PEB
25/05/2015 09:08
GENERAL
NOT PRICE SENSITIVE
REL: 0908 HRS Pacific Edge Limited
GENERAL: PEB: Cxbladder Detect Outperforms Other Non-Invasive Diagnostics
Research Shows Pacific Edge's Cxbladder Detect Outperforms Other
Non-Invasive Bladder Cancer Diagnostics
Dunedin, NZ and Hershey, PA (May 25, 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. http://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(R) 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(R) 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 laboroatory 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.
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, 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.
www.pacificedge.co.nz www.pacificedgedx.com
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
End CA:00264743 For:PEB Type:GENERAL Time:2015-05-25 09:08:24
