Greater Confidence in the Rule Out of Urothelial Cancer.

Cxbladder is a suite of genomic urine tests optimized for the rule-out and surveillance of urothelial cancer in patients presenting with microhematuria and those being monitored for recurrent disease. The tests help you prioritize your time and clinical resources, optimize your practice workflow, and improve the overall patient experience.

• Enables reliable risk stratification. Safely de-intensifies clinical workup in low risk patients, while prioritizing higher risk patients for immediate care. 
• Helps resolve atypical cytology and equivocal cystoscopy.
• Offers a non-invasive surveillance alternative that can reduce the burden of repeated cystoscopy in those with a low risk of recurrence, improving comfort and compliance.

Cxbladder works at a molecular level, analyzing five biomarker genes to help rule out urothelial carcinoma.

• Objective and reliable: Exceptional performance and clinically actionable results. 
• Clinically proven: Proven performance in over 20 peer-reviewed publications for primary detection and surveillance. Cxbladder has been used by over 4,400 urologists in more than 100,000 patients.
• Covered by Medicare
• Easy-to-use: Cxbladder’s unique urine sample collection system is non-invasive and easy for both clinical teams and patients to use.
• In-home sampling: To streamline patient care we are now offering an in-home sampling service to both hematuria and surveillance patients.
• Quick: Upon receiving a urine sample, our certified US laboratory will provide actionable results in 7-10 business days.

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A Suite of Tests Optimized for Hematuria Evaluation and Surveillance

 

Hematuria Evaluation

Cxbladder Triage

Cxbladder Triage is a diagnostic test optimized for primary care. With high NPV, the test helps to de-intensify clinical work-up in microhematuria patients with a low probability of urothelial cancer, reducing the need for referral and invasive procedures, while prioritizing those who require further investigation.

• Analyzes gene expression alongside information on known UC risk factors like age, gender and smoking history to help rule out hematuria patients with a low risk of disease, while prioritizing those who require further investigation.
• Supports a new model for clinical practice and resource utilization. This deployment model provides care to the greatest number of patients and offers clinically actionable information at the earliest point in the patient care pathway.

Featured study: STRATA

Our STRATA study, demonstrating Cxbladder Triage can safely and more effectively risk-stratify low risk hematuria patients compared to American Urological Association (AUA) guidelines, has now been published in the Journal of Urology. STRATA is the first ever randomized controlled trial of a urine biomarker for hematuria evaluation.

Cxbladder Detect

Cxbladder Detect is designed to improve practice workflow and efficiency, while giving patients the best experience possible. The test is optimized for the rule out of urothelial cancer in patients presenting with microhematuria.

• Enables reliable risk stratification. Safely de-intensifies clinical workup in low-risk patients, while prioritizing higher risk patients for immediate care.
• Spares low risk patients the discomfort, anxiety and risks of an invasive procedure.
• Helps resolve diagnostic dilemmas like atypical cytology and equivocal cystoscopy.

Cxbladder Detect⁺

Cxbladder Detect⁺ is a second generation Cxbladder test that combines an analysis of 5 core mRNA biomarkers with DNA markers to provide enhanced clinical utility. Detect+ extends best in class performance, increasing the rate of UC rule out in patients presenting with microhematuria.

Please note that Detect+ is not covered by Medicare

 

Bladder Cancer Surveillance

Cxbladder Monitor

Cxbladder Monitor is a non-invasive surveillance alternative that can reduce the burden of repeated cystoscopy in non-muscle invasive bladder cancer patients with a low risk of recurrence, improving patient comfort and compliance.

• In suitable cases post TURBT (> 9 months), can alternate with cystoscopy to de-intensify surveillance.
• May be used to replace cystoscopy in patients with no recurrence long term (low risk 3+ years, high risk 5+ years) after shared decision making with the patient.
• Option of in-home sampling reduces the travel burden on patients.

Contact Us to Learn More About the Cxbladder Suite

 

Featured Videos: 

UroToday: Bridging the Gap in Microhematuria Evaluation: A Discussion on the STRATA Trial. Click here to view.

Grands Rounds in Urology: Use of the Cxbladder Monitor Genomic Urine  Test for Surveillance of Patients with Non-Muscle-Invasive Bladder Cancer. Click here to view.

 

UroToday: From Science to Clinical Utility

• Cxbladder Detect - Bladder Cancer Detection for Patients Who Present with Hematuria: View
• Cxbladder Monitor - Bladder Cancer Surveillance for Patients with Urothelial Carcinoma: View 

 

 

Cxbladder In-Home Sampling is Available

Cxbladder’s unique urine sampling system is non-invasive and easy-to-use. The process is quick and painless, taking only minutes.

To simplify and streamline the bladder cancer testing process, we are now offering the Cxbladder In-Home Sampling Program for surveillance patients and those presenting with hematuria across the US. Participating patients have the option of submitting their urine sample in the comfort of their own home without the need to physically visit their Urologist.
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Cxbladder is Covered by Medicare

We’re pleased to confirm that Cxbladder is currently covered by Medicare. For questions about coverage please call the Cxbladder Assist Team at 1-855-CXBLADR (1-855-292-5237, option 1).

Contact Us to Request More Information on Cxbladder

 

Last Updated: 22 Oct 2024 06:07 am

• References

  Pacific Edge is responsible for the development and determination of the performance characteristics for Cxbladder. Because Cxbladder is a Laboratory Developed Test (LDT), Cxbladder has not been cleared or approved by the US Food and Drug Administration (FDA).