The inclusion of Cxbladder Triage as the standard of care in an amendment to the American Urological Association’s clinical guideline for management of patients presenting with microhematuria has been described as a “significant milestone” for Pacific Edge.

As a result, the Dunedin-based cancer diagnostics company expected an uplift in demand for Cxbladder tests as more clinicians in the United States and around the world began to observe the updated guideline and incorporate the tests into care pathways.

In an update to the NZX, the company said it also expected to leverage the guideline language in its ongoing policy dialogue with Medicare Administrative Contractor Novitas and the Centres for Medicare and Medicaid services over the local coverage determination (LCD) released in January which threatened to end Medicare coverage of Cxbladder on April 24.

Under current legislation, MACs were required to consider consensus statements and/or guidelines in determining coverage.

Pacific Edge would inform Novitas of the new guideline and expected to use the AUA guideline and the evidence on which it was based for a formal reconsideration of the LCD.

— APL

 

Share.