25 September 2014
Japan grants Pacific Edge patent for colorectal cancer prognostic technology
The world’s second largest single biomedical market, Japan, has awarded Pacific Edge a patent for its colorectal cancer
prognostic technology. Pacific Edge Chief Executive Officer David Darling says the issue of the patent in Japan is a
significant step for the Company by providing intellectual property protection in the country where colorectal cancer is
the most prevalent cancer.
“Currently our focus is on accelerating the roll-out of the Company’s first commercial molecular diagnostic test,
Cxbladder Detect, in the USA, the world’s largest health care market. We are gaining commercial traction and as
milestones are attained there, the opportunity to launch the Cxbladder system into other markets and bring to market
further developments of our intellectual property, such as our colorectal cancer technology, become attractive.”
“We are on track to launch our second product, Cxbladder Triage, into the NZ market late this year. This is an exciting
time for Pacific Edge.”
Colorectal cancer is overall the most prevalent cancer in Japan, the second highest in men and third highest in women.
Its incidence in Japan has increased dramatically over the last 30 years which has been attributed to changing
lifestyles and diets.
Pacific Edge’s colorectal cancer prognostic technology is targeted to enable the detection of aggressive cancer in
patients already diagnosed with colorectal cancer. This prognostic test in development is expected to provide clinicians
with a significantly improved capability to determine the aggressiveness of Stage II and Stage III colorectal cancer.
The test results will enable clinicians to predict progression and provide patients with a more specific treatment
following surgery. Pacific Edge’s colorectal cancer prognostic gene signature is in late stage development and on
completion will become another commercial product for the Company, joining the Cx family as Cxcolorectal.
Presently, patients with Stage II disease are generally not treated with adjuvant chemotherapy as it is not possible to
identify the subset of patients who will have aggressive disease. In the five major European countries, the USA and
Japan, approximately 430,000 individuals are diagnosed with colorectal cancer every year. Of those diagnosed cases
approximately 280,000 patients are diagnosed with Stage II and Stage III progressions of the cancer. Approximately 30%
of the patients with Stage II and roughly 50% of those with Stage III experience disease progression including distant
metastasis of the liver and lung or local recurrence within three to five years after surgery. If the cancer spreads to
distant organs, the five-year survival rate for these patients is approximately 8% making the early detection of those
patients with an aggressive disease a significant medical opportunity for clinicians and patients. Cxcolorectal will
provide clinicians with a valuable tool to help identify those patients at greatest risk who will then be able to be
more appropriately targeted for adjuvant chemotherapy in addition to surgery.
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.
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.
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 outperformed 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.
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.
ENDS