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Cxbladder included in the NCCN Bladder Cancer Guidelines

Operational Update15 July 2019PEBHealthcare

Company Announcement
15 July 2019



CXBLADDER INCLUDED IN THE LATEST NCCN BLADDER CANCER GUIDELINES IN THE USA


Cancer diagnostics company, Pacific Edge (NZX: PEB), advises that Cxbladder has been included in the latest version

of the National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer in the USA.


This is a significant achievement with the NCCN Guidelines widely recognised and used as the standard for clinical

policy and practice in oncology by clinicians and payors in the USA.


The new guidelines update, which was issued on 10 July 2019, state that the evaluation of urinary urothelial tumor

markers (Cxbladder by direct reference) may be considered during surveillance of high-risk non-muscle-invasive

bladder cancer. The NCCN Bladder Cancer Panel considers this a category 2B recommendation, which means there

is NCCN consensus that the use of Cxbladder as a clinical intervention is appropriate. This follows on from

Cxbladder’s inclusion in clinical guidelines by several New Zealand public healthcare providers in the last year.

To be considered for review and inclusion in the NCCN guidelines requires an extensive portfolio of clinical evidence,

a track record of clinical use, and broad adoption by physicians.


This is an important milestone for Pacific Edge’s commercial journey in the USA, says CEO, David Darling, and comes

on the back of 10 years of successful clinical evidence and commercial development.


“Over the preceding years many of our customers in the USA have been hampered in their commercial use of

Cxbladder while the Cxbladder technology has not been specifically included in the guideline recommendations.

Inclusion in the NCCN Bladder Cancer guidelines is a major commercial milestone for the Company in the USA and

will be of significant value as we progress our commercial discussions with our many urologist customers including

the large healthcare organisations we are targeting.”


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. Its Cxbladder suite of

non-invasive, simple to use and accurate diagnostic tests provide actionable results, and better detection and management of

urothelial 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.


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

Company Announcement
15 July 2019

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 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 allows urologists to monitor bladder cancer patients for recurrence of the disease. 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 identifies those 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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