Clarification of Novitas Timeline

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:
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