Results Outperform Currently Available Tests for Monitoring Recurrent
Urothelial Carcinoma
Abstract Selected for Plenary Session at AUA 2016
DUNEDIN, New Zealand and HERSHEY, Pa., May 16, 2016
Cancer diagnostics company, Pacific Edge Limited (NZX:PEB), announced today
the presentation of positive results from a prospective multicenter, blinded
study of Cxbladder Monitor(TM), 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.
ENDS
For more information, please contact:
David Darling
Chief Executive Officer, Pacific Edge Ltd
P: +64 (3) 479 5800
Media Enquiries:
Jackie Ellis, Ellis and Co
P: +64 9 360 8500
jackie@ellisandco.co.nz
End CA:00282453 For:PEB Type:GENERAL Time:2016-05-16 13:47:03