Pacific Edge Launches Cxbladder Resolve

Company Announcement
15 December 2016

PACIFIC EDGE LAUNCHES CXBLADDER RESOLVE - THE FOURTH PRODUCT IN SUITE OF CXBLADDER TESTS

Another step change for urologists and their patients

Cancer diagnostics company, Pacific Edge Limited (NZX: PEB) has today launched Cxbladder Resolve, the fourth product in the Cxbladder suite of bladder cancer diagnostic tests.

Cxbladder Resolve, a front line tool for urologists targeting the identification of patients with high grade and late stage disease, is now available to New Zealand urologists and will be progressively launched into other markets, including the USA, throughout 2017.

When haematuria (blood in the urine) is being first investigated, Cxbladder Resolve can be used to accurately identify those patients with high grade or late stage bladder cancer. This will allow those high risk patients to be fast-tracked for further clinical investigation and treatment.

Pacific Edge is the only company in the world to have a suite of molecular diagnostic tests in bladder cancer that addresses different needs throughout the diagnostic and treatment pathway - from investigation of haematuria through to the management of patients who have the disease and are coming back to the clinic for evaluation of the recurrence of bladder cancer. In these detection and management pathways, Cxbladder Triage is the first test used to rule out cancer in patients who have a low probability of having bladder cancer; Cxbladder Detect is used specifically to detect bladder cancer; while the new Cxbladder Resolve test segregates out those who have high grade or late stage cancer. All of these are carried out on a single, noninvasive, urine sample.

In addition, Cxbladder Monitor, which officially launched in the USA this month, has been designed to be used on patients as part of their ongoing surveillance regime to quickly and accurately identify those who have a low probability of having recurrent bladder cancer.

Bladder cancer is the ninth most prevalent cancer in the world, the fifth most prevalent cancer in the US and the fourth most prevalent cancer for men, with a very high recurrence rate in excess of 70%. However, this disease is highly treatable, especially if identified early. This makes timely diagnosis and earlier intervention, particularly for aggressive or advanced-stage tumours, a key element in the clinical process to improving patient outcomes.

CEO of Pacific Edge, David Darling, commented: “We are seeing growing demand from patients and physicians for our accurate, non-invasive, cost effective and simple to use ‘one stop shop’ of Cxbladder tests.

Cxbladder Resolve, our fourth product, fills another of the identified needs that the physicians have and will allow clinicians to fast-track those patients who the test identifies with high grade or late stage bladder cancer.

“A clinical evaluation has confirmed Cxbladder Resolve’s effectiveness in accurately identifying high grade cancer in haematuria patients with 96% sensitivity and 93% specificity. This is another high performance test for the urologist’s tool-box. We are looking forward to bringing this product to market and expect uptake from those healthcare providers already using our other tests, as well as new customers.

“Our goal is to provide a suite of tests that provides physicians with more accurate and effective detection and management options at all stages of the bladder cancer pathway. The launch of our fourth product, Cxbladder Resolve, further strengthens our Cxbladder offer”.

ENDS

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 haematuria 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 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.

© Scoop Media