PEB
04/09/2014 11:55
GENERAL
REL: 1155 HRS Pacific Edge Limited
GENERAL: PEB: US grants Pacific Edge patent for melanoma detection
US grants Pacific Edge patent for melanoma detection
4 September 2014
The United States Patent Office has granted Pacific Edge patent protection
for 'Prognosis Prediction for Melanoma'. The patent covers the technology
being used to develop the melanoma prognostic test that will enable
clinicians to distinguish aggressive and life threatening melanomas from
those that are not as aggressive.
"It is the aggressive tumours that will kill you" Pacific Edge Chief
Executive Officer David Darling says.
The test applies a gene signature to a tissue sample taken from the melanoma
to detect its aggressiveness allowing clinicians to prescribe the appropriate
level of treatment. Specifically, the test in development identifies
aggressiveness in Stage III melanomas.
Pacific Edge partnered with the Ludwig Institute of Cancer Research, the
world's largest not-for-profit cancer research organisation, to develop the
technology. This successful partnership has enabled Pacific Edge to develop
the prototype product for detecting aggressiveness in Stage III melanomas.
The USA is the third jurisdiction after China and New Zealand to grant patent
protection for the 'Prognosis Prediction for Melanoma' test that is in the
development stage.
The melanoma test is one of several cancer products that the Company has
worked up to prototype level prior to focussing resources on the successful
launch and further development of its Cxbladder technology for detecting and
managing bladder cancer. Cxbladderdetect is now being commercialised in the
United States, New Zealand, Australia, and soon in Spain. The second product
in the program, Cxbladdertriage, is scheduled for commercial release in New
Zealand later this year.
Pacific Edge was founded to use the latest developments in molecular biology
to provide actionable diagnosis that can contribute to a clinically
meaningful difference in cancer detection and the management of that cancer.
It is the driving force of our research and product development program"
David Darling says.
"Cxbladder is a prime example. It is a quick, cost effective, non-invasive
and highly accurate cancer detection test that enables clinicians to detect
urothelial carcinomas, including cancers of the bladder, from a small urine
sample."
Pacific Edge's ongoing development program includes clinical and 'User
Programs' to validate Cxbladdertriage, a new product positioned to enable
physians and clinicians to segregate out patients who have presented to the
clinician with blood in their urine, who do not have bladder cancer thereby
saving considerable clinical work-up cost. Another of the Company's products
in late-stage development and validation is Cxbladderpredict, a product that
will enable clinicians to determine the severity of bladder cancer disease
and enable them to non-invasively segregate superficial tumours from invasive
tumours.
The Company's portfolio of intellectual property continues to grow and
includes patents for a gastric cancer test as well as melanoma and bladder
cancers.
"We are now leveraging the experience gained in launching Cxbladder to the
world's largest health care market, the USA, into other products for the USA.
We are also now looking to other targeted international markets" David
Darling says.
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
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.
Products in development and in clinical trials are accurate and simple to use
genomic and proteomic tools for the earlier detection, improved
characterisation and better management of gastric, bladder, colorectal
cancers and melanoma. The company has completed and released its first
product for the detection of bladder cancer, Cxbladder, and is actively
marketing the product to physicians and clinicians in New Zealand, Australia
and the USA and soon in Spain.
www.pacificedge.co.nz
ABOUT PACIFIC EDGE DIAGNOSTICS
Pacific Edge takes its exciting cancer detection tests to market through its
wholly owned subsidiaries, Pacific Edge Diagnostics NZ Ltd and Pacific Edge
Diagnostics USA Ltd, and selected commercial partners in Australia and Spain,
Healthscope and Oryzon respectively.
www.pacificedgedx.com
ABOUT Cxbladder
The Company's first product to reach the market is Cxbladder, 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 was commercialised in New Zealand and Australia in 2012 and the USA
in 2013 as a Laboratory Developed Test (LDT). It provides physicians and
clinicians with a quick, cost effective and accurate measure of the presence
of the cancer, and provides urologists with the opportunity to reduce their
reliance on the need for invasive tests such as cystoscopy. The Cxbladder
cancer detection test has been validated by a multicentre, international
clinical study. Results published in the Journal of Urology (Sept 2012) show
that Cxbladder out-performed all of the benchmark technologies in the
clinical trial and detected nearly all of the tumours of concern to a
urologist; At a performance of 82% sensitivity and 85% specificity the test
sees 100% of T1, 100% of T2, 100% of T3, 100% of Tis and 100% of upper
urinary tract cancers as well as greater than 95% of high grade tumours.
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.
There are a number of 'at risk' occupations that have shown a much higher
incidence of bladder cancer. Fire fighters and fire control officers have
shown in a US study to have a twice the incidence of bladder cancer over non
fire fighters. Smoking is a significant contributing factor (over 50% in
males and 33% in females, and approximately one of every two new incidences
of bladder cancer is linked to smoking). Exposure to certain industrial
chemicals or carcinogens increases risks for some occupations e.g.
hairdressers, painters, printers, fire fighters and metal workers and
chemical engineers. Incidence increases with age so the older you are, the
greater the potential for bladder cancer.
Bladder cancer has a very high recurrence rate of approximately 50%-70% with
up to 30% of these recurring as later stage tumours. This is a higher
recurrence than for skin cancer! However, bladder cancers are highly
treatable, especially if detected in the early stages. If diagnosed early
there is a much higher probability of survival for early stage tumours
relative to later stage tumours. This makes timely and regular surveillance
and monitoring of this cancer a key element of the clinical process and of
the individual's annual healthcare plan.
End CA:00254867 For:PEB Type:GENERAL Time:2014-09-04 11:55:09
