PEB
10/09/2013 11:14
GENERAL
REL: 1114 HRS Pacific Edge Limited
GENERAL: PEB: Cxbladder excels in New Zealand
10 September 2013
Cxbladder excels in New Zealand
New Zealand clinicians and healthcare providers are excited about Pacific
Edge Limited's cancer detection system Cxbladder for its ability to detect
bladder cancer with a high degree of accuracy.
Two User Programmes in New Zealand - a combined study of 178 patients with
macro-haematuria (blood in urine) has found that Cxbladderdetect outperforms
cytology and saw 90% of all tumours. The full results are being prepared for
publication.
The User Programme studies were conducted at two centres by Tony Beaven and
Sue Osborne in conjunction with the Waitemata District Health Board (DHB);
and Nick Buchan, Peter Davidson, Liz Mitchell and Barbara Gordon of
Canterbury Urology Research Trust in conjunction with Canterbury DHB.
The study confirms the results of a larger, multi-centre Australasian study
published last September in the peer reviewed Journal of Urology in the
United States where Cxbladder outperformed the other commercially available
tests benchmarked in the study. In that large study at a specificity of 85%
Cxbladderdetect saw 100 % of T1, 100% of T2, 100% of T3, 100% of Tis and 100%
of upper urinary tract cancers. Cxbladderdetect also saw 97% of high grade
tumours.
Pacific Edge's Commercial Manager, Brent Pownall, says the New Zealand user
study demonstrates that Cxbladderdetect is a highly accurate and efficient
detection test for urothelial carcinomas in the New Zealand healthcare
context. "We look forward to having this product more widely used in New
Zealand's healthcare programmes, thus benefiting DHBs, clinicians and
patients alike."
"Cxbladderdetect gives clinicians and patients a high degree of assurance
that the results are accurate which cytology cannot achieve to the same
degree. In combination with cystoscopy, Cxbladderdetect will provide
significant clinical upside, benefiting both patients and clinicians."
"Patients presenting with haematuria who are given the choice of providing a
urine sample for Cxbladderdetect, or undergo an extensive work-up and
experience the discomfort of cystocopy, are likely to choose Cxbladderdetect
every time."
For our DHBs which are focused on providing the very best cost effective
healthcare for New Zealanders, Cxbladderdetect provides a number of
significant advantages:
oThe Urine Sampling System can be sent directly to the patient at home,
thereby minimising the need to queue to see a specialist and the
inconvenience of another trip to the doctor or pathology lab collection
centre
oCxbladderdetect provides a cost effective way of evaluating patients
presenting with haematuria before they get to the clinic and
oCxbladderdetect does it in a non-invasive way.
Mid Central DHB based in Palmerston North is underway with their programme
targeting Cxbladderdetect for yet another clinical value proposition that is
expected to see a proportion of patients with haematuria, not having to come
into the clinic for a full work-up.
Paul O'Sullivan, Pacific Edge's Clinical Science Manager, outlined that the
User Programme studies for Waitemata and Canterbury are based on 178 patients
presenting with haematuria undergoing investigations for possible urothelial
carcinomas. All were tested using Cxbladderdetect as part of their clinical
work-up. Results of the Cxbladderdetect test were compared with urine
cytology and cystoscopic findings to determine the clinical utility of the
Cxbladderdetect test.
"Cxbladderdetect proved its superiority over cytology by a wide margin in
detecting 90% of the cases of urothelial carcinomas amongst the 178 patients.
On one site Cxbladderdetect correctly detected 100% of the patients with
urolthelial carcinoma. It also demonstrated its ability to correctly screen
out patients who did not have urothelial carcinomas, which the study noted
was particularly beneficial in patients presenting with haematuria."
The study results will be published by way of a presentation at the
Urological Society of Australia and New Zealand (USANZ) Annual Scientific
Meeting in March 2014.
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 recently completed and released its
first product for the detection of bladder cancer, Cxbladder, and is actively
marketing the product to urologists in New Zealand, Australia, and USA and
soon to 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 Limited and Pacific
Edge Diagnostics USA Limited, and selected commercial partners in Australia
and Spain, Healthscope Pathology and Oryzon respectively.
www.pacificedgedx.com
ABOUT Cxbladder
Cxbladder is a non-invasive, accurate test that enables the early detection
of bladder cancer from a small volume of urine. It provides general
practitioners and urologists 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 recently published, Journal of Urology in September 2012,
multi-centre international clinical study recruited 485 patients from
Australia and New Zealand. Results show that Cxbladder out-performed all
other benchmark technologies in the
clinical trial and detected nearly all of the tumours of concern to a
urologist; At 85% specificity, the test sees 100% of T1, T2, T3, Tis and
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:00240937 For:PEB Type:GENERAL Time:2013-09-10 11:14:10
