Cxbladder Monitor Significantly Outperforms All Compared FDA Approved Urine Tests For Bladder Cancer; Enhancing The Standard Of Care For Bladder Cancer Patients

DUNEDIN, New Zealand, April 12, 2017 /PRNewswire/ -- Pacific Edge is proud to announce that its recent clinical study on Cxbladder Monitor's clinical performance and utility has been published in the prestigious international journal, Urologic Oncology. The peer reviewed scientific and clinical paper validates the superior performance of Pacific Edge's Cxbladder Monitor test for the surveillance of patients who are being managed for recurrence following treatment for bladder cancer, compared to existing alternatives. 

The published study, titled, "Clinical Comparison of Non-invasive Urine Tests for Ruling Out Recurrent Urothelial Carcinoma of the Bladder", compared the performance of Cxbladder Monitor to other commonly available urine biomarker tests and cytology for the surveillance of patients with urothelial carcinoma (bladder cancer).  The large clinical study evaluated more than 1100 U.S. patient samples against cytology and some commonly used U.S. Food and Drug Administration (FDA)-approved urine-based monitoring tests currently available.

Cxbladder Monitor demonstrated significant performance advantages over cytology and the urine-based monitoring tests, NMP22 ELISA, NMP22 BladderChek, and UroVysion® FISH, in a representative population undergoing surveillance for recurrent urothelial carcinoma¹. These results support the use of Cxbladder Monitor as a confirmatory negative adjunct to cystoscopy or to justify postponing cystoscopic investigations in select patients. The paper concluded that this performance signals a step change in clinical utility for urologists managing patients in a surveillance regime for recurrence of the disease.

The paper also concluded that Cxbladder Monitor provides clinicians with a greater degree of certainty when monitoring for recurrent bladder cancer, or when used as a direct rule-out test for patients identified as being low risk for recurrent disease, thereby avoiding cystoscopies in those patients that have a negative Cxbladder Monitor result.

Major limitations which other existing urine tests currently face are also described in the published study.   One of the key limitations of these alternatives is poor sensitivity, particularly for early-stage and low-grade tumors, which accounts for a significant proportion of recurrences in bladder cancer patients.  Cxbladder Monitor combines high sensitivity with high Negative Predictive Value (NPV), both of which are essential for an effective rule-out test.  The combination enables Cxbladder Monitor to outperform all comparator tests irrespective of the patient's age and gender, recurrent tumor size, stage and grade, or duration post-treatment with adjuvant BCG.

Jackie Walker, Chief Executive Officer of Pacific Edge Diagnostics USA, commented, "Cxbladder Monitor has been highlighted in this journal for its outstanding performance in the surveillance for recurrence of bladder cancer. Overall, it offers an 'increase in clinical utility warranting consideration for inclusion in the guidelines'. As stated in the paper, Cxbladder Monitor 'significantly outperforms current FDA-approved, compared, urine tests used in the management of bladder cancer'."

David Darling, Chief Executive Officer of Pacific Edge, added, "Cxbladder Monitor provides an opportunity to improve the standard of care for bladder cancer patients, making surveillance of patients with this disease and the monitoring for the recurrence of the disease more effective and, importantly for the patient, less invasive. The paper supports our strategy to provide a family of high performance bladder cancer products designed to meet targeted clinical needs."

The peer-reviewed paper will be published in the online edition of Urologic Oncology, which provides practical, timely, and relevant clinical and basic science information to physicians and researchers practicing urology worldwide. The print copy publication will be available in the following edition of the journal. It follows the recently announced publication of a separate large validation study of Cxbladder Monitor in The Journal of Urology, the scientific journal of the American Urological Association (AUA).

The Cxbladder Monitor test, with a sensitivity of 0.93 and Negative Predictive Value (NPV) 0.97, was launched in New Zealand in December 2015, and in the U.S. in December 2016 following the acceptance for publication of the Cxbladder Monitor clinical validation study in The Journal of Urology. It is the third of Pacific Edge's cancer diagnostic tests, as the Company continues to build its portfolio of accurate and non-invasive cancer diagnostic tests. 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; and Cxbladder Monitor provides urologists and patients with an accurate, non-invasive test to monitor this highly recurrent 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. 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.

¹ Study Results: The sensitivity of Cxbladder Monitor (0.91) significantly outperformed cytology (0.20), NMP22® enzyme-linked immunosorbent assay (0.26) and NMP22® BladderChek® (0.11). The negative predictive value of Cxbladder Monitor was also superior at 0.96 compared with cytology (0.87), NMP22® enzyme-linked immunosorbent assay (0.87), NMP22® BladderChek® (0.86). UroVysion® FISH also had inferior sensitivity (0.36) and negative predictive value (0.92) compared to Cxbladder Monitor. All false negative results (n=14) observed using Cxbladder Monitor were also negative for cytology, NMP22® enzyme-linked immunosorbent assay and NMP22® BladderChek®, and UroVysion® FISH.

SOURCE Pacific Edge Limited

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