Pacific Edge (ASX:PEB, NZE:PEB) said a draft local coverage determination (LCD) establishing hematuria evaluation as a covered Medicare benefit has been published, with explicit coding guidance for its Cxbladder Triage and Triage Plus tests, according to a Friday Australia and New Zealand bourse filing.

The company said the draft LCD distinguishes hematuria patients as eligible for Cxbladder Triage and Triage Plus, contrasting with an existing non-coverage LCD for patients with cancer or substantiated suspicion of cancer.

"The draft LCD and LCA confirm our position as the first mover and market leader in non-invasive diagnostics for microhematuria patients suspected of bladder cancer, and Pacific Edge now stands on the cusp of a major commercial inflection point with the only two tests covered for microhematuria evaluation," said Chief Executive Peter Meintjes.

While an LCD, when finalized, directly enables reimbursement for over 66 million Medicare patients, the company said the draft coverage language also provides a template for US commercial payers covering 223 million patients, with the news expected to provide a tailwind to international market adoption, the filing added.

The draft LCD begins a notice and comment period of at least 45 days, with Novitas, a Medicare administrative contractor, required to publish a final version or withdraw the draft within 12 months, with the LCD becoming effective 45 days after finalization, it added.

The company's New Zealand shares rose 40% in recent Friday trade, their highest since May 2023.