Dunedin-based Pacific Edge has released today the second product in its suite of diagnostic tests for the detection and management of bladder cancer.

Cxbladder Triage complements the first molecular diagnostic test Cxbladder Detect and will enable clinicians and physicians to accurately segregate patients who present with hematuria (blood in the urine), who have a low probability of having bladder cancer. Potentially this will save many patients from undergoing an expensive and invasive investigation for bladder cancer.

Hematuria can be an early symptom of urinary tract carcinomas. The incidence of these cancers is quite low,  but the established guidelines require that all patients with confirmed hematuria receive a urological work-up to establish the cause. Given the low incidence, a large number of people with hematuria will be worked-up by the urologist or physician; a process that is expensive in cost and time, and for patients causes discomfort, carries the risk of further infection and possible sexual dysfunction.

Cxbladder Triage is now available in New Zealand and will be launched in the USA early in 2015.

 Pacific Edge Chief Executive Officer David Darling says “the launch of Cxbladder Triage takes us a step closer to our vision of a ‘one-stop-shop’ for bladder cancer detection and management.”

“Cxbladder Triage will be a new weapon against cancer in the armoury of both urologists and physicians and works in a complementary way to Cxbladder Detect.  Cxbladder Triage enables urologists and physicians to evaluate patients presenting with hematuria, to quickly and accurately remove those  who have a low probability of having a urothelial carcinoma, thereby lowering the number that are likely to need a full urological work-up.”

In New Zealand, Cxbladder Triage is targeted to empower general practitioners (GPs), or any physician evaluating patients with hematuria in the primary care setting.

“Cxbladder Triage is a non-invasive laboratory test used primarily to rule out the presence of bladder cancer quickly, easily and painlessly, giving greater peace of mind to both clinicians and their patients. In some cases, the results from the Cxbladder Triage test will indicate a need for more extensive testing.”

In the United States, the American Urology Association (AUA) is urging patients identified as having very low levels of blood in their urine to undergo more extensive testing as research shows that, other than the lower incidence of cancer, there is little difference in the nature of bladder cancer between those presenting with macro (visible blood) and micro (microscopic traces of blood) hematuria. This change in the clinical guidelines for patients with micro hematuria is expected to result in a considerable increase in the number of patients who are required to have this expensive urological work-up for the presence of carcinomas in the urinary tract.

Pacific Edge Diagnostics NZ Limited Commercial Director, Brent Pownall, says the recommendations of the AUA, if adopted by other countries including New Zealand, will have significant implications for resource allocation within the healthcare system.

“The ease of use of the Cxbladder system and its ability to provide laboratory results from a small sample of urine in a few working days offers immediate benefits to patients. Equally important, it encourages healthcare providers to evaluate patients quickly within the community setting, and allow hospital and specialist clinic resources to be focussed only on those patients who require higher level intervention.”

 “Cxbladder Triage is the first of its kind in this market,  combining known bladder cancer risk factors with molecular diagnostics to rule out bladder cancer with confidence.”

Many clinicians in New Zealand are already familiar with Cxbladder and its ability to detect nearly all urinary tract tumours of significance. Those who have been treated for bladder cancer and have to undergo regular testing for its reoccurrence have been using Cxbladder Detect by ordering through the Cxbladder website. Others have chosen to initiate the tests themselves. Regardless of how the Cxbladder testing service is initiated, results are sent only to patients’ nominated clinicians.

In the USA, the Southern California Permanente Medical Group (SCPMG) will undertake a 2000 patient evaluation  of Cxbladder Triage in their specific clinical settings to determine its efficiency and effectiveness. The SCPMG is part of Kaiser Permanente, which is one of the largest integrated healthcare providers in the USA with more than 9 million registered clients.