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Full Suite of Cxbladder Tests adopted by Capital &Coast DHB

Operational Update8 November 2018PEBHealthcare

Company Announcement
8 November 2018


FULL SUITE OF CXBLADDER TESTS ADOPTED BY NEW ZEALAND PUBLIC HEALTHCARE

PROVIDER CAPITAL & COAST DHB


Pacific Edge signs agreement with Capital & Coast District Health Board, providing access to full suite of

Cxbladder products


Cancer diagnostics company, Pacific Edge (NZX: PEB), has entered into an agreement with one of New

Zealand’s largest public healthcare providers, Capital & Coast District Health Board (CCDHB), to provide its

suite of Cxbladder cancer diagnostic tests for the detection, management and monitoring of bladder cancer

patients.


Capital & Coast is the latest in a rapidly expanding list of New Zealand public healthcare providers to

incorporate Cxbladder into their clinical pathways for urology services. Capital & Coast joins the recent

signing of public healthcare providers Counties Manukau and Tairawhiti DHBs who have signed agreements

within the last quarter. These new commercial users join the existing public healthcare providers in

Canterbury, Bay Of Plenty/Lakes, MidCentral and Waitemata in their use of Cxbladder bringing the total

coverage of New Zealand’s population under contract to more than 60%.


The full suite of easy-to-use, accurate and non-invasive Cxbladder urine tests will be used by CCDHB

healthcare professionals at key decision points in the bladder cancer clinical pathway, from evaluation of

blood in the urine (haematuria) a key indicator of bladder cancer, through to management and monitoring

for recurrence of the disease.


Under the agreement, the Cxbladder urine sampling systems will be sent out to selected Wellington

laboratory collection centres throughout the greater Wellington region, 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.


Brent Pownall, VP Commercial and Franchise at Pacific Edge, said: “Capital and Coast [DHB] have been using

Cxbladder on a limited scale now for a few years, and are very familiar with the different applications for the

tests. Armed with the Cxbladder test results, we are confident they can safely and effectively change the way

they manage haematuria referrals and bladder cancer surveillance for patients in the greater Wellington

region, with the clear benefit for patients identified as not requiring an invasive cystoscopy procedure.”


“This is another significant commercial milestone in our goal to make Cxbladder the urologists’ preferred

diagnostic tool across the clinical pathway for haematuria and bladder cancer follow-up for New Zealand

physicians and patients alike. Today’s agreement with CCDHB provides coverage for patients for all four

Cxbladder products.”


ENDS


For more information contact:

David Darling

Chief Executive Officer

Pacific Edge Ltd

P: +64 (3) 479 5800

Company Announcement
8 November 2018


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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