Cxbladder™ Monitor Demonstrates Clinical Utility In Patients Being Monitored For Recurrent Bladder Cancer (UC)

DUNEDIN, New Zealand, May 24, 2018 /PRNewswire/ -- The addition of Cxbladder Monitor for bladder cancer surveillance has been shown to enable physicians to reduce the overall number of diagnostic tests being ordered, potentially reducing the total cost of monitoring and reducing complications related to unnecessary tests.

The recent published study highlights the clinical utility of Pacific Edge's non-invasive cancer diagnostic test, Cxbladder Monitor, with results showing a significant reduction in the number of tests ordered by physicians when using Cxbladder Monitor for the detection or rule-out of recurrent urothelial cancer^1.

CEO of Pacific Edge, David Darling, said: "Changing clinical behavior is not simple, however, in this study, overwhelmingly, clinicians made significant changes and reallocations of their diagnostic procedures when provided with the Cxbladder Monitor results. These findings are of material importance to all clinicians involved in the diagnosis of bladder cancer and are of particular relevance to payers and funders of healthcare, such as the Centers for Medicare and Medicaid."

Participant physicians in the US evaluated the real-world clinical data for patients undergoing surveillance for recurrent urothelial cancer, generating a total of 828 physician-patient decisions. The study evaluated the number and type of tests and procedures ordered and their changes in timing,  both before and after disclosure of Cxbladder Monitor results.

The addition of Cxbladder Monitor to the physicians' decision making resulted in significant reduction in both the total number of tests and the number of invasive tests ordered by physicians.

For patients whose Cxbladder Monitor result showed a low probability of recurrent cancer, the number of tests ordered by physicians was reduced by 38.7%, including a reduction in invasive cystoscopy procedures of 43%.  For those patients with an elevated probability result, the number of procedures ordered was consistent with the increased risk of recurrent cancer, and invasive procedures were ordered in a more targeted fashion without compromising detection.

Jackie Walker, CEO of Pacific Edge's USA business commented: "This latest study builds on the body of published evidence that demonstrates the benefits of our Cxbladder suite of tests. Cxbladder provides solutions that not only improve the patients' clinical experience and enhance their outcome, but also enable the appropriate allocation of diagnostic procedures, particularly expensive and invasive procedures. There is also the potential for a significant reduction in the total cost to healthcare payers by reducing the number of diagnostic procedures required."

There are approximately 79,000 new cases of urothelial cancer, including bladder cancer, diagnosed in the United States annually and a total of approximately 800,000 patients being monitored for recurrence of the disease annuallyⁱ. While treatable, urothelial cancer has one of the highest recurrence rates of any cancer and patients undergo a rigorous surveillance program. Consequently, in the US it is the most expensive cancer to diagnose, treat and monitor per patient lifetime, with an estimated cost of US$5.25 billion by 2020ⁱⁱ.

Clinical and scientific papers such as these are an important part of Pacific Edge's commercial strategy and essential in validating its products with major healthcare providers and funders in the United States, which is the company's primary focus. This study has recently been published in Oncology and Therapy (https://doi.org/10.1007/s40487-018-0059-5)

Cxbladder Monitor has a sensitivity of 0.93 and Negative Predictive Value (NPV) of 0.97. It is the third of Pacific Edge's suite of Cxbladder cancer diagnostic tests available for use by US physicians:

• Cxbladder Triage helps to rule out cancer in patients who have a low probability of having urothelial cancer
• Cxbladder Detect is used specifically to detect bladder cancer
• Cxbladder Monitor provides urologists who are evaluating patients for the recurrence of the disease with greater certainty of their clinical evaluations, and patients with a non-invasive way to monitor their disease.

For more information contact:

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

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. Its Cxbladder suite of non-invasive, simple to use and accurate diagnostic tests provide actionable results, and better detection and management of urothelial 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.

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 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 allows urologists to monitor bladder cancer patients for recurrence of the disease. 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.

ABOUT Cxbladder Resolve www.cxbladder.com 
Cxbladder Resolve identifies those patients who are likely to have aggressive or more advanced bladder cancer. Cxbladder Resolve, when used as part of the primary evaluation of haematuria and/or in conjunction with other Cxbladder tests (Triage, Detect), is designed to assist clinicians by accurately identifying patients with a high probability of having high grade or late stage bladder cancer, for whom alternative or expedited treatment options may be warranted, or who can be prioritised for further investigation in high throughput settings.

Refer to www.cxbladder.com for more information.

¹ Clinical utility refers to a demonstration of a test's ability to provide actionable information for a clinician to use in patient management, including the ability to positively affect clinical decisions and improve outcomes for patients and the healthcare system.
ⁱ American Cancer Society. What are the key statistics about bladder cancer? [Internet]. https://www.cancer.org/cancer/bladder-cancer/about/key-statistics. html. Updated January 5, 2017. Accessed 14 Sept 2017.
ⁱⁱ Yeung C, Dinh T, Lee J. The health economics of bladder cancer: an updated review of the published literature. PharmacoEconomics. 2014;32:1093–104.

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SOURCE Pacific Edge Limited