25 October 2016
CXBLADDER MONITOR ADOPTED BY WAITEMATA DISTRICT HEALTH BOARD
Cxbladder Monitor to replace cystoscopy in clinical evaluation for low risk
surveillance patients
Cancer diagnostics company, Pacific Edge Limited (NZX:PEB), has received
approval for its latest Cxbladder diagnostic technology, Cxbladder Monitor,
from Waitemata District Health Board (WDHB) through the national procurement
services of healthAlliance.
Under the WDHB program, selected low risk patients who are undergoing routine
surveillance following a previous diagnosis and treatment for bladder cancer
will receive a Cxbladder Monitor test. If the test rules out bladder cancer,
it means these patients will not require a clinic appointment or have to
undergo an invasive cystoscopy procedure.
Brent Pownall, Commercial Director of Pacific Edge Diagnostics, said: "This
is another significant achievement for Pacific Edge. To have our newest
product, Cxbladder Monitor, adopted so readily at Waitemata DHB, and patients
to potentially be spared from undergoing a cystoscopy, is huge. The positive
impact of this initiative, demonstrated by the urology team at North Shore
Hospital in changing their approach to managing this group of surveillance
patients, cannot be underestimated."
Dr Madhu Koya, Clinical Director of Urology at Waitemata DHB said: "The
approach we are taking with Cxbladder is about ensuring that we deliver the
best possible care for our patients and clients, living our values of
compassion, connectedness, continuous improvement and leadership. In this
case, we have adopted the cutting edge Cxbladder Monitor test to improve the
lives of some of our bladder cancer surveillance patients with this simple to
use, non-invasive urine test. This avoids the inconvenience and anxiety of a
visit to the hospital clinic, and the invasive cystoscopy that goes with it,
and provides the peace of mind that there is no recurrence of the disease.
This is all about what is best for the patient."
"We have been involved in the clinical evaluation of the Cxbladder products
over a number of years. We trialled Cxbladder Monitor with patients and in
our clinics soon after it launched and quickly recognised its utility in
allowing us to change how we manage our low risk bladder cancer patients for
follow up, while at the same time improving their care with this convenient
urine test," Dr Koya said.
Cxbladder Monitor, which was launched in New Zealand in December 2015,
combines both genotypic biomarkers from a small quantity of a patient''s urine
and patient clinical information to accurately identify those patients who
have a low probability of having recurrent urothelial carcinoma (UC), or
bladder cancer. Results from clinical trials showed a high test sensitivity
and high negative predictive value for Cxbladder Monitor, required to
accurately rule out a recurrence of UC. The initial trial results also
demonstrated superior performance over all other urine-based tests and were
presented at the American Urological Association''s 2016 Annual Meeting in
May, in San Diego, CA.
CEO of Pacific Edge, David Darling, commented: "This highlights the value in
our approach to developing a suite of Cxbladder products that address
multiple needs across the entire diagnostic, treatment and management pathway
for bladder cancer. Pacific Edge now has all of its current Cxbladder tests
being deployed in a wide variety of clinical settings, and in multiple
markets - the company is now truly a ''one stop shop'' of bladder cancer
detection and management tests."
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. 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 hematuria
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 physicians
and 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:00291408 For:PEB Type:GENERAL Time:2016-10-25 14:35:10