||November 13, 2017
||November 13, 2017
Cxbladder is a family of non-invasive urinary biomarker tests manufactured by Pacific Edge Diagnostics. Cxbladder was developed as an alternative or adjunct to conventional tests for the initial diagnosis of bladder cancer or for later disease recurrence. The following tests are included in the Cxbladder family:
- Cxbladder Triage: Used to rule out bladder cancer at an early stage.
- Cxbladder Detect: Used to assess the probability of bladder cancer.
- Cxbladder Monitor: Used to assess the probability of disease recurrence.
- Cxbladder Resolve: Used to identify patients with high grade or late stage bladder cancer.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
|Policy Position Coverage is subject to the specific terms of the member’s benefit plan.|
Cxbladder is considered experimental/investigational and therefore non-covered.
- Experimental/investigational molecular and genomic (MolGen) tests refer to assays involving chromosomes, DNA, RNA, or gene products that have insufficient data to determine the net health impact, which typically means there is insufficient data to support that a test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinical utility), and/or performs better than an existing standard of care medical management option. Such tests are also not generally accepted as standard of care in the evaluation or management of a particular condition.
- In the case of MolGen testing, FDA clearance is not a reliable standard given the number of laboratory developed tests that currently fall outside of FDA oversight and FDA clearance often does not assess clinical utility.
|Professional Statements and Societal Positions|
Guidelines and Evidence
The National Comprehensive Cancer Network (NCCN, 2017) Clinical Practice Guidelines do not specifically comment on the Cxbladder tests. However, the guidelines state the following regarding the use of other available urinary biomarkers:
- “Management of bladder cancer is based on the pathologic findings of the biopsy specimen, with attention to histology, grade, and depth of invasion. These factors are used to estimate the probability of recurrence and progression to a more advanced stage. Consideration may be given to FDA-approved urinary biomarker testing by fluorescence in situ hybridization or nuclear matrix protein 22 in monitoring for recurrence.”
In 2011, the U.S. Preventive Services Task Force updated its 2004 evidence review with regard to bladder cancer screening, and reported the following:
- “No study evaluated the sensitivity or specificity of tests for hematuria, urinary cytology, or other urinary biomarkers for bladder cancer in asymptomatic persons without a history of bladder cancer. The positive predictive value of screening is less than 10% in asymptomatic persons, including higher-risk populations. No study evaluated harms associated with treatment of screen-detected bladder cancer compared with no treatment.”
- “Screening tests that might be feasible for primary care include tests for hematuria, urinary cytology, and other urinary biomarkers. The U.S. Preventive Services Task Force (USPSTF) last reviewed the evidence on bladder cancer screening in 2004 but found insufficient evidence to guide a recommendation.”
The diagnostic accuracy of Cxbladder has been compared with standard diagnostic methods in individuals suspected of urothelial cancer due to gross hematuria in the urine.
- According to Chou et al. (2015), the diagnostic accuracy study carries a medium risk of bias and reported sensitivity of the Cxbladder text of 82% (95% CI, 70% to 90%) and specificity of 85% (95% CI, 81% to 88%).
There are available studies that evaluated the effects of on patient-relevant outcomes (survival, quality of life) of using the Cxbladder test (clinical utility).
- Additional research is needed to assess how Cxbladder testing will be used in the disease management of patients with cancer. Questions persist regarding if Cxbladder has sufficient clinical utility to replace invasive cystoscopy or if Cxbladder has the potential to augment or clarify uncertain results obtained using conventional diagnostic methods.
Ongoing clinical trials
- The Cxbladder Monitoring Study: A Clinical, Non-Intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC).
- Primary Outcome Measures:
- “Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.”
- “The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients with recurrent disease.”
- “Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively.”
|Place of Service: Inpatient/Outpatient|
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Cxbladder is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
|The policy position applies to all commercial lines of business|
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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