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Journal of Urology publishes outperformance of Cxbladder

Operational Update18 August 2021PEBHealthcare

Company Announcement
18 August 2021



THE JOURNAL OF UROLOGY PUBLISHES OUTPERFORMANCE OF CXBLADDER IN USA

COVID19 SETTING


The American Urological Association’s (AUA) Journal of Urology has published the real world lookback highlighting

the clinical utility of Cxbladder being used in the Covid setting for managing patients outside the clinic. The lookback

study concluded that the use by physicians of Cxbladder Monitor and Pacific Edge’s Patient-In-Home Sampling

System reduced the number of cystoscopies required and was feasible and safe for patients being monitored for

urothelial cancer during the Covid-19 pandemic. In addition, the study concluded that Cxbladder could be used to

further stratify low risk patients for decreased surveillance during the pandemic and beyond.


The evaluation and lookback was performed by the University of California San Francisco (UCSF) on a cohort of 52

patients who were being monitored for urothelial cancer as part of their standard of care. Cxbladder Monitor

correctly identified those at high risk who immediately underwent cystoscopy. Those patients with low Cxbladder

Monitor scores were deemed to be low risk and their cystoscopies were deferred to their next scheduled

surveillance visit. The follow-up surveillance cystoscopy for these patients, showed no suspicious tumors and no

positive cytology was detected. Cxbladder Monitor missed no tumors and among those detected, a number were

high impact tumors.


CEO of Pacific Edge, David Darling, said: “This latest published evidence provides a real-world insight into the

effectiveness of Cxbladder in helping manage patients who can’t come in to the clinic. It is great to see our Patient

In-Home Sampling System (PIHSS) being used with such great effect and such compelling results.


“The COVID-19 pandemic has brought unprecedented changes to the provision of urologic care in order to minimise

risks of transmission. Advances in telemedicine look to be providing a new paradigm for healthcare and Cxbladder

and our patient in home sample system are well positioned to continue as an integral part in the detection and

management of patients with urothelial cancer.”


The clinical paper was authored by Carrisa Chu, Kevin Li, Maxwell Meng and Sima Porten and published in the

September 2021 issue of the Journal of Urology:

PD63-12:USE OF CXBLADDER MONITOR DURING THE COVID-19 PANDEMIC TO REDUCE THE FREQUENCY OF

SURVEILLANCE CYSTOSCOPY


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

Company Announcement
18 August 2021

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

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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