PEB
11/08/2015 10:05
GENERAL
NOT PRICE SENSITIVE
REL: 1005 HRS Pacific Edge Limited
GENERAL: PEB: PE's NZ Lab Gains CLIA Approval for Cxbladder Triage Test
11 August 2015
Pacific Edge's New Zealand laboratory gains CLIA approval for Cxbladder
Triage test
Cancer diagnostic specialist Pacific Edge today advised it has gained
regulatory approval from the USA regulatory authority CLIA (Clinical
Laboratory Improvement Amendments) to enable the commercial use of its
Cxbladder Triage test from its diagnostics laboratory in Dunedin.
The approval from CLIA is the registration standard for any laboratory
processing of Laboratory Developed Tests (LDT). This is mandatory for
processing any samples originating from patients within the United States or
its territories.
Pacific Edge Chief Executive Officer, David Darling, says: "This is an
important step for the commercial application of Cxbladder Triage.The
approval means that Cxbladder Triage test samples can now be commercially
processed at our Dunedin laboratory and offered to markets that recognise the
CLIA regulatory approval. It also complements the approval we have gained for
the Cxbladder Detect test."
Cxbladder Triage is Pacific Edge's newest product to enter the commercial
market and offers physicians an accurate test to triage out those patients
who present with haematuria who have a low probability of having urothelial
carcinoma.
The Dunedin laboratory processes samples obtained from patients in New
Zealand as well as all samples for clinical or in market studies and User
Programs.
CLIA sets standards and issues certificates for clinical laboratory testing
of Laboratory Developed Tests (LDT) in the United States. It is administered
by the US government agency, Centre for Medicare and Medicaid Services, CMS.
Only one other laboratory in Australasia is believed to have CLIA
registration with most CLIA registered laboratories operating in the United
States and its associated territories.
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
ABOUT Cxbladder Triage
Cxbladder Triage is a proprietary molecular test that combines the power of
the genomic biomarkers with extra phenotypic and clinical risk factors to
accurately identify and remove patients with hematuria who have a low
probability of bladder cancer, from needing to have a full-urological
work-up. This is a tool for use by clinicians and physicians in the primary
evaluation and is intended to reduce of the number of patients needing an
expensive and invasive work-up for urothelial cancer.
www.cxbladder.com
ABOUT Cxbladder Detect
Cxbladder Detect is a proprietary, accurate molecular diagnostic test that
enables the non-invasive detection of bladder and other urinary tract cancers
from a small volume of urine. Cxbladder Detect is commercially available in
New Zealand, Australia and the USA. Cxbladder Detect is available in the USA
and NZ as a Laboratory Developed Test (LDT) from the company's CLIA certified
laboratories, providing physicians and clinicians with a quick, cost
effective and accurate measure of the presence of the cancer, and provides
urologists with an effective adjunct to cystoscopy. The Cxbladder Detect
cancer detection test has been validated by a multi-centre, international
clinical study.
www.cxbladder.com
ABOUT Bladder Cancer
Globally, bladder cancer has the 9th highest incidence and the 4th highest
incidence for men. One of the early symptoms of bladder cancer is the
presence of blood in the urine, haematuria. People with haematuria often
present to their general practitioner before being referred on to a
urologist. Bladder cancer has a very high recurrence rate of approximately
50%-70% with up to 30% of these recurring as later stage tumours. However,
bladder cancers are highly treatable, especially if detected in the early
stages when there is a much higher probability of survival. Timely detection
and regular surveillance and monitoring of this cancer is a key element of
the clinical process and of the individual's annual healthcare plan.
ABOUT Pacific Edge
Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic
company specialising in the discovery and commercialisation of diagnostic and
prognostic technology for the early detection and monitoring of cancer. The
company is developing and commercialising its range of Cxbladder bladder
cancer tests. It's first commercial product, Cxbladder Detect, is now being
actively marketed to physicians and clinicians in New Zealand, Australia, and
the USA through the company's wholly owned subsidiaries and selected
commercial partners.
www.pacificedge.co.nz www.pacificedgedx.com
End CA:00268208 For:PEB Type:GENERAL Time:2015-08-11 10:05:28
