Medicare LCD Effective Date Extended to 24 April 2025

MEDICARE LCD EFFECTIVE DATE EXTENDED TO 24 APRIL 2025

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) advises the date at which the ‘Genetic Testing in Oncology: Specific Tests’ (L39365) Local Coverage Determination (LCD) comes into effect has been extended by two months until Thursday 24 April 2025 (US time) from the original date of Sunday 23 February (US time).

The change in effective date was observed on Sunday morning NZT after an off-schedule update to the Medicare Coverage Database overnight. The update contains no explanation, but follows representations by Pacific Edge to Novitas, its parent company GuideWell, the Centers for Medicare & Medicaid Services (CMS), the US Department of Health and Human Services Office of the General Counsel (OGC), and incoming political leadership to have the LCD revised or withdrawn.

Pacific Edge will update shareholders as more information comes to hand.

Released for and on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.

For more information:

Investors:
Dr Peter Meintjes
Chief Executive
Pacific Edge
P: 022 032 1263

Media:
Richard Inder
The Project
P: +64 21 645 643

OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the development and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the USA.

Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance of bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes more than 20 peer reviewed publications for primary detection, surveillance, adjudication of atypical urine cytology and equivocal cystoscopy. Cxbladder is the focal point of numerous ongoing and planned clinical studies to generate an ever-increasing body of clinical utility evidence supporting adoption and use in the clinic to improve patient health outcomes. Cxbladder has been trusted by over 4,400 US urologists in the diagnosis and management of more than 100,000 patients, including the option for in-home sample collection. In New Zealand, Cxbladder is accessible to 75% of the population via public healthcare and all residents have the option of buying the test online.

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Announcement PDF