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Trading Halt Update: Novitas Proposes Changes to LCD

Regulatory29 July 2022PEBHealthcare

29 July 2022

TRADING HALT UPDATE: NOVITAS PROPOSES CHANGES TO LCD


DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB)

became aware overnight (NZT) of the inclusion of Cxbladder CPT codes in a draft proposal

for a different approach to determine which cancer biomarker tests are eligible for

reimbursement by Novitas.

The publication of the proposed approach for Genetic Testing in Oncology is set out in a draft

Local Coverage Determination (LCD, DL39365) and a draft Local Coverage Article (LCA,

DA59125).

Pacific Edge will provide its shareholders with further clarification of the implications for Pacific

Edge once it has received advice from its US legal team and other advisors prior to lifting the

current trading halt.



Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.


For more information:


Dr Peter Meintjes

Chief Executive

Pacific Edge

P: +64 22 032 1263



OVERVIEW www.pacificedge.co.nz 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.


About Cxbladder www.cxbladder.com

Cxbladder is a non-invasive genomic urine test optimized for the detection and management 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 2,000

US urologists in the diagnosis and management of more than 80,000 patients, including the option for

in-home sample collection. In New Zealand, Cxbladder is accessible to 70% of the population via public

healthcare and all residents have the option of buying the test online.

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