The Cxbladder suite of products addresses multiple needs across the entire diagnostic, treatment and management pathway for bladder cancer. Our tests are being deployed in a wide variety of clinical settings in multiple markets. Find out more about the clinical application of each test below:
Last Updated: 26 Aug 2021 05:11 pm
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Cxbladder Triage
A non-invasive and highly sensitive test to help rule out the presence of bladder cancer at an early stage, Cxbladder Triage is a rapid and reliable way to give you and your patient’s peace of mind.
When to use the test?
Cxbladder Triage is an early stage tool designed to be used by healthcare professionals to assist them in ruling out bladder cancer. Cxbladder Triage is particularly appropriate for identifying low risk patients presenting with hematuria.2
Who should use the test?
Cxbladder Triage is for use on low risk patients presenting with hematuria to identify those who have a low probability of having UC, for whom a more extensive evaluation may not be required. This may include patients with microhematuria, young patients and non-smokers, or those who may not tolerate cystoscopy for medical or religious reasons.
How does the test work?
Cxbladder Triage is an innovative test that combines known bladder cancer risk factors with molecular diagnostics to calculate a segregation index that may help rule out bladder cancer, or recommend a Standard Clinical Workup.
What will the test result tell me?
The Cxbladder Triage algorithm calculates a score between 0 and 10, and using a cut-off of 4.0, identifies patients who have a low probability of having UC.
What is the performance of the test?
Cxbladder Triage has an overall sensitivity of 95.1% and an observed NPV of 98.5% with a test negative rate of 40%.
What is required to perform the test?
Cxbladder Triage requires a single urine sample from the patient, in addition to patient clinical information.
How long will it take to receive results?
Cxbladder Triage results will be available within seven working days.
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Cxbladder Detect
Cxbladder Detect is a clinically proven, non-invasive test for assessing the probability of bladder cancer in your patients, giving you reliable results that can make a meaningful difference in their treatment.
When to use the test?
Cxbladder Detect is a test to be used by healthcare professionals within a urological evaluation for UC and as an adjunct to cystoscopy. Cxbladder Detect may also be used to replace other urine-based tests.1
Who should use the test?
Cxbladder Detect is for use on high risk patients presenting with hematuria, such as those with gross hematuria, to assist the clinician in the diagnostic evaluation, alongside cystoscopy and other procedures and tests.
How does the test work?
Cxbladder Detect is a molecular diagnostic test that measures the presence of five biomarker genes that have been identified to be at elevated levels in patients with bladder cancer.3
What will the test result tell me?
Cxbladder Detect delivers a composite gene expression score between 0 and 1.
A score greater than 0 and less than 0.12 is NORMAL.
A score greater than or equal to 0.12 and less than 0.23 is ELEVATED - meaning a low probability of UC, but representing a change in biomarker patterns that requires further investigation.
A score greater than or equal to 0.23 is a HIGH gene expression score, indicating a high probability of UC.What is the performance of the test?
Cxbladder Detect has an overall sensitivity of 82% using the lower (0.12 cut-off).1
A gene expression score of less than 0.12 (a NORMAL result), has an NPV of 97%
A score of 0.12 or greater, and less than 0.23 (an ELEVATED result) has an NPV of 94%.
A score greater than or equal to 0.23 (a HIGH result) has a PPV of 68%.What is required to perform the test?
Cxbladder Detect requires a single urine sample from the patient.
How long will it take to receive results?
Cxbladder Detect results will be available in five working days
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Cxbladder Monitor
Cxbladder Monitor is an accurate and highly sensitive urine-based laboratory test to find the probability of disease recurrence. It reduces the need for regular cystoscopy or other expensive, invasive procedures in many patients with a history of urothelial carcinoma (UC).1
When to use the test?
Cxbladder Monitor is an accurate and highly sensitive urine-based laboratory test to determine the probability of disease recurrence. It reduces the need for regular cystoscopy or other expensive, invasive procedures in many patients with a history of urothelial carcinoma (UC).1
Who should use the test?
Cxbladder Monitor is for use when assessing patients for recurrent bladder cancer or UC.1
How does the test work?
Cxbladder Monitor delivers a combined segregation score (or index) calculated from five genotypic biomarkers in the urine, and from clinical information about previous bladder cancer or UC1
What will the test result tell me?
Cxbladder Monitor accurately shows when recurrent bladder cancer or UC is UNLIKELY. It indicates a low probability of recurrent bladder cancer or UC, and patients for whom regular cystoscopy may not be required1
What is the performance of the test?
Cxbladder Monitor has an overall sensitivity of 93% and an observed NPV of 97%.
What is required to perform the test?
Cxbladder Monitor requires a single urine sample from the patient.
How long will it take to receive results?
Cxbladder Monitor results will be available in five working days.
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References
1 Lotan Y, Hershey JR, Shariat S, et al. The development and clinical validation of a high sensitivity urine biomarker test for the determination of recurrence in urothelial carcinoma patients. American Urological Association Annual Meeting 2016; San Diego, CA, USA. Read abstract
2 O'Sullivan et al: A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria, J Urol 2012; 188: 741-747
3 Kavalieris et al: A segregation index combining phenotypic (clinical characteristics) and genotypic (gene expression) biomarkers from a urine sample to triage out patients presenting with hematuria who have a low probability of urothelial carcinoma. BMC Urology 2015; 15:23 Read article
4 Holyoake et al: Development of a multiplex RNA urine test for the detection and stratification of transitional cell carcinoma of the bladder, Clin Cancer Res 2008; 14(3): 742-749
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).
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