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Another NZ Public Healthcare Provider Signs Up to Cxbladder

Operational Update14 August 2018PEBHealthcare

Company Announcement
14 August 2018

1


ANOTHER NEW ZEALAND PUBLIC HEALTHCARE PROVIDER SIGNS UP TO CXBLADDER

Counties Manukau Health to Adopt Cxbladder Tests for Application Across the Clinical Pathway


Cancer diagnostics company Pacific Edge (NZX: PEB) has received notification from Counties Manukau District

Health Board (CMDHB) regarding adoption of the suite of Cxbladder cancer diagnostic tests for use across

the clinical pathway.


From September, Cxbladder will be incorporated into the standard of care by CMDHB across the bladder

cancer pathway from investigation of haematuria (blood in the urine) and initial diagnosis, through to post-

treatment surveillance.


Counties Manukau is New Zealand’s second largest DHB and serves an estimated population of over half a

million people, representing approximately 12% of New Zealand’s population.


Brent Pownall, VP Commercial and Franchise at Pacific Edge, said: “This is a big step forward for Cxbladder in

New Zealand and for the urology patients in the Auckland region. We are aware of lengthy waiting times for

patients referred to CMDHB for investigation of haematuria and based on our experience with Cxbladder in

other DHBs, and the growing body of peer-reviewed clinical publications, we are confident that Cxbladder

will have a significant impact on the timeliness and quality of care for these urology patients.”


The agreement with Counties Manukau follows successful commercial implementation by a number of New

Zealand DHBs. Canterbury, Waitemata, MidCentral and BOP/Lakes DHBs have incorporated Cxbladder into

their clinical pathways for urology services and are now routinely using the tests. This reflects the growing

recognition of Cxbladder by large healthcare organisations, both in New Zealand and internationally.


Pacific Edge CEO David Darling, said: “The addition of Counties Manuakau DHB to the list of New Zealand’s

public healthcare providers who have adopted Cxbladder commercially, provides further evidence of the

broad clinical buy-in from New Zealand’s urologists who are now routinely using Cxbladder. The New Zealand

public healthcare system is leading the way with the adoption and integration of Cxbladder into their

standard of care where more than 50% of the population now have ready access to Cxbladder through their

local DHB.”


ENDS


For more information contact:

David Darling

Chief Executive Officer

Pacific Edge Ltd

P: +64 (3) 479 5800



Company Announcement
14 August 2018

2

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.

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