PEB
08/12/2014 13:31
GENERAL
PRICE SENSITIVE
REL: 1331 HRS Pacific Edge Limited
GENERAL: PEB: Pacific Edge launches Cxbladder Triage
8th December 2014
Pacific Edge launches Cxbladder Triage
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 haematuria (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.
Haematuria 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 haematuria receive a urological work-up to
establish the cause. Given the low incidence, a large number of people with
haematuria 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 haematuria, 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 haematuria 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) haematuria. This change in the clinical
guidelines for patients with micro haematuria 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.
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
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
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 the opportunity to reduce their reliance on the need
for invasive tests such as 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 bladde
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 will result
in a reduction of the number of patients needing an 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.
End CA:00258630 For:PEB Type:GENERAL Time:2014-12-08 13:31:59
