PEB
10/02/2014 15:11
GENERAL
REL: 1511 HRS Pacific Edge Limited
GENERAL: PEB: Health Innovation Hub signs commercial agreement
10 February 2014
Health Innovation Hub signs commercial agreement for entry of Cxbladder to
DHB's
The Health Innovation Hub (HIH) has signed a commercial agreement to engage
DHBs in the adoption of Pacific Edge's non-invasive bladder cancer detection
system Cxbladder, making it accessable for nearly one out of every two New
Zealanders.
As a result of the agreement Cxbladder will be considered for use to evaluate
patients presenting with haematuria, a symptom of possible bladder cancer, in
clinics operated by the four largest District Health Boards (DHBs), Auckland,
Waitemata, Counties Manukau and Canterbury.
The HIH is a recently formed government enterprise with a mandate to enable
technology commercialisation into and out of the country's four largest DHBs.
Pacific Edge Chief Executive Officer David Darling says the agreement with
HIH is especially poignant.
"Cxbladder has been clinically tested in some of these DHBs, in conjunction
with their respective urologists who work in both the public arena and
private practice. The decision of HIH to now assist the adoption of Cxbladder
is a strong endorsement of its ability to deliver sound clinical outcomes for
patients and significant savings in time and expense for DHBs."
Cxbladder has recently also completed a blinded User Program in both
Waitemata and Canterbury DHB's with outstanding results validating Cxbladder
in these clinical settings.
"It was particularly pleasing to see such great results from these blinded
studies, confirming the outcome of the large clinical study published in the
Journal of Urology in the United States in September 2012," says David
Darling.
The Health Innovation Hub Chief Executive Officer Frances Guyett says
identifying and forming strategic relationships with key external partners to
accelerate commercialisation by enabling access to DHBs is one of the HIH's
key objectives.
"Pacific Edge is an innovative New Zealand company with demonstrated export
potential. The Health Innovation Hub is passionate that New Zealanders should
benefit from access to the same innovative health products that international
markets do. Cxbladder is an exciting innovation with the potential to bring
benefits to millions of people who show the symptoms of or need monitoring
for bladder cancer.."
The agreement with HIH builds on a momentous 12 months for Pacific Edge.
During 2013 the Dunedin-based cancer diagnostic company attained regulatory
approval from CLIA, for both their Dunedin commercial laboratory and its
purpose built Cxbladder testing laboratory in Hershey, Pennsylvania. In the
United States, the world's largest healthcare market, Cxbladder has been
commercially launched, achieved sales and signed agreements with several
large national provider networks to give more than 50 million Americans
access to the bladder cancer diagnostic system. Other milestones included an
agreement with Mid Central DHB based in Palmerston North to use Cxbladder to
evaluate patients presenting with haematuria.
Cxbladder detects nearly 100 per cent of urothelial carcinomas, in preference
to cytology for the detection and monitoring of patients who may have bladder
cancer.
Pacific Edge Chief Executive Officer David Darling says the Government must
be congratulated for creating the Health Innovation Hub in 2011 as a catalyst
for the commercialisation of new innovative medical technologies coming from,
and entering the health technology sector. There are a number of significant
changes taking place in the procurement and adoption of step-change
technology in the healthcare system New Zealand and part of those changes is
a more expedient process for adoption of technology that will lower cost and
or improve patient outcomes.
"New Zealanders will be the real winners of this initiative. Half the
population are now able to more expediently access Cxbladder technology
providing a highly accurate and efficient alternative to the other diagnostic
techniques now commonly used. The option of patients being able to give a
urine sample at home and for clinicians to receive the results a few days
later has the potential to offer DHBs significant cost benefits by reducing
the number of patients requiring a full clinical work-up."
In addition to Pacific Edge's own subsidiaries offering Cxbladder in the
United States and NZ, Cxbladder is being marketed in Australia by
Healthscope, a leading healthcare provider, and is due to be launched in
Spain, which has one of the highest incidences of bladder cancer, this year.
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
Editor's note: The combined population of Auckland, Waitemata, Counties
Manukau, Canterbury and Mid Central DHBs is 2.208 million - source DHB
websites
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.
ABOUT New Zealand Health Innovation Hub
The New Zealand Health Innovation Hub's purpose is to build a healthier world
through smart innovation by becoming a world leader in accelerating
health-related innovations from ideas to market through the establishment and
on-going development of strategic partnerships, accelerateing product and
service realisation, and leveraging the capilities and resoureces within the
public healthcare sector and particpating DHB's to optimise healthcare
benefits.
innovation.health.nz
End CA:00246809 For:PEB Type:GENERAL Time:2014-02-10 15:11:10
