Outperformance confirmed from combined use of Cxbladder

8 July 2021

COMBINED USE OF CXBLADDER PRODUCTS SHOWS SIGNIFICANT OUTPERFORMANCE

• A pivotal, peer-reviewed paper, accepted for publication in the Journal of Urology, demonstrates the
significant clinical and patient benefits from the use of a combination of Cxbladder products to correctly
identify haematuria patients, who have urothelial cancer (UC)
1
and also, further segregate those patients
with high-impact tumours (HIT) requiring priority investigation.

• Of significant importance, the study concluded that the sequential use of the Cxbladder products
achieved 4.8 times greater efficiency in accurately assigning patients to the physician’s prioritisation of
investigation than the latest American Urology Association (AUA) 2020 guidelines.

Cancer diagnostics company, Pacific Edge Limited, is pleased to advise that a new scientific and clinical paper
validating the diagnostic performance of its fourth Cxbladder test, Cxbladder Resolve (CxbR), has been accepted for
publication in the Journal of Urology. The Journal of Urology is the official Journal of the AUA and the most widely
read and highly cited journal in the field of Urology.

Cxbladder Resolve was designed for use by a physician following a patient’s initial evaluation using both Cxbladder
Triage (CxbT) and Detect (CxbD). Those patients that test positive to CxbT and then also test positive to CxbD, will
receive the Cxbladder Resolve (CxbR) test. CxbR accurately identifies those patients with a high-impact tumour
(HIT), who require high priority intervention by their urologist. High-impact tumours are those that have the highest
probability of invasion and progression and where early detection is critical for a successful outcome.

The paper titled ‘Cxbladder for prioritising high-risk urothelial cancer patients’ evaluates the use of Cxbladder
Resolve, alone and in combination with other Cxbladder tests, to identify and prioritise patients at high risk for
urothelial carcinoma/cancer’ (UC)
2
. Cxbladder Resolve was developed on 863 haematuria
3
patients recruited in the
US, New Zealand and Australia; and then tested, both separately and in combination with other Cxbladder tests,
on a further 548 Kaiser Permanente patients, with outstanding results.

Of note, Cxbladder Resolve correctly identified all patients with high-impact tumours, allowing those patients to
be prioritised for further investigation.

The paper concluded that Cxbladder Resolve has high sensitivity (92.4%) and specificity (93.8%) and correctly
identified all high-impact tumours. In addition, sequential use of Cxbladder tests accurately segregated patients
with a low vs high probability of high-impact tumours, enabling the prioritisation of physician resources for these
patients.

With the sequential use of Cxbladder tests for each patient (Triage, followed by Detect, followed by Resolve):
• 87.6% of patients were correctly ruled out from requiring further workup (negative predictive value 99.4%)
• 100% of high-impact tumours were accurately identified for prioritised investigation in both study cohorts


1
Urothelial carcinoma/cancer includes bladder cancer and cancers of the upper urinary tract
2
Urothelial carcinoma/cancer includes bladder cancer and cancers of the upper urinary tract
3
Haematuria is blood in the urine and a key indicator of bladder cancer.

8 July 2021
CEO of Pacific Edge, David Darling, said: “Our long-standing strategy has been to develop a suite of Cxbladder
products that can be used alone or in combination to address unmet needs across the entire clinical pathway for
urothelial cancer. This is a pivotal paper for urologists, outlining the significant increase in clinical resolution that
can be achieved from using the multiple Cxbladder products in this fashion. This is the first time that the clinical
benefits of this novel approach have been validated.

“The paper confirmed that the combined use of three of our Cxbladder products for each patient, using just one
urine sample, can firstly rule out those who do not have cancer, then accurately identify those with cancer and
finally, segregate out those with high-impact tumours for priority investigation. This approach provides significant
benefit to both physicians and patients, substantially reducing the number of patients requiring further work up
while prioritising those patients with high impact tumours.

“A significant outcome confirmed by this paper is the outperformance of Cxbladder used in this format where the
sequential use of the three Cxbladder tests achieved 4.8 times greater efficiency in accurately assigning patients to
the physician’s prioritisation of investigation, than the latest AUA guidelines. We expect this outcome to support
additional AUA guideline inclusion and greater adoption of Cxbladder.”

“A testament to the quality of this study (where the primary author is one of the key Kaiser Permanente’s
urologists), is that it shows the successful use of Cxbladder on Kaiser Permanente patients, supporting our now
established relationship with one of the US’s largest healthcare provider and payers.”

Feedback from the Journal’s independent peer reviewers during the publication process was very positive,
highlighting the potential for the study to “change the diagnostic paradigm for patients presenting with hematuria,
better identifying high-risk patients and decreasing the time to tumor diagnosis.”

Additionally, “This series of urine based tests appears to represent an exciting pathway for hematuria workups
better stratifying risk of malignancy, and perhaps obviating the need for cystoscopy in workup of many patients
with hematuria.”

Reviewers noted that “The study is novel, as results of CxbR have not been reported before (vs CxbT and CxbD).
Based on the high-negative predictive value achieved in the cohort, the purported clinical value of the study is to
allow clinicians to triage patients with high risk for expedited workup by sending them straight to transurethral
resection and avoiding cystoscopy and CT scans in those that are low priority.”

ENDS

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

For media assistance, please contact: Jackie Ellis, P: +64 27 246 2505 E: jackie@ellisandco.co.nz


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.

8 July 2021

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 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.