Clinical study supports adoption of Cxbladder

24 June 2019

CLINICAL STUDY SUPPORTS ADOPTION OF CXBLADDER INTO NEW CLINCAL PATHWAY
Canterbury DHB publishes real-world clinical study with cementing evidence supporting the adoption of
Cxbladder into the new clinical pathway

The latest published clinical paper for Pacific Edge’s Cxbladder bladder cancer tests reveals the cementing evidence
behind the introduction of new guidelines for the assessment of haematuria
1
by one of New Zealand’s largest public
healthcare providers, Canterbury District Health Board (DHB).

The independent, real-world study has highlighted the benefits of using Cxbladder Triage (CxbT) in conjunction with
imaging for initial assessment of all patients that present to the clinic with haematuria for investigation for bladder
cancer. The results show that this new clinical process would allow approximately one-third of patients to be managed
within the community by the primary care provider, avoiding the need for an invasive and expensive cystoscopy.

The majority of haematuria patients treated in secondary care within the New Zealand health system are seen through
publicly funded hospitals and out-patient clinics (with access to services tightly managed to capacity using strict criteria
and careful review of referrals), supported in the community by a robust and competent primary care sector.

The 13-month study by Canterbury DHB of 571 patients with haematuria, looked to examine the performance of new
guidelines, that included CxbT as the only urine test to be used in combination with imaging, to the clinical pathway for
investigating haematuria.

The results were published in the New Zealand Medical Journal
2
and provide compelling evidence supporting the
adoption of Cxbladder into Canterbury DHB’s new clinical pathway.

In the look-back study, all significant bladder cancers were diagnosed by the new guidelines, combined use of imaging
and CxbT, before cystoscopy was undertaken, provided a performance with sensitivity of 97.7% and a negative
predictive value (NPV) of 99.8%.

This look-back study concluded that:
• The new proposed clinical pathway has the potential to save considerable amounts of physician and clinical
resources without compromising patient safety.
• The high negative predictive value (NPV) of this new clinical pathway would allow approximately one-third of
patients with haematuria to be managed without cystoscopy, a net cost saving of approximately 30% of
cystoscopies.
• Those patients with a negative CxbT test score could remain in primary care without being referred to secondary
care for specialist review thereby freeing up secondary care resources.
• Canterbury DHB estimated that this would free up approximately 200 patient consultations per year and allow
management of conditions that might not otherwise reach the thresholds for referral.
• Importantly, patients with haematuria would also safely avoid the social disruption and discomfort of a
secondary care clinic visit for cystoscopy.
• The new pathway should be applicable in any health system with effective general practice or primary care and
the ability to inform GPs of locally recommended assessment and management of haematuria.


1
Haematuria is blood in the urine and a key indicator of urothelial and bladder cancer.
2
NZMJ 21 June 2019, Vol 132 No 1497 ISSN 1175-8716 © NZMA http://www.nzma.org.nz/journal/read-the-journal/all-
issues/2010-2019/2019/vol-132-no-1497-21-june-2019/7915

24 June 2019
The findings have resulted in the adoption of new local guidelines for all Canterbury DHB haematuria patients, which
require that patients who present to their primary care physician in the first instance, receive CxbT and imaging. Patients
negative to CxbT and imaging will not now progress to secondary care with its invasive and expensive treatment options.

This new haematuria assessment algorithm was adopted into the Canterbury Community Health Pathways in February
2018 and continuous audit of a further 890 patients has been carried out over the last year to provide a further look-
back on utility, performance and patient compliance and safety.

CEO of Pacific Edge, David Darling, said: “The Canterbury DHB look-back study should be essential reading for all large
healthcare organisations which are looking to better allocate limited resources and ensure quality patient care. A rapidly
growing library of clinical evidence demonstrating the benefits and clinical utility of our Cxbladder tests is being published
in respected medical journals, and key opinion leaders are supporting the use of Cxbladder in clinical settings. For a
cancer diagnostics company commercialising new medical technology, such as Pacific Edge, the long and arduous
pathway to peer reviewed publications provides the lifeblood in achieving clinical acceptance and positive
reimbursement outcomes for our products.”

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 non-invasive, simple
to use and accurate Cxbladder tests enable the detection of bladder and other urinary tract cancers from a small volume of a
patients’ urine. Cxbladder provides actionable results and better detection and management of urothelial cancer. The company
is developing and commercialising its range of Cxbladder tests globally and has two wholly owned accredited laboratories in
New Zealand and the USA. The company’s products have been tested and validated in multiple international clinical studies.

ABOUT Cxbladder Triage
Cxbladder Triage accurately identifies 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 cancer.

ABOUT Cxbladder Detect
Cxbladder Detect provides clinicians with a quick, cost effective and accurate measure of the presence of the cancer as an
effective adjunct to cystoscopy. Is often used in conjunction with Cxbladder Triage to provide greater rule-out and resolution
of patients who have UC.

ABOUT Cxbladder Monitor
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 whose Cxbladder Monitor score shows that they have a low probability of recurrent urothelial
cancer. 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.

24 June 2019
ABOUT Cxbladder Resolve
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.