Cxb Monitor significantly outperforms FDA approved tests

Company Announcement
6 March 2017

CXBLADDER MONITOR SIGNIFICANTLY OUTPERFORMS ALL FDA APPROVED URINE TESTS
FOR BLADDER CANCER
Cxbladder Monitor clinical paper accepted for publication in Journal of Urologic Oncology

The prestigious international journal Urological Oncology, has accepted for publication a scientific and clinical paper
validating the superior performance of Pacific Edge’s Cxbladder Monitor test for the surveillance of patients who are
being managed following treatment for bladder cancer. This follows the recently announced acceptance for publication
of the Cxbladder Monitor validation study in the American Journal of Urology.

Titled “Clinical Comparison of Non-invasive Urine Tests for Ruling Out Recurrent Urothelial Carcinoma of the
Bladder”, the paper compared the performance of the Cxbladder Monitor test to other commonly available urine
markers and cytology for surveillance of patients with urothelial carcinoma (bladder cancer).

Specifically, the paper, based on a Clinical Research Organisation (CRO) managed study with data from over 1100 USA
patient samples, found that the Cxbladder Monitor test significantly outperforms current Food and Drug
Administration (FDA) approved urine-based monitoring tests, including cytology and UroVysion® FISH, in a large
representative population undergoing surveillance for recurrent urothelial carcinoma
1
. This supports using Cxbladder
Monitor as a confirmatory negative adjunct to cystoscopy or to justify postponing cystoscopic investigations in select
patients. The paper concludes that this performance signals a step change in clinical utility for urologists managing
patients in a surveillance regime for recurrence of the disease.

The paper also concluded that Cxbladder Monitor provides clinicians with a greater degree of certainty when
monitoring for recurrent bladder cancer, or when used as a direct rule-out test for patients identified as being at low
risk for recurrent disease, thereby avoiding cystoscopies in those patients that have a negative Cxbladder Monitor
result.

The paper noted that currently the major limitations in the other existing urine tests used for the monitoring of
patients to date has been inadequate sensitivity, particularly for early stage and low grade tumours that account for a
significant proportion of recurrences. Cxbladder Monitor combines high sensitivity and high Negative Predictive Value
(NPV), both of which are essential for an effective rule-out test, outperforming all comparator tests irrespective of the
patient’s age and gender, recurrent tumour size, stage and grade, or duration post-treatment with adjuvant BCG.

Chief Executive Officer of Pacific Edge, David Darling, commented: “Cxbladder Monitor has been highlighted in this
journal for its outstanding performance in the monitoring of bladder cancer. Overall, it offers an ‘increase in clinical
utility warranting consideration for inclusion in the guidelines’. As stated in the paper Cxbladder Monitor ‘significantly
out performs current FDA approved urine tests used in the management of bladder cancer’.





1
Study Results: The sensitivity of Cxbladder Monitor (0.91) significantly outperformed cytology (0.20), NMP22® enzyme-
linked immunosorbent assay (0.26) and NMP22® BladderChek® (0.11). The negative predictive value of Cxbladder Monitor
was also superior at 0.96 compared with cytology (0.87), NMP22® enzyme-linked immunosorbent assay (0.87), NMP22®
BladderChek® (0.86). UroVysion® FISH also had inferior sensitivity (0.36) and negative predictive value (0.92) compared to
Cxbladder Monitor. All false negative results (n=14) observed using Cxbladder Monitor were also negative for cytology,
NMP22® enzyme-linked immunosorbent assay and NMP22® BladderChek®, and UroVysion® FISH.

Company Announcement
6 March 2017

“Cxbladder Monitor provides an opportunity to enhance the standard of care for bladder cancer patients, making
surveillance of patients with this disease and the monitoring for the recurrence of the disease, more effective and
importantly for the patient, less invasive. The paper supports our strategy to provide a ‘one stop shop’ of high
performance bladder cancer products designed to meet targeted clinical needs.”

“Cxbladder Monitor has recently been adopted in New Zealand by the Waitemata District Health Board and added to
their standard of care for evaluation of low risk patients who are presenting to the clinic for evaluation for the
recurrence of the disease. For these low risk patients Cxbladder has replaced cystoscopy.”

The peer reviewed paper will be published in the online edition of Urological Oncology, which provides practical,
timely, and relevant clinical and basic science information to physicians and researchers practicing urology worldwide.
The print copy publication will be available on the next edition of the Journal.

Cxbladder Monitor, sensitivity of 0.93 and Negative Predictive Value (NPV) 0.97, was launched in New Zealand in
December 2015, and late 2016 in the USA following acceptance for publication of the clinical validation study. It is the
third of Pacific Edge’s cancer diagnostic tests, as the company continues to build its ‘one stop shop’ of accurate and
non-invasive cancer diagnostic tests. Cxbladder Triage helps to rule out cancer in patients who have a low probability of
having urothelial cancer; Cxbladder Detect is used specifically to detect bladder cancer; and Cxbladder Monitor
provides urologists who are evaluating patients for the recurrence of the disease, with greater certainty of their clinical
evaluations, and patients with a non-invasive way to monitor their disease.

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 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

Company Announcement
6 March 2017
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.