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Announcement

GENERAL: PEB: Positive Results in Kaiser Permanente User Programme

14 Nov 2016 10:12NZX
14 November 2016

POSITIVE RESULTS IN KAISER PERMANENTE USER PROGRAMME

Cancer diagnostics company Pacific Edge (NZX: PEB) has advised that it has
successfully completed its analysis of the data from the large scale Kaiser
Permanente (Kaiser) User Programme with positive and compelling findings.

The performance of Pacific Edge''s Cxbladder Triage test was evaluated in a
large, blinded study (User Programme) on consenting Kaiser patients, with
findings equivalent to the previously published performance for Cxbladder
Triage. Kaiser is currently completing its own analysis of the data, with the
joint analysis to be submitted for scientific and clinical publication.

Cxbladder Triage is designed to rule out patients who have a low risk of
having urothelial cancer (bladder cancer). A previously published study on
Cxbladder Triage''s performance, in the BioMed Central (BMC) Urology Journal
in April 2015, showed a sensitivity of 95.1% and a Negative Predictive Value
of 98.5%, meaning that Cxbladder Triage accurately identified those patients
that had a low probability of having bladder cancer and therefore did not
require a full workup for bladder cancer.

CEO and Managing Director of Pacific Edge, David Darling, said: "The positive
confirmation and validation of the performance of Cxbladder Triage in the
Kaiser clinical setting, where the diagnosis was blinded to us until the end
of the study, is a direct reflection of the quality of the Cxbladder Triage
test.

"Our analysis further validates Cxbladder''s clinical utility in haematuria
and bladder cancer management and supports our goal to create diagnostic
tests that are highly accurate, non-invasive, cost effective and simple to
use. Cxbladder Triage can potentially save many patients from undergoing an
expensive and invasive investigation for bladder cancer."

The purpose of the User Programme was to allow Kaiser to assess the use of
Cxbladder Triage in Kaiser''s own clinical settings, to effectively and
accurately rule out those patients who present with haematuria who have a
low probability of having bladder cancer and therefore may not need a full
clinical workup.

David Darling commented: "Kaiser Permanente is one of America''s largest
not-for-profit health care providers, with a strong vision for improving
patient outcomes. We are looking forward to working with Kaiser to
scientifically publish the detailed results and negotiate a commercial
relationship".

ENDS

For more information contact:

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

OVERVIEW www.pacificedge.co.nz www.pacificedgedx.com

Pacific Edge Limited (NZX: PEB) is a New Zealand publicly listed, cancer
diagnostic company specialising in the discovery and commercialisation of
diagnostic and prognostic tests for better detection and management of
cancer. The company is developing and commercialising its range of Cxbladder
bladder cancer tests globally through its wholly owned central laboratories
in New Zealand and the USA. The company''s products have been tested and
validated in international multi-centre clinical studies.

Pacific Edge has three proprietary, novel, accurate, molecular diagnostic
products in-market providing actionable results, and better detection and
management of urothelial cancer. Cxbladder Detect and Cxbladder Triage are
available through the company''s dedicated CLIA certified laboratories for
customers in New Zealand, Australia and the USA. Cxbladder Monitor launched
in New Zealand in December 2015 and is anticipated being available in the US
in 2016.

ABOUT Cxbladder Triage www.cxbladder.com

Cxbladder Triage combines the power of the genomic biomarkers with additional
phenotypic and clinical risk factors to accurately identify patients with
haematuria who have a low probability of bladder cancer and may not require a
more extensive urological evaluation. Cxbladder Triage is a tool for use by
clinicians and physicians in primary evaluation of patients with hematuria
and is intended to reduce the need for an expensive and invasive work-up in
patients who have a low probability of having urothelial carcinoma.

ABOUT Cxbladder Detect www.cxbladder.com

Cxbladder Detect enables the non-invasive detection of bladder and other
urinary tract cancers from a small volume of a patients'' urine. Cxbladder
Detect was launched in 2013 in the USA and is commercially available in New
Zealand, Australia and the USA as a Laboratory Developed Test (LDT) from the
company''s CLIA certified laboratories. Cxbladder Detect provides physicians
and clinicians with a quick, cost effective and accurate measure of the
presence of the cancer as an effective adjunct to cystoscopy.

ABOUT Cxbladder Monitor www.cxbladder.com

Cxbladder Monitor, the third test in the Cxbladder portfolio for urologists,
is a proprietary, non-invasive, molecular diagnostic test that combines
genomic biomarkers measured from a small quantity of a patient''s urine, with
patient specific clinical factors to better monitor bladder cancer patients
for recurrence. Bladder cancer has a recurrence rate of 50-80% and requires
life-long surveillance. Cxbladder Monitor accurately identifies patients with
a prior history of urothelial cancer (UC) whose Cxbladder Monitor score shows
that they have a low probability of recurrent urothelial carcinoma. Cxbladder
Monitor is designed to be used as the preferred adjunct test to cystoscopy in
the management of patients for ongoing evaluation of recurrent bladder
cancer.

Refer to www.cxbladder.com for more information.
End CA:00292574 For:PEB    Type:GENERAL    Time:2016-11-14 10:12:00
Views: 269
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