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Xpert® Bladder Cancer Detection

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Bladder cancer computer generated depiction.

Detection of the presence of bladder cancer in patients with hematuria in around 90 minutes

The Need

An ill woman listens to a physician.
Early and accurate diagnosis of bladder cancer is critical in patients with hematuria.3
  • Four out of five people with bladder cancer have blood in their urine4
  • But 80–90% of patients with visible hematuria, and over 95% of patients with non-visible hematuria do NOT have cancer
  • There are many known causes of hematuria including urinary tract infection, nephrolitiasis (stones), etc4
  • In patients with hematuria, it can be difficult to decide which patients might have cancer and which patients might have a different condition
  • Primary care physicians are sometimes reluctant to refer patients with visible or significant microscopic hematuria to urology for further investigation5
3 Kamat AM, et al. Bladder Cancer. Lancet. 2016 Dec 3;388(10061):2796-2810.
4 Avellino G, et al. Diagnosis and Management of hematuria. Surg Clin North Am. 2016 Jun;96(3): 503-15.
5 Yafi FA, et al. Patients with microscopic and gross hematuria: practice and referral patterns among primary care physicians in a universal health care system. Can Urol Assoc J 2011;5(2):97-101.

The Solution

A male and a female researchers scanning cepheid test cartridges.
Xpert Bladder Cancer Detection is a non-invasive biomarker test for patients with hematuria that is used in conjunction with other clinical measures.
  • Five mRNA biomarkers were validated for the detection of bladder cancer
  • The non-invasive and painless test uses voided urine samples
  • The test is performed using a self-contained cartridge and system, and can be performed in any size urology lab
  • Each cartridge contains three controls for dependable results
  • Sample stability for up to 7 days in Xpert® Urine Transport Reagent
  • The test supports on‑demand testing

The Impact

A smiling female doctor attends an elderly woman.
A test that helps clinicians gain information for patients with hematuria.
  • Non‑invasive urine‑based testing may help avoid the discomfort associated with invasive procedures6
  • A high negative predictive value provides additional information to support clinical assessment.
  • Easy to implement and train
  • A cartridge‑based" test and workflow with decentralized laboratory testing
6 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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