Ann: GENERAL: PEB: PE seeks additional laboratory accreditation

• Release Date: 21/04/15 10:05
• Summary: GENERAL: PEB: PE seeks additional laboratory accreditation
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					PEB
21/04/2015 10:05
GENERAL
NOT PRICE SENSITIVE
REL: 1005 HRS Pacific Edge Limited

GENERAL: PEB: PE seeks additional laboratory accreditation

21 April 2015

Pacific Edge seeks additional laboratory accreditation as it pursues
international opportunities

NZX-listed Pacific Edge today confirmed that it was seeking accreditation
from International Accreditation New Zealand (IANZ) for its Dunedin-based
diagnostics operation as it looks to pursue further international
commercialisation opportunities for Cxbladder.

The company's Dunedin based clinical laboratory operation has been
successfully assessed by IANZ. Formal approval for Pacific Edge Diagnostics
NZ Ltd laboratory is expected to take up to six weeks. The assessment is 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".

Pacific Edge Diagnostics NZ Quality Manager Lisa Cambridge said: "Formal
accreditation of our technical competency and quality for the New Zealand
based laboratory will provide 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. Once obtained we will be
able to meet the needs of new commercialisation opportunities that the
company may wish to pursue."

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 is tracking to the company's expectations
following an active direct sales and marketing program to clinicians and
healthcare organisations. Pacific Edge Diagnostics USA has twelve 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 laboratory 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 bladder
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:00263349 For:PEB    Type:GENERAL    Time:2015-04-21 10:05:30