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Pacific Edge Diagnostics Receives Medicare Coverage for Bladder Cancer Test

NEW YORK – Cancer diagnostic company Pacific Edge Diagnostics announced Monday that its Cxbladder test is covered under Medicare Administrative Contractor Novitas' general local coverage decision for oncology biomarkers.

Novitas notified the firm of its coverage under the LCD, which covers a variety of oncology biomarkers used for diagnosis, classification, monitoring, surveillance, and prognosis. Biomarkers are covered under the LCD if they have proven clinical utility or validity; if there is uptake of specific testing into patient management; and if providers can demonstrate that use of the biomarkers will be used to help manage or treat the patient. For combination panels with multiple biomarkers, peer-reviewed full manuscript evidence is required.

New Zealand-based Pacific Edge Diagnostics' Cxbladder test is a urine-based assay for the diagnosis and management of bladder cancer. In the US, National Comprehensive Cancer Network guidelines have recognized it as an appropriate diagnostic test for the monitoring for recurrence of bladder cancer, the firm said in a statement. 

The test can be used for patients presenting with hematuria or for patients already diagnosed with bladder cancer under surveillance for recurrence. Cxbladder is covered for use on or after July 1.