News Feed Item

U.S. Grants Pacific Edge Patent for Melanoma Detection

DUNEDIN, New Zealand and HERSHEY, Pa., Sept. 4, 2014 /PRNewswire/ -- The United States Patent and Trademark Office has granted Pacific Edge Limited, a cancer diagnostics company, U.S. Patent Number 8,822,149 covering "Prognosis Prediction for Melanoma Cancer." The patent covers the technology being used to develop a melanoma prognostic test that will enable clinicians to distinguish aggressive and life threatening melanomas from those that are not as aggressive.

Pacific Edge Diagnostics USA Logo.

"It is the aggressive tumours that will kill you," Pacific Edge Chief Executive Officer David Darling said.

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 its prototype product for detecting aggressiveness in Stage III melanomas.

The United States is the third jurisdiction after China and New Zealand to grant patent protection for the 'Prognosis Prediction for Melanoma' test, which 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 focusing 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," Mr. Darling said.

"Cxbladder is a prime example of our development efforts. 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 physicians and clinicians to segregate out patients who have presented to the clinician with blood in their urine, but 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 intellectual property portfolio 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 United States, into other products for that market. We are also now looking to other targeted international markets," David Darling commented.

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.  For more information, please visit http://www.cxbladder.com

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.

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. For more information, please visit http://www.pacificedge.co.nz

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. For more information, please visit http://www.pacificedgedx.com

For more information contact:

David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800

Logo - http://photos.prnewswire.com/prnh/20131015/MM98246LOGO

SOURCE Pacific Edge Diagnostics USA LTD

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Enterprises have been using both Big Data and virtualization for years. Until recently, however, most enterprises have not combined the two. Big Data's demands for higher levels of performance, the ability to control quality-of-service (QoS), and the ability to adhere to SLAs have kept it on bare metal, apart from the modern data center cloud. With recent technology innovations, we've seen the advantages of bare metal erode to such a degree that the enhanced flexibility and reduced costs that cl...
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of So...
Intelligent machines are here. Robots, self-driving cars, drones, bots and many IoT devices are becoming smarter with Machine Learning. In her session at @ThingsExpo, Sudha Jamthe, CEO of IoTDisruptions.com, will discuss the next wave of business disruption at the junction of IoT and AI, impacting many industries and set to change our lives, work and world as we know it.
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, discussed the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filterin...
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
In his session at Cloud Expo, Robert Cohen, an economist and senior fellow at the Economic Strategy Institute, will provide economic scenarios that describe how the rapid adoption of software-defined everything including cloud services, SDDC and open networking will change GDP, industry growth, productivity and jobs. This session will also include a drill down for several industries such as finance, social media, cloud service providers and pharmaceuticals.
DevOps is speeding towards the IT world like a freight train and the hype around it is deafening. There is no reason to be afraid of this change as it is the natural reaction to the agile movement that revolutionized development just a few years ago. By definition, DevOps is the natural alignment of IT performance to business profitability. The relevance of this has yet to be quantified but it has been suggested that the route to the CEO’s chair will come from the IT leaders that successfully ma...
We are always online. We access our data, our finances, work, and various services on the Internet. But we live in a congested world of information in which the roads were built two decades ago. The quest for better, faster Internet routing has been around for a decade, but nobody solved this problem. We’ve seen band aid approaches like CDNs that attack a niche's slice of static content part of the Internet, but that’s it. It does not address the dynamic services-based Internet of today. It doe...
Ask someone to architect an Internet of Things (IoT) solution and you are guaranteed to see a reference to the cloud. This would lead you to believe that IoT requires the cloud to exist. However, there are many IoT use cases where the cloud is not feasible or desirable. In his session at @ThingsExpo, Dave McCarthy, Director of Products at Bsquare Corporation, will discuss the strategies that exist to extend intelligence directly to IoT devices and sensors, freeing them from the constraints of ...
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
By now most people have either created their configuration management solution or are just embarking on this journey. In his session at @DevOpsSummit at 19th Cloud Expo, Marco Ceppi, a DevOps Engineer working at Canonical, will discuss how to take configuration management to the next level with modelling and orchestration. He will also discuss how and why people are moving from a machine-centric view to a service/application-oriented view of deployments, and how you can leverage the knowledge a...
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
In the 21st century, security on the Internet has become one of the most important issues. We hear more and more about cyber-attacks on the websites of large corporations, banks and even small businesses. When online we’re concerned not only for our own safety but also our privacy. We have to know that hackers usually start their preparation by investigating the private information of admins – the habits, interests, visited websites and so on. On the other hand, our own security is in danger bec...