Trading Halt Update: Novitas Proposes Changes to LCD
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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