NEW YORK (GenomeWeb) – A recently published study by researchers from New Zealand-based diagnostic firm Pacific Edge and collaborators has shown that the firm’s molecular diagnostic test for bladder cancer recurrence, Cxbladder Monitor, outperforms cytoscopy and other commonly used US Food and Drug Administration-approved urine-based tests for bladder cancer monitoring.
The study, published in late April in Urologic Oncology,concluded that the test provides clinicians with a “confirmatory negative adjunct to cystoscopy” or justification to postpone a cystoscopy when monitoring for recurrent bladder cancer in low-risk patients. The paper also follows on the heels of a company-led prospective validation of the assay published in December in the Journal of Urology.
Together, the studies provide compelling evidence regarding the clinical utility of Cxbladder Monitor, which hit the US market as a laboratory-developed test in December 2016 after being launched in New Zealand a year earlier.
Pacific Edge is headquartered in Dunedin and also has a CLIA-certified, CAP-accredited lab facility in Hershey, Pennsylvania, where a 20-person sales team markets its products directly to urologists. The company also has a CLIA laboratory in Dunedin, and has commercial operations in Singapore and Australia.
Cxbladder Monitor is the third of four tests in the company’s portfolio