Pacific Edge's Cxbladder Triage™ Accurately Stratifies Patients with Bladder Cancer Symptoms but Low Probability of Bladder Cancer

DUNEDIN, New Zealand and HERSHEY, Pa., May 19, 2015 /PRNewswire/ -- Cxbladder Triage™, a urine-based molecular diagnostic from Pacific Edge Ltd., combines clinical risk factors and gene expression biomarkers to accurately triage patients presenting with blood in their urine (hematuria) who have a low probability of urothelial cancer (UC, bladder cancer), according to research published in BMC Urology. The new test offers the potential for physicians to reduce the number of patients with hematuria requiring a full urological evaluation for UC, thus helping to maintain patient quality of life and reducing diagnosis-related health care costs.

Hematuria can be symptomatic of UC and ruling out patients with benign causes of such bleeding during primary evaluation is challenging. Under current guidelines, patients with hematuria must typically undergo a full urological workup to investigate the possibility of bladder cancer, with a corresponding increase in the overall clinical and financial burden of these patients on health care systems. Furthermore, standard diagnostic methods are often inconclusive and many of the test methods are invasive or result in high radiation exposures that can have a detrimental effect on patient quality of life.

"This research shows that Cxbladder Triage can accurately identify those patients who have a low probability of UC with a high level of sensitivity (95%) and high negative predictive value NPV (98%)," said David Darling, Chief Executive Officer of Pacific Edge. "The use of this test will enable physicians to evaluate those patients presenting with hematuria, and quickly and accurately remove those with a low probability of cancer, thereby reducing the number of individuals who require an expensive and invasive full urological workup. The use of Cxbladder Triage will also allow clinicians to make effective choices about the deployment of their skills and capabilities on the patients who need it most."

"We launched Cxbladder Triage in New Zealand at the end of 2014, and will be working diligently to bring this new test to other markets as part of our vision for the suite of Cxbladder products becoming a 'one-stop shop' for bladder detection and management," he concluded.

"Cxbladder Triage is the second product in Pacific Edge's suite of proprietary molecular tests for the detection and management of bladder cancer and it complements our UC detection test, Cxbladder Detect," said (Ms.) Jackie Walker, Chief Executive Officer for Pacific Edge Diagnostics USA. "Cxbladder Triage provides a non-invasive, Laboratory Developed Test (LDT) that offers the potential for physicians to quickly, easily and painlessly rule out the presence of bladder cancer, giving greater peace of mind to both patients and clinicians. It is expected that Cxbladder Triage will be available for use by US physicians this year."

ABOUT Cxbladder Triage
Cxbladder Triage is a novel molecular test that combines the power of the genomic biomarkers with extra phenotypic and clinical risk factors to accurately identify and remove patients with hematuria who have a low probability of bladder cancer, from needing to have a full-urological work-up. This is a tool for use by clinicians and physicians in the primary evaluation and is intended to reduce of the number of patients needing an expensive and invasive work-up for urothelial cancer. www.cxbladder.com

ABOUT Cxbladder Detect
Cxbladder Detect is a proprietary, accurate molecular diagnostic test that enables the non-invasive detection of bladder and other urinary tract cancers from a small volume of urine. Cxbladder Detect is commercially available in New Zealand, Australia and the USA.  Cxbladder Detect is available in the USA and NZ as a laboratory Developed Test (LDT) from the company's CLIA certified laboratories, providing physicians and clinicians with a quick, cost effective and accurate measure of the presence of the cancer, and provides urologists with an effective adjunct to cystoscopy. The Cxbladder Detect cancer detection test has been validated by a multicentre, international clinical study.  www.cxbladder.com

ABOUT Bladder Cancer
Globally, bladder cancer has the 9th highest incidence and the 4th highest incidence for men. One of the early symptoms of bladder cancer is the presence of blood in the urine, hematuria. People with hematuria often present to their general practitioner before being referred on to a urologist. Bladder cancer has a very high recurrence rate of approximately 50%-70% with up to 30% of these recurring as later stage tumours. 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.

ABOUT PACIFIC EDGE 
Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic company specialising in the discovery and commercialisation of diagnostic and prognostic technology for the early detection and monitoring of cancer. The company is developing and commercialising its range of Cxbladder bladder cancer tests. It's first commercial product, Cxbladder Detect, is now being actively marketed to physicians and clinicians in New Zealand, Australia, and the USA through the company's wholly owned subsidiaries and selected commercial partners. www.pacificedge.co.nz   www.pacificedgedx.com

For more information contact:

David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800

US Media Contact:

Joan E. Kureczka
Kureczka/Martin Associates
Joan at Kureczka-Martin.com
P: +1 (415) 821 2413

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SOURCE Pacific Edge Limited

Related Links

http://www.pacificedge.co.nz