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MKTUPDTE: PEB: Cxbladder Test Suite Adopted by MidCentral DHB

03 Aug 2017 09:57NZX
Cxbladder Test Suite Adopted by MidCentral DHB

Pacific Edge Signs Agreement Extending Commercial Partnership with MidCentral
District Health Board, to Encompass All Cxbladder Tests for Application
Across the Clinical Pathway

Cancer diagnostics company, Pacific Edge (NZX: PEB), has signed a commercial
agreement with the MidCentral District Health Board (MCDHB) extending its use
to the full suite of Cxbladder cancer tests for use across the clinical
pathway for the detection, management and monitoring of bladder cancer
patients.

In mid-2013, MCDHB was the first New Zealand DHB to commence using Cxbladder
Detect commercially, successfully demonstrating the clinical utility of
Cxbladder to prioritise patients who have non-visible or microscopic
haematuria (blood in the urine and a key indicator of bladder cancer) for
appropriate treatment.

In another first, Cxbladder will now be incorporated into the standard of
care by MCDHB across the bladder cancer pathway from initial diagnosis to
post-treatment surveillance, and reflects the growing recognition of the
benefits and enhanced clinical utility provided by Cxbladder. While the full
suite of tests will be available, Cxbladder Triage and Cxbladder Monitor have
been identified as being of particular interest.

In addition, going forward, patients who have had bladder cancer and are
undergoing routine surveillance within the hospital clinic setting for
recurrence of the disease will now receive Cxbladder Monitor. This test is
targeted to identify those patients who have a low probability of having a
recurrence of the disease and ''ruling them out''. These patients would not be
expected to receive a full urological work-up, providing benefits for both
the healthcare system and patients.

Brent Pownall, Commercial Director of Pacific Edge Diagnostics, said: "We are
delighted with MidCentral DHB''s decision to utilise Cxbladder in their
standard of care. MidCentral have invested a significant amount of time and
resource to validate the clinical utility and performance of Cxbladder.
MidCentral recognised the potential for the product to improve the timeliness
and quality of care for their bladder cancer patients in the urology
department. Today''s agreement with MidCentral supports the company''s goal of
delivering a suite of Cxbladder tests as a ''one stop shop'' to address
multiple needs across the clinical pathway for bladder cancer."

Christophe Chemasle, Clinical Leader of Urology at MCDHB, said: "We have been
using Pacific Edge''s first product, Cxbladder Detect, for a number of years
as part of the commercial evaluation we initiated back in 2013. With the more
recent introduction of the new Cxbladder tests, Triage and Monitor, we now
have access to a complete diagnostic toolkit that covers the whole bladder
cancer pathway. In particular, for patients in the Manawatu/Whanganui region
undergoing surveillance for bladder cancer, using Cxbladder Monitor provides
an obvious benefit for those patients who are identified by the test as not
requiring a cystoscopy."

Under the agreement, MCDHB will provide access for patients throughout the
Manawatu/Whanganui region, with Cxbladder urine sampling systems sent to
selected Medlab laboratory collection centres where the specimen collection
will be carried out, and the samples then sent to Pacific Edge''s certified
Dunedin laboratory for analysis and fast turnaround of test results.

MCDHB is the latest in a growing list of New Zealand District Health Boards
(DHBs) to incorporate Cxbladder into their clinical pathways for urology
services, with Canterbury and Waitemata DHBs also signing agreements in 2016.

Pacific Edge CEO, David Darling, said: "This is another important strategic
achievement for Pacific Edge. New Zealand''s urologists are leading the way in
the adoption of Cxbladder, with public and private healthcare providers and
healthcare insurers recognising the benefits of our accurate, non-invasive
and cost effective Cxbladder tests. We have a long working relationship with
MidCentral and are delighted with this latest agreement."

ENDS

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

OVERVIEW 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 four proprietary, novel, accurate, molecular diagnostic
products in-market providing actionable results, and better detection and
management of urothelial cancer. Cxbladder Triage, Detect and Monitor are
available through the company''s dedicated CLIA-certified laboratories for
customers in New Zealand, Australia, Singapore and the USA. Cxbladder Resolve
launched in New Zealand in December 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 haematuria
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 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.

ABOUT Cxbladder Resolve www.cxbladder.com
Cxbladder Resolve is a proprietary, non-invasive, molecular diagnostic test
that combines genomic biomarkers measured from a small quantity of a
patient''s urine, with patient characteristics for the identification of
patients who are likely to have aggressive or more advanced bladder cancer.
Cxbladder Resolve, when used as part of the primary evaluation of haematuria
and/or in conjunction with other Cxbladder tests (Triage, Detect), is
designed to assist clinicians by accurately identifying patients with a high
probability of having high grade or late stage bladder cancer, for whom
alternative or expedited treatment options may be warranted, or who can be
prioritised for further investigation in high throughput settings.

Refer to www.cxbladder.com for more information.
End CA:00304969 For:PEB    Type:MKTUPDTE   Time:2017-08-03 09:57:40
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