Peer review confirms efficacy of test

David Darling demonstrates one of the  Pacific Edge bladder cancer testing kits. Photo by Gregor...
David Darling demonstrates one of the Pacific Edge bladder cancer testing kits. Photo by Gregor Richardson.
Publication of a peer-reviewed scientific research paper confirming the performance of Pacific Edge's Cxbladder was a significant milestone for the acceptance of the bladder cancer test globally, Pacific Edge chief executive David Darling said yesterday.

The American Journal of Urology, which circulated to an estimated 18,000 members of the American Urological Association and other urologists around the world, had published further evidence that confirmed the effectiveness of Pacific Edge's Cxbladder test, he said.

Specifically, the paper found that the "simple-to-use, non-invasive Cxbladder test has the ability to detect nearly all tumours of concern to urologists".

The finding was important to Dunedin-based Pacific Edge, he said.

"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 was widely read by urologists, medical insurers and often those bladder cancer patients who were looking for an accurate, more convenient and less intrusive method of detecting bladder cancer, Dr Darling said.

The findings in the paper, written by scientific and medical specialists, were based on an international multi-centre clinical study involving 485 patients in Australia and New Zealand who presented with hematuria - blood in the urine, an indication of possible bladder cancer.

The research team analysed the results of initial testing undertaken by other methods, including cystoscopy (physical inspection of the urinary tract and bladder), and then compared the results with those from CXbladder.

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 three of the patients had tumours, two of which were in an advanced state and likely to have been present for sometime, Dr Darling said.

"The ability of Cxbladder to identify these individuals provides a strong back-up for clinicians."

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


At a glance

• Cxbladder turns 10 years of research 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 - blood in their urine.

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