DUNEDIN, New Zealand and HERSHEY, Pa., May 16, 2016 /PRNewswire/ -- Cancer diagnostics company, Pacific Edge Limited (NZX: PEB), announced today the presentation of positive results from a prospective multicenter, blinded study of Cxbladder Monitor™, the Company's new urine-based gene expression test for the investigation of urothelial carcinoma (UC) in patients presenting for monitoring of recurrent disease.
The abstract #745, titled, "The Development and Clinical Validation of a High Sensitivity Urine biomarker test for the Determination of Recurrence in Urothelial Carcinoma Patients," was presented by Yair Lotan, M.D., of the University of Texas Southwestern Medical Center at Dallas, in a plenary session at the American Urological Association (AUA) 2016 conference in San Diego, CA.
The study was designed to develop, optimise and validate performance characteristics of Cxbladder Monitor and compare them to those of existing urine detection tests used in the evaluation and monitoring of patients for recurrence of the UC.
Results presented at the plenary session demonstrate that Cxbladder Monitor is an effective rule out test with a sensitivity of 93% and a negative predictive value of 97%, significantly outperforming all other existing urine-based tests evaluated across all stages and grades of tumor.
The prospective, blinded clinical study was conducted across 11 clinical sites across the United States. 1117 samples were collected from a large representative population of 803 patients presenting for the investigation of recurrent UC. Patients in the study were then monitored for either six months or a maximum of three cystoscopic evaluations, the gold standard for diagnosing recurrent UC.
Dave Darling, Chief Executive Officer of Pacific Edge, stated, "Cxbladder Monitor will provide urologists with greater certainty of their clinical evaluations, and patients with a non-invasive way to monitor their disease. The impressive results that were presented by Dr. Lotan enable physicians to rule out those patients with a low probability of having recurrent disease and obviate the need for other urine diagnostic tests.
"Cxbladder Monitor greatly reduces the burden of cystoscopy on low-risk patients who are scheduled for clinical evaluation or can be used as a confirmatory negative adjunct to cystoscopy, thereby justifying the postponement of additional investigation."
Cxbladder Monitor was released in December 2015 as the third product in the Cxbladder suite of tests for the detection and management of bladder cancer, the ninth most prevalent form of cancer. Currently available in New Zealand, Pacific Edge plans to begin marketing Cxbladder Monitor in the United States later this year.
About Pacific Edge Limited
Pacific Edge Limited (NZX: PEB) is a New Zealand publicly listed, cancer diagnostic company specializing in the discovery and commercialization of diagnostic and prognostic tests for better detection and management of cancer. The company is developing and commercializing 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 multicenter 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 is available through the company's dedicated CLIA certified laboratories for customers in New Zealand, Australia and the USA. Cxbladder Triage is available in New Zealand and Australia. Cxbladder Monitor launched in New Zealand in December 2015 and is anticipated being available in the US in 2016.
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SOURCE Pacific Edge Limited