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Efficacy of Cxbladder® test

Peer reviewed scientific publication confirms efficacy of Cxbladder® test


The prestigious American Journal of Urology has published further evidence that confirms the effectiveness of Pacific Edge’s Cxbladder® test for detecting bladder cancer.

The peer reviewed scientific paper has been published by the Journal online ahead of publication in the September print edition, which circulates to an estimated 18,000 members of the American Urological Association and other urologists around the world.

Specifically the paper, “A Multigene Urine Test for the Detection and Stratification of Bladder Cancer in Patients Presenting with Hematuria” (O’Sullivan et al)* found that the simple-to-use, non-invasive Cxbladder® test has the ability to detect nearly all tumours of concern to urologists. The findings in the paper, written by scientific and medical specialists, are based on an international, multicentre clinical study involving 485 patients in Australasia who presented with hematuria (blood in urine – an indication of possible bladder cancer).

The research team analysed the results of initial testing undertaken by cystoscopy (physical inspection of the urinary tract and bladder), cytology (urine analysis), uRNA® (a forerunner of Cxbladder®) and NMP22®. The results cited in the scientific publication compare Cxbladder® with these other commonly used bladder cancer detection tests.

Follow-up tests, 12 months later, on patients who had tested negative as a result of the benchmark cystoscopy inspection but positive by Cxbladder® also revealed that three of the patients had tumours, two of which were in an advanced state and likely to have been present for some time. This ability of Cxbladder® to identify these individuals provides a strong back up for clinicians. The paper concludes that the performance of Cxbladder® challenges the current clinical practice of the use of cytology as the routine adjunct to cystoscopy and that Cxbladder® can be used to prioritise primary care patients for cystoscopy.

Pacific Edge’s Chief Executive Officer David Darling says publication of a peer-reviewed scientific research paper in the Journal of Urology confirming the performance of Cxbladder® is a significant milestone for the acceptance of Cxbladder® by clinicians globally.

“The United States, the largest healthcare market in the world, is the most important market for Pacific Edge in its global roll-out of Cxbladder®. The Journal Of Urology is widely read by urologists, medical insurers and often those bladder cancer patients who are looking for an accurate, more convenient and less intrusive method of detecting bladder cancer. ”

Cxbladder® will be formally launched in the USA early next year following CLIA (Clinical Laboratory Improvements Amendment) certification of the purpose built testing laboratory now being completed by Pacific Edge Diagnostics USA in Hershey, Pennsylvania.

“Cxbladder® turns 10 years of research and development into an accurate easy-to-use urine test that will transform bladder cancer detection by clinicians and ease the discomfort of thousands of people who present to their doctors with hematuria.”

Cxbladder® is attracting keen interest amongst general practitioners, GP’s, in New Zealand and Australia following attendance at specialist conventions and regional medical conferences in Australia and New Zealand by both Pacific Edge and its Australian licensee, Healthscope. These conferences have increased the overall awareness of the test to both clinicians and physicians.

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