Clarification of Novitas Timeline

2 June 2023
CLARIFICATION OF NOVITAS TIMELINE
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today wishes
to clarify the expected timeline for the finalization or withdrawal of the draft Local Coverage
Determination (LCD) and the associated Local Coverage Article (LCA) covering the reimbursement of
its Cxbladder tests by Medicare, the US national health insurance provider.
As noted most recently in its FY 23 results announcement, released on 25 May 2023, Pacific Edge
stated that it’s understanding was that Novitas, the Medicare Administrative Contractor with
responsibility for its US laboratory, must either finalize or withdraw the proposed LCD (DL 39365) and
the associated LCA (DA 59125) that cast Cxbladder’s continued Medicare coverage into doubt, by 28
July 2023 (NZT).
Following further review, and discussions with its advisors and other industry participants, Pacific Edge
now understands that Novitas must either finalize or withdraw the proposed LCD and LCA by 9 June
2023 (NZT), 12 months after the original date of posting, not 12 months after date of last revision as
previously communicated. We understand that there is no required announcement from Novitas upon
passing the expiration date.
Pacific Edge continues to receive coverage for Cxbladder tests, has not been notified by Novitas of any
intent to finalize or withdraw and will update the market as soon as we are aware of additional
information related to the LCD and LCA.
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 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.