Medicare LCD Effective Date Extended to 24 April 2025

27 January 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
1
, 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LCD revised or withdrawn.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: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263
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

1
Novitas is the Medicare Administrative Contractor with responsibility for Pacific Edge’s US laboratory
and is charged by CMS with making Medicare medical policy decisions.

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.