DUNEDIN, NEW ZEALAND and HERSHEY, PA USA (Press Release) - May 26, 2015 - Newly published research demonstrates that Cxbladder out performs other non-invasive bladder cancer diagnostics, announced Pacific Edge, Ltd. The new research comparing and ranking four widely used tests was published online this week in the peer-reviewed Open Access medical journal BioMed Central (“BMC”) Medical Research Methodology (www.biomedcentral.com/1471-2288/15/45). Pacific Edge, a New Zealand-headquartered global cancer diagnostics company with U.S. subsidiary, Pacific Edge Diagnostics USA, in Hershey, PA, developed and markets Cxbladder.
“The published research reviewed the performance of Cxbladder Detect versus other available non-invasive test methods, based on data from 939 patients and 5 clinical trials, and showed Cxbladder Detect to outperform those methods, including the UroVysion® FISH assay that is widely used in the United States in conjunction with standard procedures in the urlogical work-up for bladder cancer,” said David Darling, Pacific Edge Chief Executive Officer. “These new findings favourably position Cxbladder Detect as the leading non-invasive bladder cancer diagnostic tool in terms of its relative performance (high sensitivity, high signal-to-noise, and low cross-validation error rate).” The other non-invasive test methods included in the comparison were cytology and NMP22.
(Ms.) Jackie Walker, Chief Executive Officer for Pacific Edge Diagnostics USA, said, “These results should be highly relevant for both urologists and US payer organizations who provide reimbursement for cancer diagnostic tests. This publication is the first piece of comparative data that includes UroVysion® FISH, a molecular test that is widely used by clinicians and physicians in the US and reimbursed by most major payers.”
“This and other recent peer-reviewed publications demonstrating the superiority of Cxbladder represent key elements in our company’s strategy of delivering physicians a one-stop shop for bladder cancer detection with high performance Cxbladder products in conjunction with standard procedures for bladder cancer detection and surveillance,” concluded David Darling.
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 a reliable adjunct to cystoscopy. The Cxbladder Detect cancer detection test has been validated by a multicentre, international clinical study (www.Cxbladder.com).
ABOUT Cxbladder Triage
Cxbladder Triage is a novel molecular test that combines the power of the genomic biomarkers with extra phenotypic biomarkers to accurately identify and remove patients with haematuria 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 a full expensive and invasive work-up for urothelial cancer.
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, haematuria. People with haematuria 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.
[ PRESS RELEASE ]