Pacific Edge Trading Halt

PACIFIC EDGE TRADING HALT

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) has applied for and been granted a trading halt over its shares on the NZX and ASX.

The trading halt will remain in place until the earlier of the commencement of trading on Wednesday 7 June 2023 or the release of an announcement addressing the finalization over the weekend of a Local Coverage Determination (LCD) detailing the proposed ceasing of reimbursement of Cxbladder by Medicare in the US.

The LCD from Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s US laboratory, notes Cxbladder tests Triage, Detect, Monitor, Resolve and Detect+ are ‘not considered medically reasonable and necessary’, the threshold required for coverage under the US Social Security Act.

Pacific Edge requested, and was granted, the trading halts on the NZX and ASX to provide the Company time to better understand the implications of the LCD, and consult with our US legal advisors and other industry participants, before providing an update to all stakeholders.

Pacific Edge expects to provide the announcement before trading opens on Wednesday 7 June 2023 and will host a conference call on the announcement at 11am. Conference call details below:

Webcast link: www.virtualmeeting.co.nz/pebjun23
Phone participation: NZ: 0800 449 170; AUS 1800 896 574

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 is reimbursed by CMS and 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