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Xpert® Bladder Cancer Monitor

Order & Support
Bladder Cancer computer generated depiction.
Qualitative monitoring for recurrence in patients previously diagnosed with bladder cancer in around 90 minutes

The Need

An ill woman listens to a physician.
  • After initial diagnosis, the early detection of recurrence is crucial for successful management of bladder cancer patients1,2
  • Due to high recurrence rates, frequent follow up by cystoscopy, urine cytology and other methods are required for many years3,4
  • 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 infections5,65,6
  • Better, non-invasive, and painless methods for monitoring of bladder cancer are needed5-7
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

A male and a female researchers scanning cepheid test cartridges.
  • 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 studies8,9,12,13
  • Using voided urine, the test is easy to perform within 90-minutes and uses self-contained cartridges and an automated system8-10
  • 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 smiling female doctor attends an elderly woman.
  • 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.

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