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(R) FISH, in a large representative population
undergoing surveillance for recurrent urothelial carcinoma. 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''.
"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 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.
End CA:00297856 For:PEB Type:GENERAL Time:2017-03-06 10:20:09