David Darling, Pacific Edge Ltd.

Recently published study results concluded that Cxbladder Detect, a molecular diagnostic for the noninvasive detection of bladder and other urinary tract cancers, outperforms other noninvasive bladder cancer diagnostics.

Published May 12 in the peer-reviewed open access medical journal BioMed Central Medical Research Methodology, the study compared and ranked four widely used noninvasive tests for bladder cancer. “All data analyzed, pre-and post-imputation, showed that Cxbladder Detect had higher signal-to-noise ratio (SNR) and outperformed all other comparator tests, including fluorescence in situ hybridization (FISH),” wrote the authors.

Cxbladder Detect is produced and marketed by Pacific Edge Ltd, a New Zealand-headquartered global cancer diagnostics company with a US subsidiary, Pacific Edge Diagnostics USA, Hershey, PA.

“The published research reviewed the performance of Cxbladder Detect versus other available noninvasive test methods, based on data from 939 patients and five clinical trials, and showed Cxbladder Detect to outperform those methods, including the UroVysion FISH assay that is widely used in the United States in conjunction with standard procedures in the urological work-up for bladder cancer,” says David Darling, CEO of Pacific Edge. The other noninvasive test methods included in the comparison were cytology and NMP22.

Among all types of cancer globally, bladder cancer has the ninth highest incidence rate—and the fourth highest incidence rate for men. One of the early symptoms of bladder cancer is the presence of blood in the urine, haematuria. People with haematuria often present to their general practitioner before being referred to a urologist.


Jackie Walker, Pacific Edge Diagnostics USA.

Bladder cancer has a very high recurrence rate of approximately 50% to 70%, with up to 30% of these recurring as later stage tumors. However, bladder cancers are highly treatable, especially if detected in the early stages when there is a much higher probability of survival. Timely detection and regular surveillance and monitoring of this cancer is a key element of the clinical process and of the individual’s annual healthcare plan.

“These new findings favorably position Cxbladder Detect as the leading noninvasive bladder cancer diagnostic tool in terms of its relative performance (high sensitivity, high signal-to-noise, and low cross-validation error rate),” says Darling.

“These results should be highly relevant for both urologists and US payer organizations who provide reimbursement for cancer diagnostic tests,” says Jackie Walker, CEO of Pacific Edge Diagnostics USA. “This publication is the first piece of comparative data that includes UroVysion FISH, a molecular test that is widely used by clinicians and physicians in the US and reimbursed by most major payors.”

Cxbladder Detect

Cxbladder Detect test kit.

Cxbladder Detect is a proprietary molecular diagnostic that detects bladder and other urinary tract cancers from a small volume of urine. The test is commercially available in Australia, and is available in New Zealand and the United States as a laboratory-developed test (LDT) performed at the company’s CLIA-certified laboratories. Validated by a multicenter international clinical study, Cxbladder Detect provides clinicians with a quick and accurate measure of the presence of the cancer, and provides urologists with a reliable adjunct to cystoscopy.

“This and other recent peer-reviewed publications demonstrating the superiority of Cxbladder represent key elements in our company’s strategy of delivering physicians a one-stop shop for bladder cancer detection, with high-performance Cxbladder products in conjunction with standard procedures for bladder cancer detection and surveillance,” says Darling.

For further information, visit Pacific Edge Diagnostics USA.


  1. Breen V, Kasabov N, Kamat AM, et al. A holistic comparative analysis of diagnostic tests for urothelial carcinoma: a study of Cxbladder Detect, UroVysion FISH, NMP22, and cytology based on imputation of multiple datasets. BioMed Central Medical Research Methodology. 2015; 15:45; doi: 10.1186/s12874-015-0036-8. Available at: www.biomedcentral.com/1471-2288/15/45. Accessed June 10, 2015.