitoring compliance and ensure early detection of bladder cancer recurrence¹⁴
Aggressive high-grade tumors can be ruled out with high certainty due to the high negative predictive value,reassuring patients and their doctors
90 min time-to-result facilitates patient management

6 Su H et al. Hope and challenge: Precision medicine in bladder cancer. Cancer Med. 2019;8:1806–1816.
7 Miyake M et al. Emerging biomarkers for the diagnosis and monitoring of urothelial carcinoma. Res Rep Urol 2018:10 251–261
14 Biardeau X, et al.Prospective evaluation of anxiety, pain, and embarrassment associated with cystoscopy and urodynamic testing in clinical practice. Can Urol Assoc J.2017 Mar-Apr; 11(3-4): 104–110.