Ann: GENERAL: PEB: BOP & Lakes Urologists adopt C

• Release Date: 11/02/14 14:35
• Summary: GENERAL: PEB: BOP & Lakes Urologists adopt Cxbladder
• Price Sensitive: No
• Download Document  8.68KB

					PEB
11/02/2014 12:35
GENERAL

REL: 1235 HRS Pacific Edge Limited

GENERAL: PEB: BOP & Lakes Urologists adopt Cxbladder

11 February 2014

BOP and Lakes Urologists adopt Cxbladder

Patients presenting with symptoms of bladder cancer and those under
surveillance of bladder cancer in the Bay of Plenty and Lakes District Health
Board regions will now be evaluated as part of their clinical program, with
Pacific Edge's non-invasive urine sampling Cxbladderdetect test.

Bay of Plenty and Lakes District urologists are the latest to join the list
of New Zealand clinicians and DHB's who are being signed by Pacific edge
Diagnostics to offer their patients Cxbladderdetect. Cxbladder is a superior
technology with its ability to detect nearly 100 per cent of urinary tract
carcinomas , in preference to cytology for the detection and monitoring of
patients who may have bladder cancer.

Like MidCentral DHB, which began using Cxbladderdetect in June, BOP
urologists will use Cxbladderdetect to evaluate patients presenting with
blood in the urine (haematuria) as part of their clinical regime. This new
strategy  is expected to involve local GPs (the patient's primary point of
contact when symptoms occur) using Cxbladderdetect  to help prioritise those
patients who need to be seen urgently. They will also be able to identify low
risk patients who do not require a full clinical work-up for bladder cancer,
saving the public health system considerable associated expense, not to
mention the inconvenience to the patients. Less than one in twenty of those
patients with micro-haematuria are found to need further treatment for
bladder cancer.

Pacific Edge is a Dunedin-based cancer diagnostic company leading in the
development and commercialisation of molecular diagnostic tests. Pacific Edge
Chief Executive Officer David Darling says there are significant potential
savings to be made in the New Zealand health budget if all DHBs adopt
Cxbladderdetect for the early evaluation and further analysis of patients
presenting with haematuria.

"Many New Zealanders may have heard Sir Peter Leitch talk on television last
year about the ease of use and high degree of confidence he and his clinician
had in Cxbladderdetect
(http://tvnz.co.nz/national-news/nz-celebrity-helps-cancer-cause-video-523452
1) for monitoring his recovery from bladder cancer". Those benefits are now
being made available to nearly half a million New Zealanders [488,280 : pop
numbers from MOH website] within the BOP, Lakes regions and the Mid Central
DHB.

"Cxbladderdetect will allow clinicians in these three regions to provide
better clinical outcomes for patients referred for urological evaluation and
contribute considerable efficiencies for patients and healthcare providers,
from its use."

Bay of Plenty urologist, Mark Fraundorfer says that now is the right time to
start using Cxbladderdetect. "Pacific Edge have gathered the clinical data
and published in a peer reviewed journal, and the superior performance over
cytolgy is clear. BOP (and Lakes) urologists have used Cxbladderdetect in a
variety of clinivcal settings in both public and our private clinics over the
last nine months, confirming the performance of the technology.
Cxbladderdetect provides better information about the patients being referred
to urologists and allows us to increase our focus on the patients that need
further evaluation and treatment, and will avoid a significant number of
unnecessary procedures. This is a good outcome for both the patients and the
public health system as a whole."

A recently completed clinical user programme involving 178 patients
undertaken by Waitemata District Health Board and Urology Associates in
conjunction with Canterbury DHB has confirmed the successful results of a
multi-centre international peer reviewed study of 485 patients published in
the prestigious American Journal of Urology in September 2012. Both studies
showed that Cxbladderdetect identified correctly nearly 100 per cent of
tumours of concern to clinicians, including those that cytology and several
that cystoscopy did not identify.  The results of the two centre New Zealand
user programme are expected to be formally published later this year.

For clinicians and DHBs focused on providing the very best cost effective
healthcare for New Zealanders, Cxbladderdetect provides a number of
significant advantages that have the potential to change clinical practice
and lower the overall cost of managing the patient's disease:

o The Cxbladderdetect Urine Sampling System (USS) can be sent directly
to the patient at home or to their GP clinic, thereby reducing waiting times
to see a specialist within the public hospital system.

o Cxbladderdetect  provides an accurate and cost effective way of
evaluating patients presenting with blood in their urine (haematuria), before
they get to the clinic and

o  Cxbladderdetect is non-invasive and enhances a patient's compliance
with their cancer management regime as defined by the urologist.

For further information please contact

David Darling
Chief Executive Officer
Pacific Edge Limited
P: +64 (3) 4795800

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.
Products in development and in clinical trials are accurate and simple to use
genomic and proteomic tools for the earlier detection, improved
characterisation and better management of gastric, bladder, colorectal
cancers and melanoma. The company has completed and released its first
product for the detection of bladder cancer, Cxbladder, and is actively
marketing the product to physicians and clinicians in New Zealand, Australia
and the USA and soon in Spain.

www.pacificedge.co.nz

ABOUT PACIFIC EDGE DIAGNOSTICS

Pacific Edge takes its exciting cancer detection tests to market through its
wholly owned subsidiaries, Pacific Edge Diagnostics NZ Ltd and Pacific Edge
Diagnostics USA Ltd, and selected commercial partners in Australia and Spain,
Healthscope and Oryzon respectively.

www.pacificedgedx.com

ABOUT Cxbladder

Cxbladder 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 is commercialised in the USA as a Laboratory
Developed Test (LDT).  It provides 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 cancer detection test
has been validated by a multicentre, international clinical study.  Results
published in the Journal of Urology (Sept 2012) show that Cxbladder
out-performed all of the benchmark technologies in the clinical trial and
detected nearly all of the tumours of concern to a urologist; At a
performance of 82% sensitivity and 85% specificity the test sees 100% of T1,
100% of T2, 100% of T3, 100% of Tis and 100% of upper urinary tract cancers
as well as greater than 95% of high grade tumours.

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.

There are a number of 'at risk' occupations that have shown a much higher
incidence of bladder cancer. Fire fighters and fire control officers have
shown in a US study to have a twice the incidence of bladder cancer over non
fire fighters. Smoking is a significant contributing factor (over 50% in
males and 33% in females, and approximately one of every two new incidences
of bladder cancer is linked to smoking). Exposure to certain industrial
chemicals or carcinogens increases risks for some occupations e.g.
hairdressers, painters, printers, fire fighters and metal workers and
chemical engineers. Incidence increases with age so the older you are, the
greater the potential for bladder cancer.

Bladder cancer has a very high recurrence rate of approximately 50%-70% with
up to 30% of these recurring as later stage tumours. This is a higher
recurrence than for skin cancer! However, bladder cancers are highly
treatable, especially if detected in the early stages. If diagnosed early
there is a much higher probability of survival for early stage tumours
relative to later stage tumours. This makes timely and regular surveillance
and monitoring of this cancer a key element of the clinical process and of
the individual's annual healthcare plan.
End CA:00246862 For:PEB    Type:GENERAL    Time:2014-02-11 12:35:52