Peer reviewed scientific publication confirms 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, "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.

"Clinicians and physicians have been quick to recognise that this is an accurate test that they can
use in their clinical routine to detect bladder cancer in patients. This will also enable these patients
to be prioritised for specialist treatment by their urologist."

* An abstract of the article can be found on the Journal of Urology's website at:


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