US COURT LACKS JURISDICTION TO HEAR PACIFIC EDGE CLAIM

24 April 2025


US COURT LACKS JURISDICTION TO HEAR PACIFIC EDGE CLAIM
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes
the US District Court for the Middle District of Pennsylvania has determined that it does not
have jurisdiction to conduct judicial review of ‘Genetic Testing in Oncology: Specific Tests’
(L39365) Local Coverage Determination.
The judgment means the court is not able to consider the merits of Pacific Edge’s legal
complaint filed in the US District Court on 19 February 2025 about the LCD, despite Judge
Neary noting in her ruling that “the company has also marshalled incredibly compelling facts
for why its test is a medical marvel.”
The judgment was published around 4:15pm ET on 23 April 2025 and means the remaining
avenue for L39365 not to become effective on 24 April 2025 in the USA is a policy action by
the Center of Medicare and Medicaid Services (CMS).
CMS has the authority to unilaterally extend the effective date of L39365 independent of the
Court’s ruling. Pacific Edge and associated parties have made the case for retirement of the
LCD or extension of the effective date to the incoming political appointees within CMS
1
, HHS
2

and OGC
3
. Pacific Edge is continuing to watch closely to determine what action, if any, CMS
will take and we will update the market as we receive further information.
Released for an 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.

1
Center for Medicare and Medicaid Services
2
The Department of Health and Human Services
3
Office of the General Counsel (of the Department of Health and Human Services)

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.