Novitas Proposes Expert Panel in Response to 2025 AUA Guide

15 SEPTEMBER 2025


NOVITAS PROPOSES EXPERT PANEL IN RESPONSE TO 2025 AUA
GUIDELINE
DUNEDIN, New Zealand – Pacific Edge (NZX, ASX: PEB) today announces it has received
notification from Medicare Administrative Contractor (MAC) Novitas that it intends to convene
an expert panel to consider coverage for tests mentioned in the 2025 update to the American
Urological Association (AUA) microhematuria guideline, including Cxbladder Triage.
The panel — known as a Contractor Advisory Committee (CAC) — is likely to be convened in
early 2026. It will be comprised of urology subject matter experts and will be tasked with
considering how to bring Medicare policy into alignment with the 2025 update to the AUA
guideline.
Pacific Edge notes that under the Medicare Program Integrity Manual, CAC meetings are
initiated by the MAC and generally precede the draft issuance of a new or substantially revised
Local Coverage Determination (LCD).
Pacific Edge Chief Executive Dr Peter Meintjes said: “We are pleased that Novitas has
acknowledged the importance of the AUA microhematuria guideline and is taking a robust and
credible approach to policy development by convening a panel of urologists who understand
the latest update to the guideline. It is also recognition of the important role that randomized
controlled trials like our STRATA
1
study and guidelines play in the development of medical
policy like LCDs.”
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

1
Lotan et al. (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to
Cystoscopy in Patients with Microhematuria. The Safe Testing of Risk for Asymptomatic Microhematuria Trial. The
Journal of Urology Vol 212 1-8 Jul 2024.

2

Cxbladder is a suite of non-invasive genomic urine tests optimized for the risk stratification of
urothelial cancer in patients presenting with microhematuria and those being monitored for
recurrent disease. The tests help improve the overall patient experience, while prioritizing time
and clinical resources to optimize practice workflow and improve efficiency.
Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than
25 peer reviewed publications, and Cxbladder Triage is now included in the American
Urological Association’s Microhematuria Guideline. To drive increased adoption and improved
patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies
designed to generate further clinical utility evidence.
Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and
South America. In the US, the test has been used by over 5,000 urologists who have ordered
more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the
population via public healthcare and all residents have the option of buying the test online.