Ann: GENERAL: PEB: Pacific Edge is successful in obtaining ISO accreditation

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• Summary: GENERAL: PEB: Pacific Edge is successful in obtaining ISO accreditation
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07/05/2015 14:00
GENERAL
NOT PRICE SENSITIVE
REL: 1400 HRS Pacific Edge Limited

GENERAL: PEB: Pacific Edge is successful in obtaining ISO accreditation

8 May 2015

Pacific Edge is successful in obtaining ISO accreditation

NZX-Listed Pacific Edge Limited today advises its Dunedin-based laboratory
has been awarded ISO accreditation status, further opening up international
selling opportunities. The assessment was done by the International
Accreditation New Zealand (IANZ) for the International Standard; ISO15189 :
2012 for Medical Laboratories.

Pacific Edge Chief Executive David Darling said: "Gaining the IANZ
accreditation is a very important step for us particularly for the commercial
servicing of markets, such as those in South East Asia, using our New Zealand
based laboratory. It is yet another milestone for us as we seek commercial
opportunities".

Pacific Edge Diagnostics NZ Quality Manager Lisa Cambridge said: "The
accreditation was for the technical competency and quality of our New Zealand
based laboratory. This provides us with national and international quality
recognition and will compliment the USA based CLIA accreditation that has
already been gained by our clinical laboratory here in Dunedin."

The IANZ process assesses and accredits applicants against standards in a
number of fields of technology, including those developed by the
International Organisation for Standardisation, a worldwide federation made
up of 163 member countries who develop international standards.

Accreditation is a formal recognition of technical competency through
assessment, including an annual on-site assessment of an organisation's
quality management system and competency in technical areas such as staff,
methods and equipment, testing and quality control.

David Darling noted that while Pacific Edge continued to look at ways of
securing its ground-breaking cancer technology in global markets, its main
focus remained on building sales momentum in the US, the world's largest
healthcare market. "We are now in our second year of commercial operations
there. Laboratory throughput continues to track to the company's
expectations following an active direct sales and marketing program to
clinicians and healthcare organisations. Pacific Edge Diagnostics USA has 12
dedicated sales executives operating in key geographic regions."

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:00264061 For:PEB    Type:GENERAL    Time:2015-05-07 14:00:10