Ann: GENERAL: PEB: Pacific Edge's US Laborato

• Release Date: 18/03/13 13:08
• Summary: GENERAL: PEB: Pacific Edge's US Laboratory Receives CLIA Registration
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18/03/2013 11:08
GENERAL

REL: 1108 HRS Pacific Edge Limited

GENERAL: PEB: Pacific Edge's US Laboratory Receives CLIA Registration

Private and confidential

18 March 2013

Pacific Edge's US laboratory receives CLIA registration for Cxbladder

Cancer diagnostic specialist Pacific Edge has achieved a major milestone with
notification that its commercial laboratory in Hershey, Pennsylvania, has
gained registration under the CLIA  regulatory process clearing the way for
the launch of Cxbladder in the United States.

Specifically,  CLIA1 registration now enables Pacific Edge's US laboratory to
operate and provide commercial services to clinicians and process urine
samples from patients in the United States for its Laboratory Developed test
(LDT) Cxbladder. Chief Executive Officer David Darling says CLIA registration
is a very significant commercial milestone for the Company and has been
achieved within the expected time-frame and budget.

"This progress is great news for all stakeholders and tremendous recognition
for the Pacific Edge US and NZ teams who have made this happen in such a
professional and expedient manner. The US is the world's largest healthcare
market and the most important market for Cxbladder. The Company now has a
commercial capability to reach its prime customer base."

 Jackie Walker, the Chief Executive Officer of Pacific Edge's US subsidiary
Pacific Edge Diagnostics USA (PEDUSA) says CLIA registration signals the
transition to a full commercialisation phase enabling us to roll-out our
sales and marketing program over the next few months for Cxbladder our
non-invasive diagnostic test for bladder cancer.

"Cxbladder can now be offered by US clinicians to patients with reimbursement
by medical insurers and patients' 'out of pocket payment'. Bladder cancer has
the highest total medical costs of any cancer, at approximately $US200,000
per patient over the full course of the disease. The Cxbladder test offers
significant cost benefits to insurers as well as increasing the ease and
comfort for patients."

Pacific Edge already has the nucleus of its sales and marketing team in place
in the United States and has been working progressively with leading
urologists on the application of Cxbladder to their clinical practice.
Further appointments to the sales and marketing team will be made over the
next few months. CLIA registration of the PEDUSA facility follows the recent
publication in the prestigious Journal of Urology of the peer reviewed
scientific paper on Cxbladder's clinical study performence.

Urine samples collected by the urologist for Pacific Edge's proprietary test
will now be shipped to the state-of-the-art laboratory in Hershey,
Pennsylvania, for processing and analysis to detect the molecular indicators
of tumours in the bladder.

"Cxbladder is already attracting keen interest from clinicians and bladder
cancer patients who have become aware of the test and its performance,
providing them an opportunity for a greater resolution of their disease. The
simple urine sample collection process is also seen by many patients as a
means of escaping some of the invasive and discomforting testing regime they
currently endure. These patients will welcome the introduction of Cxbladder
in the US and are expected to encourage their clinicians to adopt it," Jackie
Walker says. Patients diagnosed with bladder cancer need to undergo regular
testing for up to five years following initial diagnosis and treatment, much
of which is invasive and expensive.

Even so, Pacific Edge expects a gradual take up of Cxbladder in the US and in
Australia, New Zealand,  where it is also now available. Cxbladder is
expected to be commercially available in Spain soon as well.

"Cxbladder's sales in the US will have minimal impact on Pacific Edge
revenues in this current financial year as we bring the sales and marketing
resources to bear and invest strongly in getting the message and product out
to the clinicians. Revenue from the US is expected to develop over 2013 as
our sales teams build relationships with clinicians. We will be launching
with a new web site and a US specific marketing strategy. This is an
exciting time and a great growth opportunity for a New Zealand company and is
anticipated to be the gateway to a strong revenue performance for Pacific
Edge. " David Darling says.

"The United States is the largest and most important healthcare market in the
world. Its complexity is challenging but Pacific Edge is confident that in
PEDUSA it has the people at board, executive and technical levels with the
depth of experience in launching biomedical products in the United States.
This will ensure that clinicians, patients and health funding agencies are
fully aware of Cxbladder and its abilities to detect bladder cancer. The
capability to build this business opportunity in the US off the back of the
New Zealand business has been a significant factor in enabling this market
channel to be delivered quickly and very cost-effectively"

The launch of Cxbladder in the United States follows licensing agreements
with Oryzon in Spain for Spain (Spain having the highest incidence of bladder
cancer in the world), and  Healthscope in Australia. Urologists and general
practitioners in New Zealand and Australia are also showing keen interest in
using Cxbladder, with a number of them undergoing an in-practice evaluation
of Cxbladder to determine how  Cxbladder can best work in their practices.
Cxbladder is expected to be widely used as an adjunct to cystoscopy for
patients presenting with haematuria and returning to the clinic for on-going
monitoring.

For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800

Footnote:
1: The Clinical Laboratory Improvement Amendment, CLIA, sets standards and
issues certificates for clinical laboratory testing in the United States. It
is administered by the US Centre for Medicare and Medicaid Services, CMS.

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 soon to be
Spain and the US.

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 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 of
the 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 twonew 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:00234251 For:PEB    Type:GENERAL    Time:2013-03-18 11:08:47